CARDIAC PACEMAKERS, INC.

Patent Trials and Appeals Board

Sep 2, 2021

2021001059 (P.T.A.B. Sep. 2, 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.
14/919,233 10/21/2015 Benjamin J. Haasl 1001.3628101 1407
11050 7590 09/02/2021
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
HERBERMANN, ERICH G.
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
09/02/2021 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte BENJAMIN J. HAASL and BRIAN L. SCHMIDT 1
________________

Appeal 2021-001059
Application 14/919,233
Technology Center 3700
________________

Before BIBHU R. MOHANTY, BRADLEY W. BAUMEISTER, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

BAUMEISTER, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1, 10, and 21–38, which constitute all claims pending in
this application. Appeal Br. 2–3. We have jurisdiction under 35 U.S.C.
§ 6(b).
The Board conducts a limited de novo review of the appealed
rejections for error based upon the issues identified by Appellant, and in
light of the arguments and evidence produced thereon. Ex parte Frye,
94 USPQ2d 1072, 1075 (BPAI 2010) (precedential).
We reverse.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies Cardiac Pacemakers, Inc. as the real party in interest. Appeal
Brief (“Appeal Br.”), at 4, filed August 24, 2020.
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Application 14/919,233

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CLAIMED SUBJECT MATTER
Appellant describes the present invention as follows:
Delivery devices, systems, and methods for delivering
implantable leadless pacing devices are disclosed. An example
delivery device may include a proximal section including a
deflection mechanism for deflecting the proximal section, and a
distal holding section extending distally of a distal end of the
proximal section and defining a cavity therein for receiving an
implantable leadless pacing device. The distal holding section
may be structured to have portions that flex and bend while
allowing the implantable device to be recaptured within the distal
holding section.
Spec. Abstr.
Independent claim 1, reproduced below, illustrates the subject
matter of the appealed claims:
1. A delivery device for delivering an implantable
leadless pacing device, the delivery device comprising:
a proximal section having an outer diameter;
a distal holding section extending distally of a distal end
of the proximal section, the distal holding section defining a
cavity therein for receiving an implantable leadless pacing device
and the distal holding section having an outer diameter greater
than the outer diameter of the proximal section;
wherein the distal holding section comprises a braided
reinforcing element covered by a polymeric body;
wherein a proximalmost end of the braided reinforcing
element is disposed within the distal holding section.

STATEMENT OF THE REJECTIONS
Claims 1, 10, 21, 23, 24, 28, 29, 31, 32, 36, and 37 stand rejected
under 35 U.S.C. § 103 as being unpatentable over the combined teachings of
Steingisser (US 2013/0103047 A1; published Apr. 25, 2013) and
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Ju (US 6,217,566 B1; issued Apr. 17, 2001). Final Action (“Final Act.”), at
2–10, mailed April 2, 2020.
Claims 22, 30, and 38 stand rejected under 35 U.S.C. § 103 as being
unpatentable over the combined teachings of Steingisser, Ju, and Kellerman
(US 2013/0123827 A1; published May 16, 2013). Final Act. 10–12.
Claims 25–27 and 33–35 stand rejected under 35 U.S.C. § 103 as
being unpatentable over the combined teachings of Steingisser, Ju, and
Levine (US 6,726,700 B1; issued Apr. 27, 2004). Final Act. 12–14.

DETERMINATIONS AND CONTENTIONS
The Examiner finds that Steingisser discloses most of the limitations
of independent claim 1, but does not disclose the claim language, “wherein
the distal holding section comprises a braided reinforcing element covered
by a polymeric body” or that “[the] proximalmost end of the braided
reinforcing element is disposed within the distal holding section.” Final
Act. 2–3. The Examiner finds that Ju teaches that it was known to have a
braided reinforcing element covered in a polymeric body in the distal section
of a catheter. Id. at 3 (citing Ju col. 1, ll. 50–60; Fig. 2). The Examiner
further determines that it would have been obvious
to have modified the device of Steingisser to have the braided
reinforcing layer covered in the polymeric body . . . in the distal
segment (located inside the distal section 235 of Steingisser) of
the device in view of Ju to improve the kink resistance of the
distal holding section.
Id. (citing Ju col. 1, ll. 50–60) (emphasis added).
Appellant argues various reasons for why no reasonable basis exists to
modify the distal-most portion 235 of Steingisser’s device with the teachings
of Ju to arrive at Appellant’s invention, as claimed. Appeal Br. 9–15. For
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Application 14/919,233

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example, Appellant argues one of ordinary skill would understand that the
distal-most portion 235 of Steingisser would not be subject to kinking during
either advancement or withdrawal of the outer tube. Id. Appellant then
argues that because the Examiner has not established that the distal-most
portion 235 would be subject to kinking, the Examiner has not established a
sufficient reason to add the braid of Ju to the device of Steingisser. Id. at 14.
In the Examiner’s Answer mailed October 2, 2020 (“Ans.”), the
Examiner reiterates that the purpose for the modification is to “provide extra
radial support to prevent the distal portion [of Steingisser] from kinking
when forces are applied to the distal end when maneuvering the tool through
the body.” Ans. 5. The Examiner responds to Appellant’s arguments,
“[t]here is no mention in Steingisser to support the claim that the device[,] as
described[,] has a distal-most portion that is resistant to kinking in any way.”
Id. at 6. The Examiner reasons without providing support, “the distal end is
subject to compression both during insertion and during withdrawal.” Id.
at 8.

ANALYSIS
In order to modify Steingisser’s distal-most portion 235, the Examiner
relies on Ju’s teaching of providing a braided reinforcing element 120 in the
“most distal section” 102 of Ju’s catheter 100. Final Act. 3 (citing Ju’s distal
section 102; Fig. 2). But Ju’s most distal section 102 does not sufficiently
correspond to Steingisser’s distal-most portion 235.
Steingisser describes its distal-most portion 235 as being an enlarged
distal end of the outer tube 230—the distal end in which an implantable
device 100 is loaded. Steingisser ¶¶ 19, 22; Fig. 2A. This distal-most
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portion 235 has a length of approximately 3 cm to contain device 100.
Steingisser ¶ 19.
In contrast, Ju’s most distal section 102 is an elongated section of
catheter 100 that is the same outer diameter as the proximal section 104 and
joint region 106. Ju Fig. 1; col. 1, ll. 15–17 (“the catheter assembly uses
long conical joints between component tubular members to provide smooth
and strong transitions between those members.”); id. at col. 2, ll. 19–21
(“The invention utilizes the concept of combining one or more polymeric
tubes with a metallic braid comprising ribbons of a super-elastic alloy.”). Ju
sets forth examples where the distal section has braid lengths of 14.5 cm and
22.5 cm. Id. at col. 14, ll. 1–2. These exemplary braid lengths of Ju’s distal
section are five to seven times longer than the 3 cm length of Steingisser’s
distal-most portion 235.
Moreover, Ju’s most distal section 102 does not constitute the distal
end of Ju’s catheter. Ju’s distal section 102 is proximal of the catheter’s
radio opaque marker 108 and unlabeled tip. Ju Fig. 1. As such, Ju’s most
distal section 102 appears to correspond more closely to Steingisser’s
flexible elongate outer tube 230 than it does to Steingisser’s shorter-length
and larger-diameter distal-most portion 235.
On this record, then, the Examiner does not provide sufficient
evidence or factual basis to support the determination that one of ordinary
skill in the art would have expected Steingisser’s distal-most portion 235 to
be prone to kinking. As such, the Examiner has not established that it would
have been obvious to modify Steingisser’s distal-most portion 235 so as to
include a braided reinforcing element covered by a polymeric body, as
recited by claim 1.
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The initial burden is on the Examiner to support the Examiner’s
findings by a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849
F.2d 1422, 1427 (Fed. Cir. 1988). Only when the Examiner sets forth a
prima facie case does the burden shift to Appellant to rebut the Examiner’s
evidence. In re Sullivan, 498 F.3d 1345, 1351 (Fed. Cir. 2007). Because the
Examiner has not met the initial showing, Appellant has no burden to show
that Steingisser’s distal-most portion 235 is resistant to kinking. See Ans. 6
(wherein the Examiner determines that Appellant has not shown
Steingisser’s distal-most portion to be resistant to kinking).
For the foregoing reasons, Appellant has persuaded us of error in the
Examiner’s obviousness rejection of independent claim 1. Accordingly, we
reverse the Examiner’s rejection of that claim and of claims 10, 21, 23, 24,
28, 29, 31, 32, 36, and 37, which either depend from claim 1 or otherwise
include similar claim language.2
Regarding the further rejections of claims 22, 25–27, 30, 33–35, and
38, the Examiner does not rely on either of the additionally cited references,
Kellerman and Levine, to cure the deficiency of the obviousness rejection

2 We only address the narrow question of whether the Examiner has
established that it would have been obvious to modify Steingisser’s distal-
most portion 235, as proposed, for the specific purpose of preventing
kinking. Because that was the sole stated basis for modifying Steingisser,
we do not address any other potential reasons for why one would have been
motivated to make an enlarged distal-most portion of a leadless-pacing
delivery device, as claimed, flexible. See Frye, 94 USPQ2d at 1075 (The
Board conducts a limited de novo review of the appealed rejections for error
based upon the issues identified by Appellant, and in light of the arguments
and evidence produced thereon.).
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explained above. Final Act. 10–14. We, therefore, reverse the obviousness
rejections of these claims for the reasons set forth in relation to claim 1.

DECISION SUMMARY
In summary:

REVERSED

Claim(s)
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
1, 10, 21, 23, 24,
28, 29, 31, 32,
36, 37
103 Steingisser, Ju 1, 10, 21, 23,
24, 28, 29,
31, 32, 36, 37
22, 30, 38 103 Steingisser,
Ju, Kellerman
22, 30, 38
25–27, 33–35 103 Steingisser,
Ju, Levine
25–27, 33–35
Overall
Outcome
1, 10, 21–38