BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Oct 29, 2020

13709867 - (D) (P.T.A.B. Oct. 29, 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.
13/709,867 12/10/2012 RAJ SUBRAMANIAM 8150BSC0183 1000
121974 7590 10/29/2020
Kacvinsky Daisak Bluni PLLC
Cathy R Ryan
2601 Weston Parkway, Suite 103
Suite 103
Cary, NC 27513
EXAMINER
HULBERT, AMANDA K
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
10/29/2020 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RAJ SUBRAMANIAM and ZAYA TUN
____________

Appeal 2020-001655
Application 13/709,867
Technology Center 3700
____________

Before JENNIFER D. BAHR, MICHELLE R. OSINSKI, and
SEAN P. O’HANLON, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1–11, 15, 16, and 18–24.2 We have jurisdiction
over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Br. 2.
2 Claims 12–14 and 17 are cancelled. See Amendment (Sept. 27, 2017).
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THE CLAIMED SUBJECT MATTER
Claims 1 and 16 are independent. Claim 1, reproduced below, is
illustrative of the subject matter on appeal.
1. An intravascular catheter for nerve modulation through the
wall of a blood vessel, comprising:
a shaft having a proximal end and a distal end and a
central axis;
a balloon disposed on the shaft and having a proximal
end, a distal end, an interior surface, and exterior surface, a
lumen defined by the interior surf ace, the balloon as molded
comprising a plurality of elongate ridges;
a first electrode disposed on the balloon;
a first elongate elastomeric member disposed between the
first electrode and the balloon, wherein the first elastomeric
member is a generally longitudinal elastomeric member that is
disposed between the elongate ridges of the balloon and is
under tension when the balloon is in an inflated state; and
a first radial elastomeric band that circumferentially
surrounds the balloon around a longitudinal axis of the balloon.

EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:

Name Reference Date
Whayne US 6,142,993 Nov. 7, 2000
Swanson US 6,640,120 B1 Oct. 28, 2003
Bencini US 8,128,617 B2 Mar. 6, 2012
Wang US 8,702,619 B2 Apr. 22, 2014
Demarais US 8,774,913 B2 July 8, 2014

THE REJECTIONS
I. Claims 23 and 24 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite. Final Act. 5.
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II. Claims 23 and 24 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description
requirement. Id. at 4.
III. Claims 1–10, 12, 13, 15, 16, and 21–24 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Swanson, Bencini, and Wang. Id.
at 5–9.
IV. Claims 11, 18, and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Swanson, Bencini, Wang, and Whayne. Id.
at 9–10.
V. Claim 20 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Swanson, Bencini, Wang, and Demarais. Id. at 10.

OPINION
Rejection I – Indefiniteness
Each of dependent claims 23 and 24 recites “wherein the first radial
elastomeric band exists independently of the balloon.” Appeal Br. 18–19
(Claims App.). The Examiner determines that the claims are indefinite
because “the phrase ‘exists independently’ does not clearly define a
relationship between the balloon and the band.” Final Act. 5.
Appellant argues that the identified claim language does not render
the claims indefinite because “th[e] recitation clearly defines a relationship
between the balloon and the band in that it establishes that the band is
independent of the balloon.” Appeal Br. 10; see also Reply Br. 11 (asserting
the identified claim language “merely requires that the . . . band [exists]
independently of the balloon and does not purport to define the
particularities of the relationship between them”). The broadest reasonable
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interpretation of the identified phrase “exists independently” merely requires
that the first radial elastomeric band is a distinct element of the claimed
intravascular catheter relative to the balloon, and does not specify whether or
not there is contact or attachment between the first radial elastomeric band
and balloon. This interpretation is consistent with Appellant’s Specification,
which describes that “[o]ne or more circumferential elastomeric members 26
may be disposed around the outside of the balloon.” Spec. 7:25–26. In
other words, each circumferential elastomeric member 26 is a distinct
element that surrounds balloon 22 (i.e., circumferential elastomeric
members 26 are not an integral part of balloon 22).
The Examiner takes the position that the Specification “merely
suggests that the elastomeric band is located on top of the balloon, not
whether they are attached or not attached to each other.” Ans. 5. However,
the Examiner has not explained, nor it is apparent, why the definiteness of
the phrase “exists independently” relates to whether or not the balloon and
radial elastomeric band are attached. That is, although we agree with the
Examiner that a broadest reasonable interpretation of “exists independently”
provides no information regarding whether the balloon and radial
elastomeric band are attached or not, thereby resulting in a broad
construction that encompasses both, such a concern addresses breadth, not
indefiniteness. See In re Miller, 441 F.2d 689, 693 (CCPA 1971); In re
Gardner, 427 F.2d 786, 788 (CCPA 1970) (“Breadth is not indefiniteness.”).
The Examiner does not explain adequately why the breadth of the claims
should be equated to indefiniteness in this case. In other words, the
identified claim language is sufficiently clear so as not to render the claims
indefinite.
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For these reasons, we do not sustain the rejection of claims 23 and 24
under 35 U.S.C. § 112, second paragraph, as being indefinite.

Rejection II – Written Description
The Examiner finds that Appellant’s Specification fails to provide
adequate written description support for the limitation in dependent claims
23 and 24 reciting that “the first radial elastomeric band exists independently
of the balloon.” Final Act. 4. In particular, the Examiner finds that “[t]he
specification does not specifically mention the ‘independence’ of the band
from the balloon and thus it does not appear the phrase has support in the
originally filed specification.” Id. Appellant argues that “the specification
provides sufficient support and guidance for one skilled in the art to make
and/or use the subject matter claimed.” Appeal Br. 9 (citing Spec. 6:15–22,
7:16–9:8).
The fundamental factual inquiry for ascertaining sufficient written
description is whether the specification conveys with reasonable clarity to
those skilled in the art that, as of the filing date sought, the inventor was in
possession of the invention as presently claimed. See Ariad Pharms., Inc. v.
Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); Vas-Cath
Inc. v. Mahurkar, 935 F.2d 1555, 1562–64 (Fed. Cir. 1991). “This inquiry
. . . is a question of fact,” and “the level of detail required to satisfy the
written description requirement varies depending on the nature and scope of
the claims and on the complexity and predictability of the relevant
technology.” Ariad, 598 F.3d at 1351. “[T]he specification must describe
an invention understandable to that skilled artisan and show that the inventor
actually invented the invention claimed.” Id.
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Here, although the Specification does not recite the claim term “exists
independently” in describing the radial elastomeric band, this is not
dispositive because “the [written] description requirement does not demand
any particular form of disclosure, . . . or that the specification recite the
claimed invention in haec verba.” Ariad, 598 F.3d at 1352. As discussed
above in connection with Rejection I, the Specification describes the radial
elastomeric band as a distinct element that is not a part of the balloon. See,
e.g., Spec. 7:25–26. In other words, the description of the balloon and radial
elastomeric band in the Specification is sufficient to reasonably convey to a
person of ordinary skill in the art that Appellant was in possession of an
intravascular catheter having a radial elastomeric band that exists
independently of the balloon (i.e., the radial elastomeric band is a distinct
element, and not part of the balloon).
Accordingly, we do not sustain the rejection of claims 23 and 24
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.

Rejection III – Obviousness based on Swanson,
Bencini, and Wang
Claims 1–8, 10, 12, 13, 15, 16, and 21–24
In contesting the rejection of claims 1–8, 10, 12, 13, 15, 16, and
21–24, Appellant presents arguments for independent claims 1 and 16
together, and does not separately argue dependent claims 2–8, 10, 12, 13, 15,
and 21–24. See Appeal Br. 9–13. We select independent claim 1 as
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representative, and claims 2–8, 10, 12, 13, 15, 16, and 21–24 stand or fall
with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv) (2018).
In rejecting claim 1, the Examiner finds that Swanson discloses an
intravascular catheter having most of the limitations of claim 1, including, in
relevant part, a balloon, a first electrode disposed on the balloon, and a first
elongate elastomeric member that is generally longitudinal. Final Act. 5–6.
The Examiner finds that “Swanson does not expressly disclose a balloon that
is molded comprising a plurality of elongated ridges, with the elastomeric
members and bands separate from the balloon and disposed between the
elongated ridges of the balloon.” Id. at 6. However, the Examiner finds that
Bencini teaches “that it was known in the art of balloon catheters to mold a
catheter balloon to include ridges corresponding to desired splines or ridges
(e.g. Col. 9, lines 7–37) and for the spline structure to be separate from the
balloon structure (e.g. Col. 12, lines 1–17).” Id. The Examiner determines
that it would have been obvious “to include the balloon ridges of Bencini in
the device of Swanson in order to provide the system with the predictable
results of a reliable balloon capable of providing stimulation.” Id.
The Examiner finds that “Swanson additionally does not disclose a
circumferential radial band.” Final Act. 6. However, the Examiner finds
that Wang teaches that “it was known in the art of balloon catheters to
include a circumferential radial band (e.g. Figure 3A).” Id. The Examiner
determines that it would have been obvious “to include the circumferential
member of Wang in the device of Swanson since such a modification would
provide the system with the predictable results of a more reliable means of
holding the balloon in the desired location.” Id. at 7.
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Appellant argues that helical coil 37 depicted in Figure 3A of Wang
does not constitute a “radial elastomeric band that circumferentially
surrounds the balloon around a longitudinal axis of the balloon,” as recited
in claim 1. Appeal Br. 10. Appellant asserts that “a helix surrounds a
longitudinal axis in three dimensions, and at no single point or plane along
the axis does the helix have a circumference that surrounds the axis.” Id.
Appellant asserts that, “[i]n contrast, the elastomeric band, as recited and as
plainly understood from the description in the specification, at the location at
which it is situated with respect to the balloon, defines a two-dimensional
plane in which the band circumferentially surrounds the balloon.” Id. (citing
Drawings, Fig. 5). According to Appellant, the Examiner “gives no weight
to the word ‘circumferentially,’ because there is no difference between
‘surrounds’ and ‘circumferentially surrounds’ with the Examiner’s
interpretation.” Id. at 11. We are not persuaded by Appellant’s argument.
The Examiner responds that “[t]he claim as currently filed does not
require that the ‘circumferentially surround[s]’ need be in two dimensions
instead of the three dimensions . . . taught by Wang.” Ans. 5 (quoting Adv.
Act. 2). The Examiner explains that “weight [was given] to the term
‘circumferentially’ by requiring that the elastomeric member surround the
balloon completely around the longitudinal axis.” Id. at 6. The Examiner
takes the position that “Figure 3A of Wang clearly shows an elastomeric
member that ‘circumferentially surrounds’ the longitudinal axis in three
dimensions.” Id. In this regard, Appellant does not persuasively refute the
Examiner’s interpretation that Wang’s helical coil 37 circumferentially
surrounds the balloon around its longitudinal axis. Moreover, although
claims are interpreted in light of the Specification, Appellant does not point
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to any disclosure in the Specification that would necessitate an interpretation
of “circumferentially surrounds” as precluding a three-dimensional shape,
such as Wang’s helical coil 37.
Appellant argues that “[m]odifying the balloon 22 of Swanson to
incorporate the helical coil 37 of Wang . . . would render the device of
Swanson unsuited for its intended purpose because the balloon 22 of
Swanson is ellipsoidal and has no cylindrical portion to accommodate the
helical coil of Wang.” Appeal Br. 12 (citing Swanson Fig. 12). Appellant
asserts that Wang’s helical coil 37 “would have most of its body hanging
freely from the ellipsoidal balloon 22 of Swanson rendering the balloon 22
unable to achieve the function discussed in Swanson of bulging beyond the
basket assembly 18 to bring the balloon 22 in direct contact with tissue.” Id.
(citing Swanson 7:52–61, Fig. 5); see also Reply Br. 16 (asserting that “a
helical coil as described in Wang is incompatible with a[n] ellipsoidal
balloon as described in Swanson”). This argument is not persuasive.
The Examiner responds that, in each of Swanson and Wang, the
“combination of elastomeric bands and balloons are used for the same
purpose of applying electrical stimulation at the same place the balloon is
located . . . .” Ans. 6. In this regard, Appellant does not persuasively refute
the Examiner’s position. Even if some adaptation of Wang’s coil would be
required to work with Swanson’s ellipsoidal balloon, Appellant does not
proffer factual evidence or persuasive technical reasoning to explain how
combining the balloon of Swanson with the helical coil of Wang in an
operable manner would be beyond the level of ordinary skill in the art. See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”); In
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re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of
references does not involve an ability to combine their specific structures.”).
Thus, we are unpersuaded by Appellant’s contention that combining Wang’s
helical coil with Swanson’s balloon, as proposed by the Examiner, would
render Swanson’s device inoperable or unsuitable for its intended purpose.
See Appeal Br. 12.
For the above reasons, Appellant does not apprise us of error in the
Examiner’s conclusion of obviousness with respect to claim 1. Accordingly,
we sustain the rejection of claim 1, and claims 2–8, 10, 12, 13, 15, 16, and
21–24 falling therewith, under 35 U.S.C. § 103(a) as unpatentable over
Swanson, Bencini, and Wang.
Claim 9
In rejecting claim 9, which depends from independent claim 1, the
Examiner finds that Wang teaches “a second radial band surrounding the
balloon (e.g. as shown in Figure 2E).” Final Act. 7; see also Ans. 7
(explaining that “Wang discloses that singular or double helix embodiments
can be combined with a balloon catheter system (e.g. Wang, Col. 25, lines
60–67)”).
In contesting the rejection of claim 9, Appellant initially relies on the
same arguments and reasoning that we found unpersuasive in connection
with the rejection of independent claim 1. Appeal Br. 13. Appellant also
argues that “the double helix of Wang is a pair of helical coils 27 for an
ablation catheter, and Wang does not teach or suggest combining this pair of
coils with a balloon.” Appeal Br. 13; see also Reply Br. 17 (asserting that
the cited portion of Wang does not support the Examiner’s finding). We are
not persuaded by this argument.
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Wang teaches an ablation catheter that includes helical coil 37
wrapped around balloon 33. Wang 10:49–53; see also id. at 8:20–22
(teaching that “the catheter tip may comprise a balloon around which is
wrapped a helical coil”). Wang also teaches that, “[i]n certain embodiments,
the catheter tip of the ablation catheter comprises a single helix; in others, it
is composed of double helix.” Id. at 25:53–55. In other words, Wang
teaches certain embodiments of the ablation catheter in which the balloon
may be wrapped by a helical coil, where the helical coil may be a single or
double helix. In light of this disclosure, Appellant’s argument does not
identify error in the Examiner’s finding, which is supported by a
preponderance of the evidence.
For the above reasons, Appellant does not apprise us of error in the
Examiner’s conclusion of obviousness with respect to claim 9. Accordingly,
we sustain the rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable
over Swanson, Bencini, and Wang.

Rejections IV and V – Obviousness based on Swanson, Bencini,
Wang, and one of Whayne and Demarais
With respect to Rejections IV and V, Appellant does not set forth any
additional substantive arguments separate from the arguments discussed
supra; instead adding only that Whayne and Demarais do not cure the
asserted deficiencies in Rejection III. See Appeal Br. 14 (asserting that
“none of Swanson, Bencini, Wang, Whayne, Demarais, individually, nor any
combination thereof, teaches or suggests, ‘. . . a [first] radial elastomeric
band that circumferentially surrounds the balloon around a longitudinal
axis of the balloon . . .,’ as recited by independent claims 1 and 16”). Thus,
for the same reasons that Appellant’s arguments do not apprise us of error in
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Rejection III, Appellant also does not apprise us of error in Rejections IV
and V.
Accordingly, we sustain the rejections under 35 U.S.C. § 103(a) of
claims 11, 18, and 19 as unpatentable over Swanson, Bencini, Wang, and
Whayne, and claim 20 as unpatentable over Swanson, Bencini, Wang, and
Demarais.

CONCLUSION
In summary:
Claims
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
23, 24 112, second
paragraph
Indefiniteness 23, 24
23, 24 112, first
paragraph
Written Description 23, 24
1–10, 12, 13,
15, 16, 21–24
103(a) Swanson, Bencini,
Wang
1–10, 12,
13, 15, 16,
21–24

11, 18, 19 103(a) Swanson, Bencini,
Wang, Whayne
11, 18, 19
20 103(a) Swanson, Bencini,
Wang, Demarais
20
Overall
Outcome
1–11, 15,
16, 18–24

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).

AFFIRMED