Ex Parte Drasler et al

Board of Patent Appeals and Interferences

Jul 13, 2012

11549352 (B.P.A.I. Jul. 13, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte WILLIAM J. DRASLER, MICHAEL J. PIKUS,
ROGER N. HASTINGS, SCOTT R. SMITH,
MARTIN R. WILLARD, DANIEL M. LAFONTAINE,
DOUGLAS R. SAHOLT, and GRAIG L. KVEEN
____________

Appeal 2010-006903
Application 11/549,352
Technology Center 3700
____________

Before KEN B. BARRETT, JAMES P. CALVE, and
REMY J. VANOPHEM, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the rejection of claims
1-19 and 21-38. App. Br. 4. Claim 20 has been canceled. We have
jurisdiction under 35 U.S.C. § 6.
We AFFIRM.
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CLAIMED SUBJECT MATTER
Claim 1 is representative of the claimed subject matter on appeal:
1. A wireless electrode assembly, comprising:
an electrode to electrically stimulate heart wall tissue;
a circuit coupled to the electrode, the circuit configured
to deliver to the electrode electrical energy to stimulate the
heart wall tissue;
a body containing the circuit, the body sized and shaped
for percutaneous, transluminal delivery into inner heart wall
tissue via an intravascular route, and wherein the body carries
the electrode;
a first fixation structure extending from the body in a
generally forward orientation and being biased to shift from a
retained condition to an outwardly extended condition to
engage heart wall tissue;
a second fixation structure extending from the body in a
generally rearward orientation and being biased to shift from a
retained condition to an outwardly extended condition to
engage heart wall tissue; and
wherein the wireless electrode assembly is sized and
shaped to be implanted into an inner heart wall, and to fit within
a heart.
REJECTIONS
Claims 1-19, 21-23, 25-27, 29, 30, 32, 33, 34, and 36-38 are rejected
under 35 U.S.C. § 103(a) as unpatentable over Cox (US 6,141,588; iss. Oct.
31, 2000) and Schwartz (US 2002/0077556 A1; pub. Jun. 20, 2002).
Claims 24, 28, 31, and 35 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Cox, Schwartz, and Saadat (US 6,363,938; iss. Apr. 2,
2002).

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ANALYSIS
Claims 1-19, 21-23, 25-27, 29, 30, 32, 33, 34, and 36-38 as unpatentable
over Cox and Schwartz
Appellants argue claims 1-19, 21-23, 25-27, 29, 30, 32, 33, 34, and
36-38 as a group and separately argue claims 2, 3, and 13. App. Br. 19-25;
Reply Br. 4-5. We select claim 1 as representative of the group (see 37
C.F.R. 41.37(c)(1)(vii) (2011)) and address Appellants’ arguments for
claims 2, 3, and 13. Claims 4-12, 14-19, 21-23, 25-27, 29, 30, 32, 33, 34,
and 36-38 stand or fall with claim 1. See App. Br. 25.
Claims 1, 4-12, 14-19, 21-23, 25-27, 29, 30, 32, 33, 34, 36-38
The Examiner found that Cox discloses a wireless electrode assembly
with an electrode and circuit configured to delivery electrical energy to the
electrode to stimulate heart wall tissue but fails to disclose an electrode body
sized and shaped for percutaneous, transluminal delivery into inner heart
wall tissue or first and second fixation structures. Ans. 3-4. The Examiner
found that Schwartz discloses a cardiac sensor that is sized and shaped for
percutaneous, transluminal delivery with first and second fixation structures
65, 65. Ans. 4. The Examiner determined that it would have been obvious
to size Cox for percutaneous, transluminal implantation and anchor Cox with
fixture structures of Schwartz to achieve the understood benefits of reduced
size, increased reliability, and simplified operation. Ans. 4, 10.
Appellants argue that Cox’s corkscrew attachment is not a fixation
structure. App. Br. 20-21. Appellants also argue that Cox’s electrodes are
not sized and shaped for percutaneous transluminal delivery into inner heart
wall tissue via an intravascular route. App. Br. 21-22. These arguments do
not apprise us of error in the Examiner’s findings that Schwartz discloses
these features and these features can be combined with Cox. See Ans. 3-4.
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Appellants also argue that Cox is directed to an epicardial sensor or
stimulation electrode that is located outside of the heart and thus Cox is not
combinable with Schartz’s sensor that is implantable within the heart for
measuring and monitoring parameters and medical conditions. App. Br. 23.
Appellants also argue that Cox teaches away from implanting the electrode
satellites into an inner heart wall so that it would not have been obvious to
size Cox’s satellites to achieve percutaneous transluminal implantation and
anchoring of the stimulator with fixation structures. App. Br. 23-25. These
arguments are not persuasive because, as Appellants acknowledge, Cox
discloses that the electrode sensors and stimulators may be affixed to the
exterior or interior surface of the heart. Col. 9, ll. 27-29; Reply Br. 2. The
mere disclosure of alternative designs does not teach away from any of the
alternatives and a general preference for one alternative does not teach away
unless a reference criticizes, discredits, or discourages a claimed solution.
DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327
(Fed. Cir. 2009); In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Appellants further argue that Cox’s epicardial satellites cannot be re-
packaged for percutaneous, transluminal delivery to inner heart wall tissue
without destroying Cox’s circuitry and neither Cox nor Schwartz discloses
how Cox can be re-packaged. Reply Br. 2-3; App. Br. 21-23. Appellants
assert that an epicardial and endocardial environments present different
requirements for an implantable assembly so that a device that is configured
for an epicardial environment cannot simply be moved to an endocardial
environment. Reply Br. 4. Appellants also contend that the mere fact that
Schwartz is implantable in the heart and contains electronics is not enough
to support an assertion that Schwartz could somehow teach a skilled artisan
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how to make Cox’s epicardial satellite into an intravascularly-deliverable
stimulation electrode assembly. Reply Br. 3. These arguments are not
persuasive because the test for obviousness is what the combined teachings
of the references would have suggested to skilled artisans, and it is not
necessary that the inventions of the references be physically combinable to
render a claimed invention obvious. In re Mouttet, 2012 WL 2384056, at *5
(Fed. Cir. Jun. 26, 2012) (citations omitted). Claim 1 calls for a circuit that
is coupled to an electrode and configured to deliver electrical energy to the
electrode to stimulate the heart wall tissue. The Examiner’s finding that a
skilled artisan could make an electrode and circuit of Cox implantable is
reasonable because Cox discloses that its electrodes can be implanted in the
heart interior (col. 9, ll. 27-29) and Schwartz’s discloses implantable sensors
and circuits. Appellants’ attorney arguments do not persuade us of error in
those findings. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Appellants further argue that Cox indicates that a physician can affix
the satellites to the exterior or interior surface of the heart, but Cox does not
disclose how a physician would deliver or affix a satellite in an interior of
the heart. Reply Br. 2-3. This argument is not persuasive because the
Examiner relied on Schwartz to disclose a cardiac sensor sized and shaped
for percutaneous, transluminal delivery into inner heart wall tissue with first
and second fixation structure (Ans. 4 (citing Figs. 10-16G)) and Appellants
have not apprised us of error in these findings.
Appellants also assert that the mere fact that a worker could rearrange
the parts of a reference device to meet the terms of the claims on appeal is
not sufficient to support a finding of obviousness because the prior art must
provide a motivation or reason for the worker in the art, without the benefit
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of Appellants’ Specification, to make the necessary changes in the reference
device. Reply Br. 4. Appellants also contend that the Final Office Action
and Answer fail to provide a motivation as to how or why Cox would be
rearranged or reconstructed and Schwartz also fails to do so.
A specific teaching, suggestion, or motivation to combine known
elements is not a requirement to establish obviousness. See KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418-19 (2007). The Examiner’s reason for
combining the teachings of Cox and Schwartz to render obvious the claimed
subject matter is supported by a rational underpinning of reducing the size of
Cox’s electrode for percutaneous, transluminal implantation, increased
reliability and simplified operation. Appellants’ arguments do not apprise us
of error in the Examiner’s reasoning or conclusion of obviousness.
Appellants also assert that an epicardial environment generally differs
from an endocardial environment and presents different requirements for the
implantable assembly so that a device that is configured for an epicardial
environment cannot simply be moved to an endocardial environment. Reply
Br. 4. This argument does not apprise us of error in the Examiner’s reasons
for combining Cox and Schwartz, particularly in view of Cox’s disclosure
that the satellite electrodes 200 may be implanted in the interior of a heart.
As such, we sustain the rejection of claims 1, 4-12, 14-19, 21-23, 25-
27, 29, 30, 32, 33, 34, and 36-38.
Claims 2, 3, 13
The Examiner took Official Notice that the ring-shaped structures of
Schwartz are equivalent to the tines recited in dependent claims 2 and 3 and
independent claim 13 and determined that it would have been obvious to use
Schwarz’s rings as fixation structures in implantable medical electronics to
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immobilize a device in cardiac tissue. Final Rej. 4; Ans. 5. Appellants did
not challenge the Examiner’s taking of official notice in their Appeal Brief.
In the Reply Brief, Appellants argue for the first time that Official Notice is
improper in this situation and that the Examiner failed to provide authority
for the assertion of equivalence of tines and ring-shaped fixation structures.
Reply Br. 5. Appellants’ failure to challenge the taking of Official Notice in
the Final Rejection after having an opportunity to do so in the Appeal Brief
means that the Examiner’s findings are conclusive. In re Ahlert, 424 F.2d
1088, 1091 (CCPA 1970). Moreover, the Examiner had a reasonable basis
for finding equivalence of the claimed tines and Schwartz’s opposing rings
65 that secure a body 52 to an inner heart wall 402 and oppose migration of
the body when outwardly extended as called for in claims 2, 3, and 13. See
Schwartz, paras. [0118-0120]; figs. 16A-16G. As such, we sustain the
rejection of claims 2, 3, and 13.
Claims 24, 28, 31, and 35 as unpatentable over Cox, Schwartz, and Saadat
Claims 24, 28, 31, and 35 depend from independent claims 1, 8, 13,
and 18 respectively, and call for at least one tine that is curved to inhibit
penetration of the inner heart wall tissue (claims 24, 28, 31) or inner heart
chamber wall (claim 35). The Examiner found that Saadat discloses at least
one tine 143 that is curved to inhibit penetration of inner heart wall tissue.
Ans. 8. Appellants argue that Saadat is a hollow perfusion enhancement
device that cannot carry the claimed wireless electrostimulation electronic
components without interfering with or destroying its perfusion purpose or
the wireless electrostimulation electronic components by exposing them to
body fluid and tissue and therefore teaches away from the present claims.
App. Br. 26; Reply Br. 26. This argument does not persuade us of error in
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the Examiner’s findings that Saadat discloses curved tines and that it would
have been obvious to incorporate such curved tines into the modified Cox
electrode assembly to inhibit penetration of inner heart wall tissue. Ans. 9.
The Examiner did not rely on Saadat to disclose a housing or assembly for
an electrode or circuit, but instead relied on Saadat to disclose a curved tine
to be used on the modified Cox electrode assembly. Ans. 8-9. As such, we
sustain the rejection of claims 24, 28, 31, and 35.
DECISION
The rejection of claims 1-19, 21-23, 25-27, 29, 30, 32, 33, 34, and 36-
38 under 35 U.S.C. § 103(a) as unpatentable over Cox and Schwartz is
AFFIRMED.
The rejection of claims 24, 28, 31, and 35 under 35 U.S.C. § 103(a) as
unpatentable over Cox, Schwartz, and Saadat is AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

MP