BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Jun 25, 2020

2019006525 (P.T.A.B. Jun. 25, 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.
14/549,121 11/20/2014 ROBERT N. SQUIRE 8150BSC0243 6995
121974 7590 06/25/2020
KACVINSKY DAISAK BLUNI PLLC
2601 Weston Parkway
Suite 103
Cary, NC 27513
EXAMINER
FOWLER, DANIEL WAYNE
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
06/25/2020 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 ROBERT N. SQUIRE, JEFFREY S. LINDQUIST,
DEREK C. SUTERMEISTER, PATRICK A. HAVERKOST, and
TIMOTHY A. OSTROOT

Appeal 2019-006525
Application 14/549,121
Technology Center 3700
____________

Before MICHAEL L. HOELTER, JEREMY M. PLENZLER, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.

HOELTER, 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 1–8 and 10–19, which constitute all the
claims pending in this application. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. We understand the real party in interest is “Boston
Scientific Scimed, Inc.” Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The disclosed subject matter “pertains to medical devices, and
methods for manufacturing medical devices. More particularly, the present
disclosure pertains to medical devices for sympathetic nerve ablation.”
Spec. 1:10–12. Apparatus claim 1, and method claims 13 and 17, are
independent. Claim 1 is representative of the claims on appeal and is
reproduced below.
1. A medical device for sympathetic nerve ablation,
comprising:
a catheter shaft;
an expandable balloon coupled to the catheter shaft, the
balloon being capable of shifting between an unexpanded
configuration and an expanded configuration;
wherein the balloon includes a first layer and a second
layer;
wherein the first layer includes a convertible circuit;
wherein the convertible circuit is defined along an etched
region of the first layer;
an electrode and circuitry metal positioned within the
etched region and in electrical contact with the convertible
circuit; and
an insulating layer disposed over the circuitry metal but
not over the electrode.
Appeal Br. 19 (Claims Appendix).
EVIDENCE
Name Reference Date
Corbett, III et al.
(“Corbett”)
US 5,515,848 May 14, 1996
Stern et al. (“Stern”) US 5,562,720 Oct. 8, 1996
Levin US 6,562,035 B1 May 13, 2003
Tittle US 7,514,643 B1 Apr. 7, 2009
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Perry et al. (“Perry”) US 2011/0130708 A1 June 2, 2011
REJECTIONS
Claims 1–8, 10–15, and 17–19 are rejected under 35 U.S.C. § 103 as
unpatentable over Stern, Tittle, Corbett, and Levin.
Claim 16 is rejected under 35 U.S.C. § 103 as unpatentable over
Stern, Tittle, Corbett, Levin, and Perry.
ANALYSIS
The rejection of claims 1–8, 10–15, and 17–19
as unpatentable over Stern, Tittle, Corbett, and Levin
The rejection of claim 16
as unpatentable over Stern, Tittle, Corbett, Levin, and Perry
Appellant argues claims 1–8, 10–15, and 17–19 together. See Appeal
Br. 7–14. Appellant also separately addresses claims 13–19 together. See
Appeal Br. 15–17. Appellant does not separately argue the different
rejection of claim 16, but merely addresses the additional reference cited
(i.e., Perry) stating that this reference does “not make up for the above-noted
deficiencies.” Appeal Br. 14. Accordingly, we select independent claims 1
and 13 for review, with the remaining claims standing or falling therewith.
See 37 C.F.R. § 41.37(c)(1)(iv).
Claim 1
The Examiner primarily relies on Stern for disclosing the structure
recited in claim 1 including the recited conductive parts. See Final Act. 2.
The Examiner specifically relies on Stern for teaching “that the conductive
parts of the device may be formed by any known method (col. 8 lines 17-28,
col. 14 lines 29-42).” Final Act. 2–3. To be clear, the Examiner’s
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paraphrasing of “any known method” is not technically accurate (but close)
because Stern actually states “[t]he expandable balloon or bladder 10 with its
electrodes can be manufactured in a variety of ways” and thereafter provides
examples of such “ways,” and concludes this listing “and the like.” Stern
8:17–28. Thus, while “any” may be too broad an interpretation, it is clear
that Stern expresses the ability to employ a number of known methods by
which to make the device. See also Ans. 7 (“Stern still points broadly to
other methods beside those listed.”). Hence, Appellant’s attempt to restrict
Stern’s teachings to only those methodologies explicitly identified therein is
too restrictive an interpretation of Stern’s teachings. See Appeal Br. 10;
Reply Br. 10–11, 14–15.
The Examiner relies on the teachings of Tittle as simply being “one of
numerous references that describe in broad terms how LDS [laser direct
structuring] works.”2 Final Act. 3; see also Ans. 5 (“Tittle was cited
primarily because of the robust description of how LDS actually works.”).
Thus, based on Stern’s teaching above, the Examiner reasons that it would
have been obvious to a skilled person to employ Tittle’s method of
manufacture (i.e., LDS) so as “to produce the predictable result of a balloon
with conductive elements.” Final Act. 3; see also Ans. 3 (“Examiner
contends using a known method to make a known structure that produces
predictable results is in fact obvious.”). However, the Examiner recognizes
that neither Stern nor Tittle specifically address the limitation that the circuit

2 The Examiner also refers to Kupferschmid as being another reference
describing LDS. See Final Act. 6. Appellant recognizes that Kupferschmid
is “like Tittle” and “analogous to Tittle” in this regard. Appeal Br. 10;
Reply Br. 12. However, it should be noted that Kupferschmid is not
expressly relied upon by the Examiner to reject claim 1.
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“is defined along an etched region” of the balloon because these two
references are silent as to “the relationship between the outer surface of the
electrode and the outer surface of the balloon.” Final Act. 3.
The Examiner relies on Corbett for disclosing that “electrodes may be
formed below, flush with, or above a dielectric material” (i.e., within an
“etched” region). Final Act. 4 (referencing Corbett Figs. 11–13). Corbett
specifically teaches using a laser to form openings in a dielectric and that
these openings may be either partly filled, filled flush, or filled so as to form
a protrusion with “suitable deposits of metal having desired conductivity.”
Corbett 8:10–49. Thus, based on Corbett, the Examiner reasons that it
would have been obvious “to provide the electrode surface of Stern-Tittle at
any particular relationship with the balloon surface,” i.e., recessed, flush, or
protruding. Final Act. 4. Finally, the Examiner relies on Levin for
disclosing “an electrosurgical device which uses insulation to control which
portion of a conductor emits energy” and reasons that it would have been
obvious to combine the above teachings with Levin “to allow the device to
emit energy in a desired manner.” Final Act. 4.
Appellant disputes the Examiner’s combination of Stern and Tittle on
the basis of non-analogous art and hindsight. Appeal Br. 8, 12; Reply Br. 7,
16. Appellant argues that a skilled person “would not have been motivated”
to employ Tittle’s LDS process pertaining to a “rigid PC board” in
conjunction with Stern’s “flexible polymer film balloon.” Appeal Br. 7, 8;
Reply Br. 6, 7. Hence, Stern and Tittle (a) are “not from the same field of
endeavor” and (b) address problems “clearly isolated from one another.”
Appeal Br. 8; Reply Br. 7. Thus, as per Appellant, the Examiner relied on
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“the hindsight provided by the present disclosure.” Appeal Br. 8; Reply
Br. 7.
Regarding this rigid/flexible difference raised by Appellant, the
Examiner states, “Applicant has not shown that applying [the] teachings of
one type to the other would be out of reach of the person of ordinary skill in
the art.” Final Act. 7. Further, “the cited prior art nowhere says ‘these
methods are only applicable to rigid structures’,” and the Examiner notes
that “the illustrative methods in Stern of putting an electrode on a balloon
(vapor deposition in particular) are well known for use on rigid structures
too.” Ans. 8; see also Ans. 5–6 (discussing Breitter’s teaching of the
functional equivalence of LDS and vapor deposition as supporting
Examiner’s conclusion that “one reading Stern would recognize that the
methods disclosed, particularly vapor deposition, are known for use in other
types of devices”). Appellant proffers no evidence explaining why Tittle’s
LDS methodology is not suitable for use with Stern’s flexible material. Ans.
8 (“Appellant has not offered any evidence or argument that the teachings of
the various references are not applicable to each other.”).
Instead, Appellant responds, “Appellant respectfully submits that
[this] would not” be the case. Appeal Br. 9; Reply Br. 8. Appellant states,
“Appellant is arguing, inter alia, that it would not be prima facie obvious to
modify Stern based on the teachings of Tittle.” Ans. 9; see also id. at 11, 21.
These rejoinders by Appellant, sans any evidence in support of Appellant’s
argument, are not sufficient to overcome a prima facie finding of
obviousness. In other words, Appellant does not dispute the Examiner’s
finding that one of the methodologies described in Stern (i.e., vapor
deposition) can also be employed on a rigid structure (see Ans. 8).
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However, Appellant fails to explain or proffer evidence as to how the
reverse is not also true, i.e., a methodology employed on a rigid structure
(i.e., Tittle’s LDS process) is likewise suitable for use on a flexible structure
such as Stern’s balloon especially in light of Stern’s teaching concerning the
variety of ways that the electrodes can be manufactured. See Stern 8:17–28.
Instead, Appellant contends merely that “it is self-evident that one clearly
would not be motivated to consider teachings directed to circuits from any
other area of circuit manufacturing.” Ans. 9; see also id. at 10, 14.
We have been instructed that “attorney argument [is] not the kind of
factual evidence that is required to rebut a prima facie case of obviousness.”
In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Hence, this
rigid/flexible distinction made by Appellant is not persuasive the Examiner
erred in combining Tittle’s LDS process with Stern’s balloon.3
More specific to Appellant’s “field” prong of the analogous art
argument discussed above, the Examiner notes that “LDS technology was
generally understood to be useful in medical fields” and thereafter references
Kupferschmid, a previously cited reference, that “shows a medical device
which uses LDS to construct an electrode.”4 Ans. 5. Further, Stern is also
directed to the use of a balloon catheter within a patient, similar to
Appellant’s device. See Stern generally.

3 In Appellant’s Answer, Appellant appears to be focusing specifically “on
what the cited references teach” (Ans. 14) to the exclusion of the capabilities
of a person skilled in the art. As is well-known, “[a] person of ordinary skill
is also a person of ordinary creativity, not an automaton.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 421 (2007).
4 Kupferschmid was “cited in the rejection dated 11/20/18.” Ans. 5.
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Regarding the problem addressed by Appellant, Appellant states “the
problems being solved by the inventor vis-a-vis the claimed invention
include the formation of an electrode and circuitry metal that is positioned
within an etched region on a medical device surface.” Appeal Br. 12; Reply
Br. 17. What is noteworthy from Appellant’s description of the problem
solved by the inventor is the lack of any reference whatsoever to applying
LDS methodology to a flexible surface. Accordingly, we are not persuaded
the Examiner’s combination of Stern and Tittle is a combination of non-
analogous art.
As to Appellant’s hindsight argument, Stern was cited for teaching
that a variety of different methodologies may be used (Stern 8:17–18), and
that Tittle’s LDS methodology was simply one such process for a skilled
person to consider (see Final Act. 3). Hence, Appellant’s contention that
one skilled in the art would not have been motivated to combine Stern and
Tittle “given the markedly different needs and problems faced by Stern and
Tittle” (Appeal Br. 9–10; Reply Br. 9), is not persuasive of Examiner error
on this point.
Appellant further contends that “just because a given method of
manufacturing circuits may have particular advantages and disadvantages,
doesn’t mean that this would lead one of ordinary still in the art to the
claimed invention.” Appeal Br. 10; see also Reply Br. 14 (“The cited art,
however, does not disclose or suggest that LDS [] has any particular
advantages.”). On this point, the Examiner responds that a skilled person
“would be motivated to consider a wide range of circuit construction
methods depending on the particular advantages to be sought or the
particular disadvantages to be avoided.” Ans. 6. This would particularly be
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the case “since Stern specifically suggests various construction methods are
possible.” Ans. 6. Appellant’s contentions above are not persuasive of
Examiner error on this point.
Of further interest in the matter before us is Appellant’s statement that
“Appellant has in fact used LDS in a novel fashion to form a novel device.”
Appeal Br. 11. However, “apparatus claims cover what a device is, not what
a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d
1464, 1468 (Fed. Cir. 1990). The Examiner further clarifies that “novelty is
not the only criteria for patentability; with respect to the prior art, the device
must also be non-obvious.” Ans. 9. We are not persuaded of Examiner
error on this point.
Appellant thereafter addresses Stern as failing to teach or suggest the
use of circuitry “positioned within an etched region of a device as claimed.”
Appeal Br. 13; Reply Br. 18. Appellant also argues that Tittle “is clearly
remote from the formation of an electrode and circuitry metal positioned
within an etched region.” Appeal Br. 13; Reply Br. 18. In both cases,
Appellant is arguing the art individually because the Examiner relied on
Corbett for teaching deposition into an etched region, not Stern or Tittle.5
See Final Act. 3–4. Hence, these arguments are not persuasive of Examiner
error.

5 Regarding the issue of etching, Appellant contends, “there is no suggestion
in Tittle that the LDS process could be used to form such an etched region”
(Reply Br. 21), but Appellant does not dispute the Examiner’s statement,
regarding Tittle, that “to some degree, etching and depositing metal are
intrinsic parts of LDS.” Reply Br. 20; Ans. 11–12 (referencing Tittle 5:25–
43).
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Regarding Corbett, Appellant seeks to distinguish this reference
stating, “the use of a laser to provide an active electrode site by ablating the
dielectric material coatings of fine wires as described in Corbett (see, e.g.,
col. 4, lines 1–4 and 19–26), is remote from the present invention.” Appeal
Br. 14, n.1; Reply Br. 19, n.1. However, as mentioned above, Corbett was
relied on for teaching the etching of material, and Appellant’s contention
above regarding Corbett’s ablating action would seem to confirm that
Corbett indeed teaches etching of the material. We thus conclude that the
Examiner did not err by relying on Corbett for teaching the etching of a
surface for subsequent filling by “metal having desired conductivity.”
Corbett 8:34–49.
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claim 1 as being obvious over Stern, Tittle,
Corbett, and Levin.
Claim 13
Appellant addresses method claim 13 focusing on Tittle’s teaching of
producing “conductive paths on the top of a PC board,” and that “[t]his is
clearly remote from the formation of an electrode and circuitry metal
positioned within an etched region as claimed.” Appeal Br. 15; Reply Br.
22. This contention is not persuasive because the Examiner relied on
Corbett for teaching the formation of circuitry “within an etched region” as
stated, not Tittle. See Final Act. 3–4. Further, Appellant’s contention that
“forming the conductive paths of Tittle within an etched region would render
the electrical contact required by Tittle more difficult” (Appeal Br. 15; see
also Reply Br. 22) is not persuasive. This is because Appellant does not
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explain how the combination of Tittle and Corbett, even if “more difficult,”
renders that combination non-obvious.
Regarding Corbett specifically, Appellant contends that Corbett “does
not make up for the above noted deficiencies in Stern[ and] Tittle.” Appeal
Br. 16; Reply Br. 23. Appellant further contends: “The use of a laser to
provide an active electrode site by cutting openings in a dielectric material
to expose conductive material as described in Corbett (see, e.g., col. 4, lines
1-4 and 19-26), is remote from claims 13 and 17.” Appeal Br. 16; Reply
Br. 23. Appellant provides no further explanation as to why Corbett’s
method of etching might be “remote from” Appellant’s recited method of
etching. As such, Appellant’s arguments are not persuasive the Examiner
erred when relying on Corbett for teaching etching.
Addressing Levin and Perry (claim 16), Appellant simply contends
that these references “do not make up for the above-noted deficiencies in
Stern, Tittle, [] and Corbett.” Appeal Br. 17; Reply Br. 24.
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claims 1–8, 10–15, and 17–19 as being
obvious over Stern, Tittle, Corbett, and Levin. We are further not persuaded
the Examiner erred in rejecting claim 16 as being obvious over Stern, Tittle,
Corbett, Levin, and Perry.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–8, 10–
15, 17–19
103 Stern, Tittle,
Corbett, Levin
1–8, 10–
15, 17–19

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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
16 103 Stern, Tittle,
Corbett, Levin,
Perry
16
Overall
outcome
1–8, 10–
19

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

AFFIRMED