Cardionomic, Inc.

Patent Trials and Appeals Board

Sep 2, 2020

15446872 - (D) (P.T.A.B. Sep. 2, 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.
15/446,872 03/01/2017 Steven L. Waldhauser CAR.003C1 4699
20995 7590 09/02/2020
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
GETZOW, SCOTT M
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
09/02/2020 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):
efiling@knobbe.com
jayna.cartee@knobbe.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte STEVEN L. WALDHAUSER, STEVEN D. GOEDEKE, and
DUANE G. FRION

Appeal 2019-005269
Application 15/446,872
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, ANNETTE R. REIMERS, and
PHILIP J. HOFFMANN Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1–20. 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. The Appellant identifies the real party in interest as
Cardionomic, Inc. Appeal Br. 3 (“Appeal Br.” refers to the Appeal Brief
filed January 30, 2019).
Appeal 2019-005269
Application 15/446,872

2

STATEMENT OF THE CASE
Claimed Subject Matter
Claims 1, 6, and 13 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the claimed subject matter.
1. A catheter for use in electrical neuromodulation, the
catheter comprising:
an elongate body having a proximal end and a distal end;
a first opening in the elongate body;
a second opening in the elongate body, the second
opening between the proximal end of the elongate body and the
distal end of the elongate body and on a first side of the
elongate body;
a deflection lumen extending between the first opening
and the second opening;
an elongate deflection member having a first end and a
second end,
the deflection lumen having a size configured to
allow the deflection member to pass through the
deflection lumen,
the elongate deflection member configured to
extend out of the second opening with the first end of the
elongate deflection member proximal to the proximal end
of the elongate body upon application of pressure to the
first end of the elongate deflection member towards the
first opening,
the elongate deflection member comprising a
support wire comprising an austenitic metal alloy,
the support wire configured to provide column
strength and a predefined shape to the elongate deflection
member upon laterally extending out of the second
opening; and
a plurality of electrodes on a second side of the elongate
body, the second side opposite the first side, wherein extension
of the elongate deflection member out of the second opening is
laterally away from the plurality of electrodes and is configured
Appeal 2019-005269
Application 15/446,872

3

to bring the plurality of electrodes into contact with a luminal
surface of a pulmonary artery.

Rejections
Claims 1, 3–9, 11–17, 19, and 20 are rejected under 35 U.S.C. § 103
as unpatentable over Demarais et al. (US 2007/0135875 A1, pub. June 14,
2007) (“Demarais”) and Webster, Jr. (US 5,782,239, iss. July 21, 1988)
(“Webster”).
Claims 2, 10, and 18 are rejected under 35 U.S.C. § 103 as
unpatentable over Demarais, Webster, and Foster (US 2009/0281608 A1,
pub. Nov. 12, 2009).

ANALYSIS
Independent claims 1 and 6 recite “[a] catheter for use in electrical
neuromodulation” including “a second opening in the elongate body . . . on a
first side of the elongate body,” “the elongate deflection member configured
to extend out of the second opening,” and “a plurality of electrodes on a
second side of the elongate body, the second side opposite the first side.”
Appeal Br. 19, 20, Claims App.
The Examiner finds that Demarais’ port 805 and elongated
member 857 correspond to the claimed “second opening” and “elongate
deflection member,” respectively. See Non-Final Act. 2; Final Act. 2;
Ans. 3–4; Demarais ¶¶ 79–80, Fig. 8F.2

2 “Non-Final Act.” refers to the Non-Final Office Action mailed March 5,
2018. “Final Act.” refers to the Final Office Action mailed August 31, 2018.
“Ans.” refers to the Examiner’s Answer mailed April 30, 2019.
Appeal 2019-005269
Application 15/446,872

4

The Examiner finds that Demarais’ wall contact electrode 856
corresponds to one of the claimed “plurality of electrodes.” See Non-Final
Act. 2; Final Act. 2; Ans. 3–4. The Examiner does not find that Demarais
teaches “a plurality of electrodes on a second side of the elongate body, the
second side opposite the first side,” as recited in claims 1 and 6. In other
words, the Examiner does not rely on Demarais to teach the claimed number
and location of electrodes.
To remedy this deficiency, the Examiner determines “[t]o use more
than one electrode is considered to be an obvious design choice since it
would allow for more complete coverage, and merely yield predictable
results.” Non-Final Act. 2; see also Ans. 4–5. Our best understanding of the
foregoing is that the Examiner modifies Demarais’ electrode, as shown in
Figure 8F, so that there would have been multiple of the same type of
electrodes. This modification addresses the number of electrodes, but fails
to address the location of the electrodes.
Accordingly, the Examiner’s rejection needs to provide some
articulated reasoning with some rational underpinning as why one of
ordinary skill in the art would have positioned the electrodes opposite of
port 805. To remedy this deficiency, the Examiner appears to provide
numerous findings and modifications to Demarais’ teachings.
First, the Examiner finds that, “port [805] can be considered to be at
least opposite a portion of the electrode” (Final Act. 2) because “at least a
side of a circumferential electrode is opposite the port 805 of Demarais”
(Ans. 4 (emphasis omitted)). Alternatively, the Examiner determines
“[e]ven if the port 805 of Demarais were not on an opposite side of the
electrode 856, to make it on the opposite side would merely yield predictable
Appeal 2019-005269
Application 15/446,872

5

results, such as being able to more efficiently and effectively urge the
electrode to the vessel wall.” Id. at 3–4.
The Appellant argues that electrode 856 is a single electrode, which
appears to surround the perimeter of catheter 852 (i.e., a circumferential
electrode), and therefore, one cannot establish that it is positioned opposite
of port 805. See Appeal Br. 12–13; see also Reply Br. 4.3 Additionally, to
the extent that one would attempt to find that electrode 856 is positioned
opposite of port 805, the finding would be based on conjecture. See Appeal
Br. 13. We agree with the Appellant’s argument.
Second, the Examiner determines:
since the electrode is a wall contact electrode [856] and is
meant to stimulate the wall of the lumen, to use an electrode
that only surrounds a portion of the catheter, such as a point or
segment electrode, would merely yield the predictable result of
stimulating the lumen wall, and is considered to be well known
to the skilled artisan in the field.
Final Act. 2; see id. at 3 (citing Haverkost ¶ 71, Fig. 4a).4 The Examiner
explains that “port 805 of Demarais can be considered to be on an opposite
side of the segment electrode 856 since if it were not, the electrode would
not be urged in contact with the vessel wall in an effective manner.” Ans. 4.
Initially, we cannot identify from the record a rationale for modifying
the type of electrode from a circumferential electrode to a point or segment
electrode. Here, the Examiner only explains that the result of modification
is predictable, but does not provide a reason why one of ordinary skill in the
art would have modified the electrode type. Even assuming a rationale for

3 “Reply Br.” refers to the Reply Brief filed June 27, 2019.
4 Haverkost (US 2012/0029510 A1, pub. Feb. 2, 2012) (“Haverkost”).
Appeal 2019-005269
Application 15/446,872

6

this proposed modification was presented on the record, we cannot reconcile
the Examiner’s earlier rationale of “more complete coverage” for the
modification of having a plurality of electrodes with the rationale for
changing the type of electrode, as the latter would seem to have less
coverage. Further, the basis for the Examiner’s determination that as a result
of the modification of electrode type that the plurality of electrodes and
port 805 would necessarily be on opposite sides appears to be based on
conjecture.
Third, the Examiner either modifies the location of port 805 to be
located at the bottom of catheter 852 or suggests doing so. See Final Act. 2.
Once again, the Examiner only explains that the result of modification is
predictable, and fails to provide a rationale why one of ordinary skill in the
art would have modified the location of the port.
Lastly, the Examiner fails to rely on Webster’s teachings in any
manner that would remedy the deficiency in the Examiner’s rejection as
discussed above.
In view of the foregoing, we do not sustain the Examiner’s rejection
of independent claims 1 and 6, and dependent claims 3–5, 7–9, 11, and 12 as
unpatentable over Demarais and Webster.
Independent claim 13 has different requirements than independent
claims 1 and 6. See Appeal Br. 21, Claims App. The Examiner recognizes
these differences in the Answer. See Ans. 3 (“independent claim 13 . . .
merely states that the deflection member extends out of the second opening
‘laterally away from the plurality of electrodes’”). However, the Examiner
rejects claim 13 on the same exact basis as claims 1 and 6. Non-Final
Act. 3. In the interest of fairness, for this case, we elect to not dissect
Appeal 2019-005269
Application 15/446,872

7

aspects of the Examiner’s rejection of claims 1 and 6 on an ad hoc basis to
conjure together a separate rejection of claim 13. Therefore, for the same
reasons as discussed above, we do not sustain the Examiner’s rejection of
independent claim 13 and dependent claims 14–17, 19, and 20 as
unpatentable over Demarais and Webster.
Further, we note that the Examiner fails to rely on Foster’s teachings
in any manner that would remedy the deficiency in the Examiner’s rejection
of independent claims 1, 6, and 13. Therefore, for the same reasons as
discussed above for claims 1, 6, and 13, we do not sustain the Examiner’s
rejection of dependent claims 2, 10, and 18 as unpatentable over Demarais,
Webster, and Foster.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § References/Basis Affirmed Reversed
1, 3–9,
11–17, 19,
20
103 Demarais, Webster

1, 3–9,
11–17, 19,
20
2, 10, 18 103 Demarais, Webster,
Foster
2, 10, 18
Overall
Outcome
1–20

REVERSED