Medtronic, Inc.

Patent Trials and Appeals Board

Aug 3, 2021

2021000749 (P.T.A.B. Aug. 3, 2021)

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.
15/643,172 07/06/2017 Robert W. Stadler C00010688.USC7 1032
10723 7590 08/03/2021
Medtronic Inc. (CRDM/MRG)
710 Medtronic Parkway NE
MS LC-340
Minneapolis, MN 55432-5604
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
08/03/2021 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):
ptodocketing@mrgs.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT W. STADLER and SUBHAM GHOSH
Appeal 2021-000749
Application 15/643,172
Technology Center 3700
Before BRETT C. MARTIN, LISA M. GUIJT, and
MICHAEL L. WOODS, Administrative Patent Judges.
MARTIN, 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 22–25 and 27–34. 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(a). Appellant identifies the real parties in interest as Medtronic, Inc.
and Medtronic PLC. Appeal Br. 2.
Appeal 2021-000749
Application 15/643,172

2
CLAIMED SUBJECT MATTER
The claims are directed to noninvasive assessment of cardiac
resynchronization therapy. Claim 22, reproduced below, is illustrative of the
claimed subject matter:
22. A method comprising:
(a) applying an electrode apparatus having a plurality of
electrodes to a torso of a patient;
(b) introducing one of a right ventricular (RV) lead to a
right ventricle or a right atrial (RA) lead to a right atrium;
(c) delivering noninvasively ultrasonic energy to a target
tissue selected from a set of target tissues;
(d) in response to delivering ultrasonic energy to the
cardiac tissue, receiving, with a processing unit, a torso-surface
potential signal from each of a plurality of electrodes distributed
on a torso of a patient for the target tissue;
(e) sensing signals from one of the RA lead and the RV
lead in response to delivering ultrasonic energy;
(f) for at least a subset of the plurality of electrodes,
calculating, with the processing unit, a torso-surface activation
time based on the signal sensed from the electrode;
(g) repeating steps (c) through (f) for another tissue site to
obtain cardiac resynchronization data;
(i) determining whether the tissue site or the another tissue
site provides optimal cardiac resynchronization; and
(j) in response step (i), selecting one of the tissue site and
the another tissue site that provides optimal cardiac
resynchronization for locating a medical electrical lead.
Appeal Br. 14 (Claims App.).

Appeal 2021-000749
Application 15/643,172

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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Gosh US 2012/0284003 A1 Nov. 8, 2012
Ramanathan US 2014/0135866 A1 May 15, 2014
Linveh et al., Extracorporeal acute cardiac pacing by High Intensity
Focused Ultrasound, 115 Progress in Biophysics and Molecular Biology,
140–153 (2014).
REJECTIONS
Claims 22–24 and 29–33 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Gosh and Linveh. Final Act. 3.
Claims 25, 27, 28, and 34 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Gosh, Linveh, and Ramanathan. Final Act. 5.
OPINION
The Examiner finds that Gosh teaches all elements of claim 22 except
for “a step/means for delivering ultrasound energy (e.g., HIFU) to the
cardiac tissue for pacing,” which the Examiner finds is taught in Linveh.
Final Act. 4. We note that in explaining Gosh, the Examiner generally refers
to the subject matter at issue, but does not specifically state where each
specific element of the claim is taught. During prosecution, Appellant
pointed out that the Examiner did not address element (e) of claim 22, which
requires that the sensing is done from either the RA or RV lead. See Appeal
Br. 8. In the Examiner’s Response to Arguments in the Final Action, the
Examiner addressed element (e) by stating “that the modified system and
method as described above would include the step of sensing signals from
one of the RA lead and the RV lead in response to delivering ultrasonic
energy when the CRT is iteratively evaluated.” Final Act. 6–7.
Appeal 2021-000749
Application 15/643,172

4
As Appellant correctly argues, however, “stimulation of the heart in
order to determine the tissue site that produces optimal cardiac
resynchronization . . . is not done using the electrodes on the leads of Gosh.”
Appeal Br. 11. Appellant is also correct that “Gosh (sic) similarly uses only
surface electrodes to measure dissynchrony even when pacing pulses are
provided by the leads.” Appeal Br. 12. In fact, in Gosh, “sensing of signals
to evaluate the effectiveness of CRT is done using torso electrodes rather
than electrodes on the leads.” Reply Br. 4.
The Examiner’s alleged support for Gosh teaching sensing from the
leads is a general statement in Gosh that “IMD 100 may also be configured
to sense the electrical activity of heart 10 through the electrodes on one or
more of leads 102, 104 and 106.” See Advisory Action 2 dated April 7,
2020 citing to Gosh ¶ 28. We agree with Appellant that Gosh’s “general
teaching is mooted by the specific disclosure in Gosh (sic), as acknowledged
by the Examiner in his Answer, that in Gosh (sic) sensing to obtain cardiac
resynchronization data is done using torso electrodes.” Reply Br. 6. We
further agree with Appellant that “[w]hatever sensing functions of the leads
may have been included as part of CRT pacing using the leads in Gosh (sic)
is thus irrelevant as CRT pacing using the leads isn’t happening.” Appeal
Br. 12. In other words, although Gosh mentions a sensing capability for the
RA and RV leads, those leads are not disclosed as being used as sensors
during the method taught in Gosh that is applicable to the claims. As such,
the Examiner has no support in the prior art for the sensing from the leads as
required in the claims. Accordingly, we do not sustain the Examiner’s
rejection over Gosh and Linveh. We likewise do not sustain the rejection
Appeal 2021-000749
Application 15/643,172

5
over Gosh, Linveh, and Ramanathan because this rejection relies on the
same error discussed above with regard to Gosh and Linveh.
CONCLUSION
The Examiner’s rejections are reversed.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
22–24, 29–
33
103 Gosh, Linveh 22–24, 29–
33
25, 27, 28,
34
103 Gosh, Linveh,
Ramanathan
25, 27, 28,
34
Overall
Outcome
22–25, 27–
34

REVERSED