St. Jude Medical, Atrial Fibrillation Division, Inc.

Patent Trials and Appeals Board

Mar 31, 2020

14151273 - (D) (P.T.A.B. Mar. 31, 2020)

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.
14/151,273 01/09/2014 Riki Thao 0B-0479USC20/065513001365 4326
67337 7590 03/31/2020
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
ZINK, AMANDA L
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
03/31/2020 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 RIKI THAO and SAURAV PAUL
Appeal 2019-005092
Application 14/151,273
Technology Center 3700
Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK,
Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 27–46. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as St. Jude Medical,
Atrial Fibrillation Division, Inc. Appeal Br. 4.
Appeal 2019-005092
Application 14/151,273

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CLAIMED SUBJECT MATTER
Appellant’s invention relates to a system for assessing tissue contact
for flexible tip devices. Claims 27, 41, and 46 are independent. Claim 27,
reproduced below, is illustrative of the claimed subject matter:
27. A tissue contact sensing system comprising:
a plurality of sensors extending in a direction coaxial to a
central longitudinal axis of a shaft and offset within a tip of the
shaft; and
a signal processing device electrically connected to the
sensors, the signal processing device configured to receive
electrical signals from the plurality of sensors which are
generated in response to contact stress of the tip, and assesses a
direction of tissue contact on the tip based on the received
electrical signals.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Wuchinich US 5,176,677 Jan. 5, 1993
Shapiro US 5,645,065 July 8, 1997
Fleischman US 6,241,724 B1 June 5, 2001
Jain US 2002/0123749 Al Sept. 5, 2002

REJECTIONS
I. Claims 27, 32, 33, 35–41, 44 and 45 are rejected under 35
U.S.C. § 103(a) as unpatentable over Jain and Shapiro.
II. Claims 28–31, 42, and 46 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Jain, Fleischman, and Shapiro.
III. Claims 34 and 43 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Jain, Shapiro, and Wuchinich.
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OPINION
Rejection I, Claims 27, 32, 33, 35–41, 44 and 45
The Examiner finds that Jain discloses a tissue contact sensing system
having a plurality of sensors and a signal processing device that receives
electrical signals from the sensors, but that Jain’s signal processing device
does not assess a direction of tissue contact on the tip. Final Act. 2–3. The
Examiner finds that Shapiro discloses a system that can determined the
orientation and position of a catheter. Id. at 3. The Examiner considers that
it would have been obvious to modify Jain to use “an additional system of
determining direction of the catheter when in tissue as taught by Shapiro.”
Id. The Examiner concludes that the modified Jain “would allow for
accurate placement of a catheter without the use of external imaging such as
x rays which expose the physician needlessly to added radiation.” Id.
Appellant argues, inter alia, that “Shapiro generally teaches a catheter
localization system which relies-upon magnetic signals to determine a
position of a catheter tip within space.” Appeal Br. 8. According to
Appellant, “Shapiro does not appear to provide any teaching as to how these
magnetic signals, which are entirely unrelated to a (non-)contact state
between the tissue and catheter tip, could be used to determine tissue
contact, let alone direction of tissue contact, as claimed.” Id. at 8–9.
In response, the Examiner disagrees with Appellant’s assertion and
states that Jain’s system “can determine which electrodes are in contact with
tissue along the length of the distal tip and can deduce information regarding
the direction by knowing which electrodes are in contact and which
electrodes lack contact, and as broadly claimed by the appellant, could
assess a direction of tissue contact.” Ans. 9. The Examiner states that
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Application 14/151,273

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Shapiro teaches using sensors to indicate the direction or orientation of a
catheter, and that the combined teachings of Jain and Shapiro would “meet
the limitation of ‘assesses a direction of tissue contact on the tip based on the
received signals.’” Ans. 10.
Appellant replies that the Examiner does not explain how Shapiro’s
“sensing the orientation of the device” is the same as the claimed
“assess[ing] a direction of tissue contact on the tip.” Reply Br. 4. Appellant
contends that, although Shapiro senses, for example, a vertical orientation of
the device, it does not determine whether the vertically orientated device is
in contact with tissue, or a direction of tissue contact. Id.
Appellant has the better position. Claim 27 requires that electrical
signals from the plurality of sensors, generated in response to contact stress
of the tip, are used to determine a direction of tissue contact on the tip. The
Specification discloses that “piezoelectric sensors 320a-c respond to
mechanical stresses by generating electrical energy (e.g., a voltage),” i.e., the
claimed electrical signal. Spec. ¶ 65. “In addition to detecting tissue
contact, the relative magnitude and direction of the signal obtained from
each of the separate piezoelectric sensors 320a-c may be used to determine
the direction and plane of contact of the flexible tip device 310.” Id. Thus,
the signal from the sensor itself determines “a direction of tissue contact.”
As the Examiner correctly notes, Jain’s signal processing device “can
analyze the signals received by the sensors in order to determine a degree of
confidence of tissue contact along the length of the catheter. The system of
Jain can determine which electrodes are in contact with tissue along the
length of the distal tip.” Ans. 9. Specifically, in Jain, a linear array of
electrodes A–F are used, beginning “with electrode A and continuing in
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sequence though electrode F, the pressure exerted on each electrode 50 is
measured and compared to the reference pressure to assess electrode/tissue
contact adequacy.” Jain ¶ 74. The Examiner does not explain, however,
how using such a system, Jain “can deduce information regarding the
direction by knowing which electrodes are in contact and which electrodes
lack contact, and as broadly claimed by the appellant, could assess a
direction of tissue contact.” Indeed, the Examiner’s reasoning to use
Shapiro is to “allow for accurate placement of a catheter without the use of
external imaging.” Final Act. 3. If Jain’s system were able to “deduce
information regarding the direction” and “could assess a direction of tissue
contact,” Jain would be anticipatory and would not require external imaging.
Nor does the Examiner explain adequately how the addition of
Shapiro cures Jain’s inability to assess direction. As Appellant correctly
notes, “Shapiro generally teaches a catheter localization system which relies-
upon magnetic signals to determine a position of a catheter tip within space.”
Appeal Br. 8. Notwithstanding that Shapiro’s system requires an external
magnetic system as opposed to an external imaging system, the Examiner
does not explain adequately how the combined teachings of the references
would assess a direction of tissue contact on the tip based on the received
signals. An exemplary external sensing system of Shapiro is depicted in
Figure 4A, reproduced below.
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Figure 4A is a cross sectional, schematic view of a catheter and one
embodiment of the external probe of this invention that uses a vertically-
oriented output coil. Shapiro, 5:46–48.
As seen in Figure 4A, Shapiro’s “[s]ystem 10 includes an external
probe which includes pair 12 of perpendicular electromagnetic output coils
… moved over skin 7 to detect the depth of, and angular orientation of,
inductive sensor coil 30 carried by and proximate the distal end of catheter 9
located under skin 7.” Id. at 6:29–36. In Shapiro, “electromagnetic fields
generated from coil pair 12 penetrate skin 7 and induce voltages in sensor
coil 30. These induced signals are … digitized by analog-to-digital (AID)
converter 48. Id. at 6:44–50. “The digitized signals are provided to
microprocessor 50, which determines from these signals, and the drive
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signals provided to coil drive voltage generator 2 … the direction D (called
the ‘true direction’) in which the distal end of catheter 9 is pointing.” Id. at
6:51–56.
Thus, although we appreciate that Jain determines contact and Shapiro
determines direction, we agree with Appellant that this is not the same as
“assessing a direction of tissue contact on the tip based on the received
electrical signals.” Reply Br. 4. The Examiner does not explain sufficiently
how the combination would allow a signal from Jain’s sensors to determine
direction of tissue contact. Specifically, the combined teachings of Jain and
Shapiro separately determine whether there is contact, using the sensors on
the distal end of Jain’s catheter, and then separately determine which
direction the distal end is pointing using Shapiro’s external probe. Such a
combination requires a signal indicating contact and a separate induced
signal indicating direction. By contrast, claim 27 assesses a direction of
tissue contact on the tip based on the received electrical signals generated in
response to contact stress of the tip.
Accordingly, Appellant's argument on this point is persuasive, and we
do not sustain the rejection of claim 27 and associated dependent claims 32,
33, and 35–40 as unpatentable over Jain and Shapiro. We do not sustain the
rejection of independent claim 41, and claims 44 and 45, which depend from
claim 41, as unpatentable over Jain and Shapiro for the same reasons.

Rejection II; Claims 28–31, 42, and 46
Claims 28–31 depend from claim 27, and claim 42 depends from
claim 41. The Examiner does not rely on Fleischman in any way that would
remedy the deficiency in Rejection I discussed above. See Final Act. 6–7.
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Accordingly, we do not sustain the rejection of claims 28–31 and 42 as
unpatentable over Jain, Fleischman, and Shapiro for the same reasons.
Similar to claim 27, independent claim 46 requires a “plurality of
sensors generating electrical signals generated in response to contact stress
of the tip to detect at least one of axial stress, angular stress, and radial stress
indicative of a direction of tissue contact on the tip.” See Appeal Br. 21
(Claims App.). The Examiner makes the same findings as to Jain and
Shapiro, and relies on the reasoning that the combined teachings of Jain and
Shapiro would determine a direction of tissue contact. Final Act. 7. The
Examiner does not rely on Fleischman in any way that would remedy the
deficiency of the combination of Jain and Shapiro, discussed above. For the
same reasons as discussed in Rejection I, we do not sustain the rejection of
claim 46 as unpatentable over Jain, Fleischman, and Shapiro.

Rejection III; Claims 34 and 43
The Examiner does not rely on Wuchinich in any way that would
remedy the deficiency in Rejection I discussed above. See Final Act. 7–8.
Accordingly, we do not sustain the rejection of claims 34 and 43 as
unpatentable over Jain, Shapiro, and Wuchinich for the same reasons.
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Application 14/151,273

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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
27, 32, 33,
35–41, 44,
45
103(a) Jain, Shapiro 27, 32, 33,
35–41, 44,
45
28–31, 42,
46
103(a) Jain, Fleischman,
Shapiro
28–31, 42,
46
34, 43 103(a) Jain, Shapiro,
Wuchinich
34, 43
Overall
Outcome:
27–46
REVERSED