Ex Parte Sliwa et al

Patent Trials and Appeals Board

Apr 25, 2019

14214616 - (D) (P.T.A.B. Apr. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/214,616 03/14/2014
67337 7590 04/29/2019
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
FIRST NAMED INVENTOR
John W. Sliwa
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
OL-040101US/065513-000890 4603
EXAMINER
IP,JASONM
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
04/29/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ASJM_Patents@abbott.com
MN-IPMail@dykema.com
Patents@dykema.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN W. SLIWA, STEPHEN A. MORSE, and ZHENYI MA
Appeal2017-010825
Application 14/214,6161
Technology Center 3700
Before TA WEN CHANG, RACHEL H. TOWNSEND, and DAVID
COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
force-sensing tip assembly for a catheter. The Examiner rejected the claims
on appeal as obvious under 35 U.S.C. § 103(a) and indefinite under 35
U.S.C. § l 12(b ).
We affirm-in-part.
1 According to Appellants, the real party in interest is St. Jude Medical,
Atrial Fibrillation Division, Inc. App. Br. 1.
Appeal2017-010825
Application 14/214,616
STATEMENT OF THE CASE
The Specification states:
The present disclosure is directed to tip assemblies for
catheters that are capable of generating measurements that can
be used to provide an indication of the force with which the tip
is being applied to a body, such as tissue. The force-sensing tips
of the present disclosure provide omni-directional force
measurements, e.g. axial and bending force, applied by the tip.
Furthermore, the force-sensing tips of the present disclosure are
self-contained in that all measurements for determining force
applied by the tip can be obtained from within the tip itself,
without the need for external measurements from an imaging
system or the like.
Spec. ,-J 6.
Claims 1-24 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A force-sensing tip assembly for a catheter, the force-
sensing tip assembly comprising:
a tip shell;
an acoustic transducer disposed within the tip shell, the
acoustic transducer capable of generating an acoustic ping;
a first target spaced from the acoustic transducer within
the tip shell; and
a first spring in the tip shell, the first spring configured to
allow a relative position between the acoustic transducer and the
first target to change over a range;
wherein the first target is shaped and positioned to reflect
at least a portion of the acoustic ping back to the acoustic
transducer as a first echo over at least a portion of the range;
wherein the first echo provides a combined indication of
changes in both axial and bending positions of the first target
relative to the acoustic transducer.
App. Br. (Claims App.) 15.
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Appeal2017-010825
Application 14/214,616
The claims stand rejected as follows:
Claims 1-3, 7-15, 20, 21, and 24 under 35 U.S.C. § 103(a) as obvious
over Barley.2
Claim 4 under 35 U.S.C. § 103(a) as obvious over the combination of
Barley and Bonyak. 3
Claims 5, 6, 17, and 19 under 35 U.S.C. § 103(a) as obvious over the
combination of Barley and Ofek. 4
Claims 16 and 22 under 35 U.S.C. § 103(a) as obvious over the
combination of Barley and Tung. 5
Claim 18 under 35 U.S.C. § 103(a) as obvious over the combination
of Barley, Ofek, and Tung.
Claim 23 under 35 U.S.C. § 103(a) as obvious over the combination
of Barley, Tung, and Ofek.
Claim 7 under 35 U.S.C. § l 12(b) as indefinite for failing to
particularly point out and distinctly claim the subject matter which the
inventors regard as the invention.
OBVIOUSNESS
The same issue is dispositive with respect to all six of the Examiner's
obviousness rejections. Accordingly, we address all six rejections together.
2 Barley et al., U.S. Patent Publication No. 2012/0165669 Al, published
June 28, 2012 ("Barley").
3 Bonyak et al., U.S. Patent Publication No. 2012/0253167 Al, published
Oct. 4, 2012 ("Bonyak").
4 Ofek et al., U.S. Patent Publication No. 2007/0282211 Al, published Dec.
6, 2007 ("Ofek").
5 Tung et al., U.S. Patent Publication No. 2009/0099551 Al, published Apr.
16, 2009 ("Tung").
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Appeal2017-010825
Application 14/214,616
Barley discloses a medical ultrasound device. Barley Abstract.
Figures 8A and 8B (reproduced below) illustrate an embodiment of Barley's
ultrasound device. Id. ,i 38.
86
83
84
81
85 82
B
A
In the embodiment depicted in Figures 8A and 8B, two ultrasound
transducers 80 and 81 are positioned to emit and detect acoustic radiation
along the length of axes 82 and 83. Id. ,i 59.
Claim 1 requires "an acoustic transducer" that "generat[ es] an
acoustic ping" that is reflected back to the transducer as an echo, wherein the
echo "provides a combined indication of changes in both axial and bending
positions." Claims 20 and 24, the only other independent claims, include
similar limitations. More specifically, claim 20 requires an "acoustic
transducer" that "generat[ es] ... an acoustic ping" that is reflected back as
an echo, the echo being "indicative of axial and bending displacement."
Claim 24 requires a transducer and a target "wherein the target is configured
to provide the transducer with an echo that corresponds to a position and
angle of the flexible tip relative to the shaft." Thus, each of the independent
claims requires an echo indicative of two directional components.
In finding claims 1, 20, and 24 obvious, the Examiner acknowledges
that Barley does not "explicitly disclose that a first echo provides a
combined indication of changes in both axial and bending positions," and
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Appeal2017-010825
Application 14/214,616
that Barley does not "explicitly describe a single transducer being used to
detect both axial and lateral movement." Ans. 3. The Examiner finds
however, that Barley teaches that "contact force can be determined using a
single transducer or multiple transducers to detect a contact force" and that
"a single transducer would be sufficient in detecting the movements if the
axis between the transducer and transmission element is not parallel with
either the axial or lateral axes." Id. at 3-4. The Examiner then concluded
that it would have been obvious "to apply a single echo signal to detect[]
axial and lateral forces, [so] as to provide a minimal number of transducers
and therefore sav[e] space in the device." Id. at 4.
Appellants argue that Barley does not disclose or suggest "a single
transducer that transmits an acoustic ping that is sensed by the transducer as
a first echo of the acoustic ping that provides a combined indication of both
axial and bending positions of a first target relative to the ultrasound
transducer." App. Br. 7.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992), "the
examiner bears the initial burden ... of presenting a prima facie case of
unpatentability." Appellants have persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
The Examiner does not identify, and we do not find, a disclosure in
Barley of a transducer that generates or receives an echo signal indicative of
two directional components. The Examiner contends that Barley discloses
that a single transducer can be used in place of multiple transducers that each
cover an "individual axis of interest." Ans. 12. However, in doing so, the
Examiner appears to have taken Barley's statement that "[t]he contact force
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Appeal2017-010825
Application 14/214,616
can be determined similarly as with a single transducer" out of context. The
paragraph from which this statement was drawn is reproduced below.
FIG. 8 illustrates an embodiment of a medical device
where the device comprises at least two ultrasound transducers
80, 81, a first ultrasound transducer for emitting acoustic
radiation along the length axis 82, and at least a second
ultrasound transducer for emitting acoustic radiation along an
axis 83 which is tilted with respect to the length axis. The
acoustic path length between the transmission element and the
first ultrasound transducer is detected and the acoustic path
length between the transmission element and the at least second
ultrasound transducer is detected, and the acoustic path length
changes along the length axis and at least along the axis which is
tilted with respect to the length axis are thereby detected. In the
illustrated embodiment, two transducers are shown however
three or more may be used. In particular, three transducers can
advantageously [be] used in order to detect the acoustic path
length changes along three spatial axes to determine the 3D
displacement of the catheter tip. In an embodiment, the catheter
may monitor at multiple viewing angles using fluid lens or
multiple single-element transducers. The contact force can be
determined similarly as with a single transducer. It can be
calculated directly if the relationship between all ~L's and the
contact force is well-defined. Otherwise, a look-up table may be
used.
Barley ,i 59 ( emphasis added). In the above paragraph, the statement that
"contact force can be determined similarly as with a single transducer"
appears to mean that each of the multiple transducers operates in the same
manner it would as if each transducer was used by itself, with each
transducer detecting an acoustic path along a different directional axis. We
do not understand it to teach that a single transducer can be used to detect
multiple acoustic paths. Accordingly, this statement does not provide
support for the Examiner's position that Barley renders it obvious to
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Appeal2017-010825
Application 14/214,616
"calculate both axial and bending components using just a single
transducer." Ans. 13.
The Examiner asserts that it would have been possible to use a single
transducer and that "it would be a trivial matter of resolving the component
vectors of the ultrasound beam to arrive at the axial and bending
components." Id. We are not persuaded because even ifwe accept this
assertion as accurate, the Examiner has not identified any evidence in the
record of a transducer that generates or receives an echo that provides
indicia of both axial and bending components. As our reviewing court has
explained, "the Board cannot accept general conclusions about what is 'basic
knowledge' or 'common sense' as a replacement for documentary evidence
for core factual findings in a determination of patentability." KIS Himpp v.
Hear-Wear Techs., LLC, 751 F.3d 1362, 1366 (Fed. Cir. 2014) (internal
citation omitted) ( affirming Board decision that claims were not obvious
where the challenging party "failed to cite any evidence on the record to
support its contention" that claimed detachable mechanical and electrical
connection was known in the art). Because this deficiency is common to
each obviousness rejection, we reverse all six of the Examiner's obviousness
rejections.
INDEFINITENESS
Appellants do not address the Examiner's indefiniteness rejection.
We, therefore, summarily affirm the indefiniteness rejection. See MANUAL
OF PATENT EXAMINING PROCEDURE§ 1205.02 (9th Ed., Rev. 08.2017, Jan.
2018) ("If a ground of rejection stated by the examiner is not addressed in
the appellant's brief, appellant has waived any challenge to that ground of
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Appeal2017-010825
Application 14/214,616
rejection and the Board may summarily sustain it, unless the examiner
subsequently withdrew the rejection in the examiner's answer").
SUMMARY
In summary, we reverse the Examiner's rejection of claims 1-3, 7-15,
20, 21, and 24 under 35 U .S.C. § 103(a) as obvious over Barley.
We reverse the Examiner's rejection of claim 4 under 35 U.S.C.
§ 103(a) as obvious over the combination of Barley and Bonyak.
We reverse the Examiner's rejection of claims 5, 6, 17, and 19 under
35 U.S.C. § 103(a) as obvious over the combination of Barley and Ofek.
We reverse the Examiner's rejection of claims 16 and 22 under 35
U.S.C. § 103(a) as obvious over the combination of Barley and Tung.
We reverse the Examiner's rejection of claim 18 under 35 U.S.C.
§ 103(a) as obvious over the combination of Barley, Ofek, and Tung.
We reverse the Examiner's rejection of claim 23 under 35 U.S.C.
§ 103(a) as obvious over the combination of Barley, Tung and Ofek.
We affirm the Examiner's rejection of claim 7 under 35 U.S.C. §
l 12(b) as indefinite for failing to particularly point out and distinctly claim
the subject matter which the inventors regard as the invention.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C .F .R. § 1.13 6( a)( I).
AFFIRMED-IN-PART
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