BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Jul 30, 2021

2020005707 (P.T.A.B. Jul. 30, 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.
14/590,667 01/06/2015 CASS A. HANSON 8150BSC0245 5746
121974 7590 07/30/2021
Kacvinsky Daisak Bluni PLLC (8150)
2601 Weston Parkway, Suite 103
Cary, NC 27513
EXAMINER
CLARK, RYAN T
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
07/30/2021 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):
docketing@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CASS A. HANSON, DEREK C. SUTERMEISTER,
TIMOTHY A. OSTROOT, ROBERT N. SQUIRE,
JAMES M. ANDERSON, MARTIN R. WILLARD,
PATRICK A. HAVERKOST, JAN WEBER,
JEFFREY S. LINDQUIST, and DANIEL J. HORN
Appeal 2020-005707
Application 14/590,667
Technology Center 3700
Before JENNIFER D. BAHR, CHARLES N. GREENHUT, and
MICHELLE R. OSINSKI, Administrative Patent Judges.
GREENHUT, 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 1–20. We have jurisdiction under
35 U.S.C. § 6(b).

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Br. 3.
Appeal 2020-005707
Application 14/590,667
2
We REVERSE.
CLAIMED SUBJECT MATTER
The claims are directed to flexible circuits including ablation
electrodes having enhanced tear resistance. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
A medical device for sympathetic nerve ablation, comprising:
a catheter shaft having a longitudinal axis;
an expandable balloon disposed on the catheter shaft, the balloon
being capable of shifting between an unexpanded configuration
and an expanded configuration; and
an elongate electrode assembly constructed as a flexible circuit
having a plurality of layers, the electrode assembly mounted on
an outer surface of the balloon, wherein the flexible circuit
comprises a distal electrode pad and a tail extending proximally
from the distal electrode pad;
wherein a first layer of the plurality of layers of the flexible
circuit has an initial tear strength of greater than 7.5 N (1.7 lbf)
according to ASTM D-1004-09.
The prior art relied upon by the Examiner is:
Name Reference Date
Chang et al.
hereinafter
(“Chang”)
US 2008/0177242 A1 July 24, 2008
Tilson et al.
hereinafter
(“Tilson”)
US 2009/0299374 A1 Dec. 3, 2009
Salahieh et al.
hereinafter
(“Salahieh”)
US 2010/0204560 A1 Aug. 12, 2010

REJECTIONS
1. Claims 1 and 4–20 are rejected under 35 U.S.C. § 103 as being
unpatentable over Salahieh et al. in view of Tilson et al.
Appeal 2020-005707
Application 14/590,667
3
2. Claims 2 and 3 are rejected under 35 U.S.C. § 103 as being
unpatentable over Salahieh and Tilson as applied to claim 1 above, and
further in view of Chang.
OPINION
The Examiner relies on Salahieh as disclosing the basic structure
claimed albeit without the layered electrode arrangement of independent
claims 1 and 16. Final Act. 2–3. The Examiner relies on Tilson to account
for this deficiency as follows:
Tilson, in an analogous medical device, teaches a balloon
wall (22) made of one or more layers (72) (par. [0244]) where
the balloon wall fails in a tear strength test at 134 lbf (par.
[0242]), the layer (72) have a fiber tape matrix made of
reinforcing fibers (par. [0364]), the reinforcing fibers can be
made of Kevlar (poly-paraphenylene terephthalamide) (par.
[0391] and Fig. 48), the tape that makes up the layers of the wall
can be woven (par. [0439]), the fiber layers (72) can have fibers
that are orientated in different directions (Figs. 74-77). This
material is considered an equivalent to that claimed. The
advantage of the different orientations of fibers leads to more
strength in a particular direction that is desired by the operator
(par. [0442]-[0444]) Therefore, it would have been obvious to
one of ordinary skill in the art at the time the invention was
effectively filed to modify the insulating layers taught by
Salahieh with the reinforced fiber tape layers taught by Tilson.
Final Act. 4.
The Examiner’s exact position is difficult to ascertain as the Examiner
does not provide a precise mapping of the limitations of claims 1 and 16 to
the applied prior art.2 Based on the discussion reproduced above it is not

2 “[T]he precise language of 35 U.S.C. § 102 that ‘(a) person shall be
entitled to a patent unless,’ concerning novelty and unobviousness, clearly
places a burden of proof on the Patent Office which requires it to produce
Appeal 2020-005707
Application 14/590,667
4
clear why the Examiner believes Tilson’s teachings with regard to the
makeup of the balloon would teach providing a tear resistant (claim 1) or
reinforced (claim 16) layer in Salahieh’s circuit assembly 89, 100.
In the Examiner’s Answer, the Examiner does not appear to discuss or
refer back to the analysis reproduced above in any meaningful way and
instead shifts the focus to Figures 43 and 45 of Tilson and the description
associated therewith. In this regard, the Examiner states:
as seen in Tilson Fig. 45 there is a circuit that is placed on the
balloon[.] 204 is the heating element, 206 are the traces, and 196
is a panel. Further to the point that par. [0354] states that 196 can
be a panel with reinforcing fibers making it like the different
balloon layers 76 that have the fibers going in different

the factual basis for its rejection of an application under sections 102 and
103.” In re Warner 379 F.2d 1011, 1016 (CCPA 1967). The Patent Trial and
Appeal Board is primarily a tribunal of review. See Ex Parte Frye, 94
USPQ2d 1072, 1075-1077 (BPAI 2010)(precedential). For that review to be
meaningful it must be based on some concrete evidence in the record to
support the Examiner’s factual findings and legal conclusions. In re Zurko,
258 F.3d 1379, 1386 (Fed. Cir. 2001). A rejection must be set forth in a
sufficiently articulate and informative manner as to meet the notice
requirement of § 132, such as by identifying where or how each limitation of
the rejected claims is met by the prior art references. In re Jung, 637 F.3d
1356, 1363 (Fed. Cir. 2011); see also 37 C.F.R. § 1.104(c)(2) (“When a
reference is complex or shows or describes inventions other than that
claimed by the applicant, the particular part relied on must be designated as
nearly as practicable. The pertinence of each reference, if not apparent, must
be clearly explained and each rejected claim specified.”); Gechter v.
Davidson 116 F.3d 1454, 1460 (Fed. Cir. 1997) (PTO must create a record
that includes “specific fact findings for each contested limitation and
satisfactory explanations for such findings.”). It is neither our place, nor
Appellants’ burden, to speculate as to the basis for rejecting claims. In re
Stepan, 660 F.3d 1341, 1345 (Fed. Cir. 2011) (It is the PTO’s obligation to
provide timely notice to the applicant of all matters of fact and law asserted.)
Appeal 2020-005707
Application 14/590,667
5
directions. This shows that the balloon materials of Tilson are
contemplated to be used as an insulated layer for circuitry.
Ans. 4–5.
Although the portion of Tilson cited in the Answer seems to have the
potential to be more relevant than that discussed in the Final Action, neither
Tilson nor the Examiner provides sufficient clarity with regard to the subject
matter on which the Examiner relies. Cited paragraph 354 of Tilson refers to
Figure 43, not Figure 45 of Tilson. Neither the Examiner nor Tilson clearly
explains the relationship between the devices depicted in Figures 43 and 45
of Tilson. See Tilson paras. 141–143, 354, 361. Reference numeral 196 does
not appear in Figure 43 of Tilson. It is not clear if Tilson intended to refer to
Figure 45 in paragraph 354 or reference numeral 186. Although unclear, the
latter seems more likely, as reference numerals 192 and 194, which do not
appear in Figure 45, are also mentioned. This might not be the case,
however, as Tilson depicts reference numeral 196 in Figure 45 but does not
mention reference numeral 196 in conjunction with the description
associated with Figure 45. Tilson para. 361. The relationship between vanes
186 and panel 196 is unclear. Like Appellant, we are ultimately uncertain as
to the relationship, if any, between any so-called “panel” associated with the
device depicted in Figure 43 of Tilson and potentially associated with some
type of reinforced layer, and the panel depicted in Figure 45 of Tilson
associated with a heating circuit. Reply Br. 8–10. The cited portion of
Tilson’s disclosure is unclear, and the Examiner does not make of record the
Examiner’s understanding of the precise relationship between the
arrangements depicted in Figures 43 and 45 of Tilson. Accordingly, on the
record before us, the Examiner appears to have made speculative
assumptions concerning Tilson’s disclosure upon which the Examiner relied
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Application 14/590,667
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to reach the conclusion of obviousness. “[L]egal determinations of
obviousness, as with such determinations generally, should be based on
evidence rather than on mere speculation or conjecture.” Alza Corp. v.
Mylan Laboratories, Inc., 464 F. 3d 1286, 1290 (Fed. Cir. 2006).
CONCLUSION
The Examiner’s rejections are reversed.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 4–20 103 Salahieh, Tilson 1, 4–20
2, 3 103 Salahieh, Tilson,
Chang
2, 3
Overall
Outcome
1–20

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
REVERSED