Ex Parte Van Herk et al

Patent Trial and Appeal Board

Mar 24, 2014

10509239 (P.T.A.B. Mar. 24, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHANNES JOHANNA VAN HERK and
MARKUS CORNELIS JAKOBUS LAZEROMS
__________

Appeal 2012-002080
Application 10/509,239
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
The following claims are representative.
9. The electrode according to claim 18, further including:
an insulating plastic layer covering the skin contacting face of the
electrically conductive elastic material with the surfaces of the conductive
metallic elements projecting through the insulating plastic layer to contact the
skin.

11. A monitoring system for monitoring a physiological activity of a
recipient, comprising:
a set of sensors including electrodes according to claim 18 to acquire
physiological data;
a device connected with the sensors to interpret the acquired
physiological data.

13. A monitoring system for monitoring a physiological activity of a
recipient, comprising:
a set of sensors configured to be positioned on a recipient’s skin to
acquire physiological data;
a storage and analysis device connected with the sensors to interpret
the acquired physiological data;
each of the sensors including at least one electrode having a working
surface adapted to contact the recipient's skin, each electrode including
a body of an electrically conductive elastic material with the working surface
exhibiting projections of the electrically conductive elastic material to enable
a substantially constant position of contact with the recipient’s skin, wherein
the electrode includes:
an electrode body of the electrically conductive elastic material, the
projections being integrally formed with the electrode body to provide a
unitary construction.

18. An electrode for use in a monitoring system, the electrode
comprising:
a layer of electrically conductive elastic material;
a plurality of submillimeter-sized prefabricated conductive metallic
elements inserted in and projecting from a skin contacting face of the layer of
electrically conductive elastic material, which metallic elements have
surfaces configured to contact skin of a patient to be monitored.
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19. The electrode according to claim 18, wherein the layer of
electrically conductive elastic material is mounted to an interior of a wearable
garment.

23. An electrode having a working surface adapted to contact a
recipient’s skin, the electrode comprising:
an electrode body of an electrically conductive elastic material with the
working surface exhibiting projections of the electrically conductive elastic
material integrally formed with the electrode body to provide a unitary
construction, the projections of the electrically conductive elastic material
providing a substantially constant position of contact with the recipient's skin.

Cited References

Dunseath, Jr. US 4,669,479 Jun. 2, 1987
Lundbáck US 4,646,747 Mar. 3, 1987
Granek et al. US 4,729,377 Mar. 8, 1988
Byers et al. US 4,969,468 Nov. 13, 1990
Ingman US 2002/0082668 A1 Jun. 27, 2002
Booker, III et al. US 2003/0114906 A1 Jun. 19, 2003

Grounds of Rejection
1. Claims 2, 6, 9, 11, 13, 15-18, 20, 23, 25, and 27 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Dunseath in view of
Lundbáck.
2. Claims 9, 11, 18, and 20, are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Byers in view of Booker.
3. Claims 12 and 14 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dunseath in view of Lundbáck and Ingman.
4. Claim 12 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Byers in view of Booker and Ingman.
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5. Claim 19 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Byers in view of Booker and Granek.
6. Claim 19 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dunseath in view of Lundbáck and Granek.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
4-10.

Discussion
ISSUE
The issue is: Does the cited prior art support the Examiner’s
conclusion that the claimed subject matter is obvious?

PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
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of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

ANALYSIS
Appellants provide separate argument for individual claims 9, 12-14,
16-20 and 23 and 25. (App. Br. 9-16.)
For all claims except claim 9, we agree with the Examiner’s fact
finding, statement of the rejection and responses to Appellants’ arguments as
set forth in the Answer. We find that the Examiner has provided evidence to
support a prima facie case of obviousness. If we do not mention specifically
separately argued claims below, we have adopted the Examiner’s
conclusions with respect to these claims. We provide the following
additional comment to argument set forth in the Answer.

A. Claim 13
Appellants argue that, “[n]either Dunseath nor Lundbáck disclose a
unitary construction, much less a unitary construction as described in
claim 13.” Br. 9. Appellants further argue that “[e]ven if one were to try to
modify Dunseath with Lundbáck as suggested by the Examiner, the resultant
combination would still not meet the limitations of claim 13.” (Id.)
Appellants contend that
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If one were to move the metallic surface of Lundbáck onto the
urethane foam surface of Dunseath, one would have a three or
more layer laminate construction including an insulating
adhesive layer, a polyeurethane foam layer, and a metal layer.
The projections would be on the metal layer. In this
combination, the projections would be of metal, not of the
electrically conductive elastomeric material. Moreover, the
electrode body, whether construed as the urethane foam pad 2
or the insulating adhesive pad 3, would not have integrally
formed projections. The projections would be on the additional
laminated metal layer.

(Br. 10.)

In response, the Examiner argues that

Applicant combines the flexible elastic pad of Dunseath with
the rigid plate of Lundback. However, Lundback was not cited
for its rigid plate. As disclosed below and in the prior office
actions, Lundback was cited for the teaching of an electrode
(e.g. 1) with a surface exhibiting uniform projections (e.g. 4) to
provide good contact especially in cases wherein there is hair
growth on the skin (e.g. Fig. 1, Col. 3, ll. 51-57). Therefore, the
Applicant’s arguments regarding the combination of the entire
structure of Dunseath with the entire structure of Lundback are
moot. Dunseath teaches a flexible conductive elastic electrode.
[Col. 4, ll. 63-67.] Lundback teaches an electrode with
projections that adheres to skin without having to shave the hair
off the patient.

(Ans. 10.)

We find the Examiner has the better argument. Dunseath discloses a
carbon loaded polyurethane foam for use as a dry electrode system for the
detection of biopotentials existing on the surface of the skin of a living body.
(Abstract, Col. 4, ll. 63-67.) Lundbáck discloses that it was well known in
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the prior art to use projections or protuberances associated with an electrode
applied to the skin (Abstract) “to give good contact, especially in case of
hair growth on the skin.” (Col. 3, ll. 50-57.) In KSR, the Supreme Court
acknowledged that:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421. Therefore, we agree with the Examiner that it would have been
obvious to incorporate the protuberances from the skin electrode of
Lundbáck into the carbon loaded polyurethane foam skin electrode of
Dunseath “to provide the predictable results of an electrode with projections
for providing increased contact in cases where the electrode is applied to the
skin over hair.” (Ans. 10-11.)
B. Claim 14
For claim 14, Appellants argue that
Claim 14 calls for holes to be defined through the
electrode body between the integral projections. Paragraph
[0016] of Ingman, referenced by the Examiner, teaches against
the use of such holes. Ingman is concerned with a bandage and
wants the wound to be able to breathe. Ingman teaches that
sweat is electrically conductive. Both Dunseath and Lundbáck
are trying to make electrically conductive contact with the skin.
To improve making such contact, sweat is desirable and one
would be taught against wicking it away.

(Br. 10.)
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The Examiner argues
Ingman teaches that it is known to use holes in the electrode as
set forth in Paragraph 16 to prevent sweat from short circuiting
the conducting layer of the electro-patch and provide a more
secure contact. It would have been obvious to one having
ordinary skill in the art at the time the invention was made to
modify the electrode as taught by Dunseath in view of
Lundback, with holes through the electrode as taught by
Ingman, since such a modification would provide the
predictable result of a[n] electrode with holes to prevent sweat
from short circuiting the conducting layer of the electrode and
provide a more secure contact with the skin.

(Ans. 11.)

In KSR, the Supreme Court acknowledged that:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421. Further, as noted by the United States Supreme Court,
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

(Id. at 417.)
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Therefore, we agree with the Examiner that it would have been
obvious to incorporate insulated holes into an electropatch or similar skin
electrode device to allow the skin to breathe and prevent sweat from short
circuiting the conducting layer of the patch/electrode. (Ingman ¶ [0016].)

C. Claim 18
For the rejection of claim 18 over Dunseath in view of Lundbáck,
Appellants argue that
The metallic skin contacting layer of Lundbáck does have
projections. However, these projections do not project out from
a layer of electrically conductive elastic material. Rather, the
metallic projections of Lundbáck are integral with the metal
layer. The metal layer and the projections are not described as
extending into an electrically conductive elastic material.

(Br. 11.)

As indicated above for claim 13, we agree with the Examiner that it
would have been obvious to incorporate the protuberances from the skin
electrode of Lundbáck into the carbon loaded polyurethane foam skin
electrode of Dunseath “to provide the predictable results of an electrode with
projections for providing increased contact in cases where the electrode is
applied to the skin over hair.” (Ans. 10-11.) With regard to the specific
“submillimeter” size of the protuberances, Lundbáck teaches that the
protuberances should be “small” in order to “give good contact” relative to
“hair growth on the skin” (Lundbáck, col. 3, ll. 55-57). Thus, Lundbáck
recognizes that the size is a results effective variable which may be adjusted
to maximize “good contact.” Appellants provide no rebuttal evidence
suggesting that the “submillimeter” size claimed differs from the “small”
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size of Lundbáck, nor that the “submillimeter” size has unexpected
properties relative to the “small” protuberances of Lundbáck.

D. For the rejection of Claim 18 in view of Byers and Booker,
Appellants argue that
Byers is directed to an implanted electrode which
includes a silicon base 7, a silicon dioxide layer 8, a metallic
layer 9, a spacing layer 10, and a top mask or fine mesh screen
11. Cones 12, 13 are deposited through the mask on the
metallic layer 9. Once these cones have been deposited, as is
common in chemical vapor deposition, the mask 11 and spacer
10 are removed. In Figure 7, a dielectric layer 15 of silicon
dioxide is deposited leaving tips of the cone exposed. The
silicon dioxide layers 8 and 15 are not disclosed as being either
elastic or conductive. To the contrary, the silicon dioxide layer
15 is disclosed as being insulating.

(Br. 13.)
As the Examiner has recognized, claim 18 is directed to a product, an
electrode, written in product-by-process claim language. (Ans. 13.) “Where
a product-by-process claim is rejected over a prior art product that appears to
be identical, although produced by a different process, the burden is upon
the applicants to come forward with evidence establishing an unobvious
difference between the claimed product and the prior art product.” In re
Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983).
The Examiner has cited Byers for the disclosure of an “electrode array
for sensing physiological signals through the skin, made out of a conductive
flexible/stretchable material with projections made out of metal that are
arranged in a uniform pattern on the surface of the electrode.” (Ans. 6.)
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Byers
[F]ails to disclose[] that the projections and electrode backing
are elastic and are used in combination with a storage and
analysis device. However Booker discloses a system for
monitoring ecg, evaluating ecg and then stimulating that utilizes
elastic electrodes (23) with elastic projections (23) to provide a
electrode that can conform to tissue so that it maintains constant
contact (Fig. 9, ¶42).

(Id.) Therefore, because Booker teaches it was well known in the art that
electrodes could be constructed as elastic electrodes with elastic projections
to provide an electrode that can conform to tissue so that it maintains
constant contact, we agree with the Examiner that it would have been
obvious to modify a similar electrode device with elastic projections.

E. Claim 9
Claim 9 recites “[t]he electrode according to claim 18, further
including: an insulating plastic layer covering the skin contacting face of the
electrically conductive elastic material with the surfaces of the conductive
metallic elements projecting through the insulating plastic layer to contact
the skin.”
Appellants argue that “[t]he Examiner does not explain what
structure in Dunseath or Lundbáck is considered the insulating plastic layer
covering the skin contacting face.” (Br. 12.)
Regarding claim 9, it is submitted that the combination of
Booker and Byers does not disclose or fairly suggest placing an
insulating plastic layer covering the skin contacting face of the
electrically conductive elastic material with surfaces of the
conductive metallic elements projecting through the insulating
plastic layer to contact the skin. Byers is directed to an
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implanted electrode. Long-term biological compatibility of all
elements is essential. Inert materials such as silicon dioxide
and inert metals are ideal for implanted electrodes. Plastic
materials and other polymers are problematic due to their
potential interaction with and degradation by various
body fluids.

(Reply Br. 7.)

The Examiner merely concludes that
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to have modified the
elastic layer with a conductive rubber and the insulating layer
with a plastic, since it has been held to be within the general
skill of a worker in the art to select a known material on the
basis of its suitability for the intended use as a matter of
obvious design choice. In re Leshin, 125 USPQ 416.

(Ans. 7, see also 13.)

We agree with Appellants that the Examiner has not supported the
rejection of claim 9 with evidence, and the rejection of claim 9 over
Dunseath in view of Lundbáck is reversed. The rejection of claim 9 over
Byers in view of Booker is reversed.
For claims 16, 20 and 25, Appellants have provided no evidence that
polyurethane is not a synthetic rubber as argued by the Examiner, and the
rejection of these claims is affirmed.
We concur with the Examiner’s analysis, evidence and conclusions
with respect to claims 12, 17, 19, and 23.

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CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections
which are affirmed, except the rejections of claim 9 over Dunseath in view
of Lundbáck and over Byers in view of Booker are reversed.

AFFIRMED-IN-PART

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