Martin R. Willard et al.

Patent Trials and Appeals Board

Oct 2, 2020

14516014 - (D) (P.T.A.B. Oct. 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.
14/516,014 10/16/2014 MARTIN R. WILLARD 8150BSC0207 3471
121974 7590 10/02/2020
KACVINSKY DAISAK BLUNI PLLC
2601 Weston Parkway
Suite 103
Cary, NC 27513
EXAMINER
DELLA, JAYMI E
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/02/2020 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):
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 MARTIN R. WILLARD, DEREK C. SUTERMEISTER,
KENNETH R. LARSON, TIMOTHY A. OSTROOT, and
PATRICK A. HAVERKOST
___________

Appeal 2019-001296
Application 14/516,014
Technology Center 3700
____________

Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
JEREMY M. PLENZLER, Administrative Patent Judges.

REIMERS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision to reject claims 1–6, 8, and 11–23. Claims 7, 9, and 10 have been
canceled. 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. Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Brief (“Appeal Br.”) 3, filed Sept. 4, 2018.
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CLAIMED SUBJECT MATTER
The claimed subject matter “generally pertains to percutaneous and
intravascular devices for nerve modulation and/or ablation.” Spec. 1:11–12,
Fig. 2. Claims 1, 13, and 18 are independent.
Claim 1 is illustrative of the claimed subject matter and recites:
1. A medical device, the medical device comprising:
an elongate shaft having a proximal end region, a
distal end region, and a lumen extending therebetween;
an expandable member coupled to the distal end
region of the elongate shaft, wherein the expandable
member is an inflatable cylindrical balloon;
one or more electrical conductors extending from
the proximal end region to the expandable member, the
one or more electrical conductors having a distal end
region secured directly to an outer surface the expandable
member; and
one or more energy delivery regions positioned on
the expandable member and coupled to the one or more
electrical conductors;
wherein the one or more energy delivery regions are
formed from a distal portion of the one or more electrical
conductors;
wherein the one or more electrical conductors are
each at least partially coated with an insulator[;]
wherein the one or more energy delivery regions are
defined by one or more regions of the one or more
electrical conductors that are free of the insulator; and
wherein at least a portion of the one or more regions
of the one or more electrical conductors that are free of the
insulator is wound in a serpentine manner.

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REJECTIONS2
I. Claims 1–6, 11, 13, 21, and 22 stand rejected under 35 U.S.C. § 103
as unpatentable over Clayman (US 5,779,698, issued July 14, 1998) and
Stern (US 5,713,942, issued Feb. 3, 1998).
II. Claims 8 and 14–16 stand rejected under 35 U.S.C. § 103 as
unpatentable over Clayman, Stern, and Salahieh (US 2010/0204560 A1,
published Aug. 12, 2010).
III. Claims 12 and 17 stand rejected under 35 U.S.C. § 103 as
unpatentable over Clayman, Stern, and Dimmer (US 2012/0310233 A1,
published Dec. 6, 2012).
IV. Claims 18–20 and 23 stand rejected under 35 U.S.C. § 103 as
unpatentable over Clayman, Stern, Salahieh, and Dimmer.

ANALYSIS
Rejection I
Claims 1–6, 11, 13, 21, and 22
Independent claim 1 is directed to a medical device including one or
more energy delivery regions defined by one or more regions of one or more
electrical conductors that are free of the insulator, “wherein at least a portion
of the one or more regions of the one or more electrical conductors that are

2 We note the Examiner has objected to a number of the claims for
informalities. Final Office Action (“Final Act.”) 2–4, dated Feb. 7, 2018. In
the Advisory Action (“Advisory Act.”), dated April 24, 2018, the Examiner
indicates that Appellant’s “amendments are sufficient to overcome the claim
objections set forth in the [final] office action. Accordingly, the amendment
is entered as it is deemed to place the application in better form for appeal.”
Advisory Act. 1, 2.
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free of the insulator is wound in a serpentine manner.” Appeal Br. 15
(Claims App.).
The Examiner finds that Clayman discloses the medical device of
claim 1 substantially as claimed except “Clayman fails to disclose at least a
portion of the one or more regions of the one or more electrical conductors
that are free of the insulator is wound in a serpentine manner.” Final Act. 6.
The Examiner looks to the teachings of Stern for this limitation. See id. In
particular, the Examiner finds that Stern “disclose[s] a medical device
comprising one or more energy delivery regions that are the distal end of one
or more wire conductors (170, 172) on a balloon (14) that are wound in a
serpentine manner.” Id. The Examiner reasons that a skilled artisan would
have been motivated “to modify the invention of [Clayman] such that at
least a portion of the one or more regions of the one or more electrical
conductors that are free of the insulator is wound in a serpentine manner in
order to provide the benefit of promoting a uniform heating of the area as
taught by Stern.” Id. (citing Stern 4:35–57, 6:61–67, Fig. 9).
In the Answer, the Examiner further clarifies that “the proposed
modification is to modify the circular electrode pads (100) of Clayman such
that the electrode surface area is a serpentine electrode rather than a circular
electrode” and that such a modification “provides the benefit/advantage of
presenting a uniform current density across the electrode area in view of the
teachings of Stern, thus more uniformly treating tissue across the electrode
area by cutting, vaporizing, incising, removing or other alteration across the
electrode area.” Ans. 6;3 see also id. at 6–7 (“Stern clearly teaches the

3 Examiner’s Answer (“Ans.”), dated Oct. 5, 2018.
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benefit/advantage to modify an electrode pad (100) of Clayman with a
serpentine electrode pattern to present a uniform current density across the
electrode area in view of the teachings of Stern, thus more uniformly treating
tissue across the electrode area of Clayman.”).
Appellant contends that “promotion of uniform heating as taught in
Stern is antithetical to the sharply defined cutting of Clayman and the
proposed modification would render the prior art being modified (Clayman)
unsatisfactory for its intended purpose.” Reply Br. 8;4 see also Appeal Br.
10, 12. According to Appellant, “uniform current density for uniform
heating as taught by Stern is at cross[-]purposes with the high current
density for cutting as desired by Clayman.” Reply Br. 14; see also id. at 11
(“[E]qualizing current density across a surface is at cross-purposes with
creating high current density for purposes of cutting, vaporizing, incising,
etc.”); Clayman 1:26–28 (“With a low current density, heat is generated but
no cut is achieved. With a high current density, fast cutting occurs.”).
In support of this argument, Appellant explains that “when Stern
discusses equalizing current density across the surface area of the electrode
such that uniform heating is achieved,” “this is [in] conjunction with a large
surface area electrode that is designed [to] provide equalized current density
over the entire surface of an endometrium in order to uniformly provide
heating of the endometrium.” Reply Br. 11; see also id. at 7–8, 9 (“Stern’s
reason for selecting a serpentine electrode pattern is that it allows uniform
heating over the entire surface of the device and thus allows [radio
frequency (RF)] current to be passed through the entire surface of the

4 Reply Brief (“Reply Br.”), filed Nov. 28, 2018.
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endometrium in order to destroy the cells of the endometrial lining.”);
Appeal Br. 11.
In contrast to Stern, Appellant explains that Clayman discloses “an
angioplasty catheter for increasing the patency blood vessels, which offers
many advantages, including the fact that cutting of the vessel is
accomplished in a very controlled, limited, atraumatic and accurate
procedure, which results in a larger diameter for the vessel without the
excessive injury and trauma which invites restenosis” and “a radiofrequency
cutting element is preferred for a number of reasons, including the fact that
cutting can be very sharply defined leading to a clean incision.” Reply Br.
10; see also Appeal Br. 11–12. Based on these arguments, Appellant
concludes that “the function of the electrode [of Clayman] would be changed
from a role of a precise cutting element that minimizes tissue trauma to the
role of an element that causes uniform tissue destruction.” Reply Br. 14; see
also Appeal Br. 13.
Appellant has the better position here. Clayman discloses that
“[c]urrent density is . . . dependent upon the area the active cutting electrode
presents to the patient’s tissue. The smaller this area the higher the current
density.” Clayman 1:31–34 (emphasis added); see also id. at 3:44–55 (“A
printed circuit is disposed on the exterior surface of the balloon and includes
a plurality of discrete areas of electrically conductive material. . . . the
discrete areas can be energized to electrosurgically remove the material
defining the body conduit.” (emphasis added)). Clayman further discloses
that discrete pads 100 formed on exterior surface 95 of balloon 75 may be
covered with a coating 115 of insulation, “coating 115 can be cut to form a
narrow slit 117 over each of pads 100,” and “[t]he area of th[e] slit 117 can
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be controlled to reduce the exposure of the associated pad 100 thereby
increasing the current density at each of the slits 117.” Clayman 10:47–52
(emphases added), Figs. 9, 12;5 see also id. at 9:66–10:1; id. at Abstract
(“An overlying insulation layer can be provided with a slot to limit the
exposure of the conductor to the obstruction thereby increasing the current
density in the electrosurgical procedure.” (emphases added)).
In contrast, Stern discloses that a radio frequency (RF) “current is
passed through substantially the entire surface of the endometrium” and the
invention “provide[s] electrodes having a specific configuration . . . so that
uniform heating is achieved over the entire electrode surface . . . thereby
creating a uniform density of edges and equalizing the current density across
the [entire] surface area of the electrode.” Stern 2:5–7 (emphasis added); see
also id. at 2:29–36 (emphasis added); id. at Abstract.
Stern also discloses that “[u]niform heating is . . . obtained by
extending the electrodes in a pattern of lines, such as the serpentine pattern
structure” of Figure 9 and “[a]s a result of th[is] kind[] of construction[], the
treatment method of the present invention as well as the electrode elements

5 We acknowledge that the Examiner cites to Figure 12 of Clayman. See
Final Act. 4–5. However, Clayman discloses that in the embodiment
illustrated in Figures 12–14, “structural elements which are similar to those
previously discussed are designated by the same reference numeral followed
by the lower case letter ‘a’.” Clayman 10:66–11:3. We also note that Figure
12 of Clayman illustrates discrete pads 100a, insulation layer (coating) 115a,
and slit 117a. See id. at 10:66–11:16, Fig. 12. Additionally, we could not
find any discussion of “pads 100[a] [being] free from insulation layer 115a”
at column 11, lines 5 through 43, of Clayman. See Final Act. 5; see also
Clayman 11:15–16 (“The insulation layer 115a can be similarly printed over
the pads 100a and the leads 124.”)
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provide an increased current density as a function of the ‘electrode edge
length’ available for heating.” Stern 7:50–56, Fig. 9; see also id. at 6:61–67.
Based on the disclosures of Clayman and Stern, we agree with
Appellant that these references appear to be at cross-purposes with one
another. In particular, Clayman describes increased current density via
limited exposure of the electrode current across a small/discrete area of the
electrode; whereas, Stern describes increased current density via more
uniform exposure of the electrode current across the entire surface area of
the electrode.
Additionally, Clayman discloses that “[v]aporizing, cutting, incising.
removing or other altering of the material, such as the plaque 80, is
accomplished by the arcing of radiofrequency current from the electrode,
such as the pad 100 to the material” and “[t]o facilitate this arcing, it is
desirable that the pad 100 not be placed in direct touching contact with the
material, but rather that a slight gap be maintained between the pad 100 and
the tissue.” Clayman 10:53–59 (emphases added); see also id. at 1:55–57
(“The current utilized in electrosurgical cutting is in the radiofrequency
range and operates by jumping across an air gap to the tissue.”). Further,
Stern discloses that “[e]lectric current flowing through the tissue causes
resistive heating” and “[t]he power density diminishes with distance from
[the tissue to] the electrode.” Stern 4:18–20.
As such, even assuming for the sake of argument that the teachings of
Clayman and Stern could be combined as proposed by the Examiner, the
“uniform current density” of the serpentine pattern of Stern would appear to
decrease/diminish, not increase, the current density of Clayman, as Clayman
requires that a slight gap be maintained between pad 100 and the tissue and
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as taught by Stern, current density decreases/diminishes with distance
between the tissue and the electrode. Clayman also discloses, as expressed
above, that “[w]ith a low current density, heat is generated but no cut is
achieved. With a high current density, fast cutting occurs.” Clayman 1:26–
28. Thus, based on the above teachings of Clayman and Stern, as heat is
generated but no cut is achieved with low/decreased current density, we do
not agree with the Examiner’s finding that “a ‘uniform’ clean cut/incision
would be achieved in the modified device of Clayman in view of the
teachings of Stern.” Ans. 5 (emphasis added).
Moreover, as Clayman describes “electrosurgical procedures” and
recites that “in the case of electrosurgical angioplasty, cutting of the vessel is
accomplished in a very controlled, limited, atraumatic, and accurate
procedure” (Clayman 2:51–53), we fail to see and the Examiner fails to
explain adequately how modifying the circular electrode pads of Clayman to
include the uniform current density of the serpentine pattern of Stern would
lead to “a more precise” cut by the modified Clayman device. See Ans. 7;
see also Reply Br. 11–12 (“[T]he device of Clayman [is] designed to
perform sharply defined cutting and would not be expected to benefit from
uniform heating[/current density] as taught in Stern.”); id. at 7, 10; Appeal
Br. 9, 11; Clayman 1:66–2:2.
Similar to independent claim 1, independent claim 13 is directed to a
medical device and recites “at least a portion of the one or more wire
conductors is wound in a serpentine manner.” See Appeal Br. 17 (Claims
App.). The Examiner relies on the same unsupported findings in Clayman
and Stern as those discussed above in support of the rejection of claim 1.
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See Final Act. 4–6, 7–8. As such, the Examiner’s findings with respect to
Clayman and Stern are deficient for claim 13 as well.
Accordingly, for the above reasons, we do not sustain the Examiner’s
rejection of claims 1–6, 11, 13, 21, and 22 as unpatentable over Clayman
and Stern.
Rejections II–V
Claims 8, 12, 14–20, and 23
Independent claim 18 is directed to a medical device and recites
similar claim language as that discussed above for claim 1. Appeal Br. 15,
18 (Claims App.). The Examiner relies on the same unsupported findings in
Clayman and Stern for Rejections II–V as those discussed above for
Rejection I. See Final Act. 8–13. The Examiner does not rely on the
teachings of Salahieh or Dimmer to remedy the deficiencies of Clayman and
Stern.
Accordingly, for reasons similar to those discussed above for
Rejection I, we do not sustain Rejections II–V.

CONCLUSION
In summary:

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1–6, 11, 13, 21,
22
103 Clayman,
Stern
1–6, 11, 13,
21, 22
8, 14–16 103 Clayman,
Stern,
Salahieh
8, 14–16
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Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
12, 17 103 Clayman,
Stern,
Dimmer
12, 17
18–20, 23

103 Clayman,
Stern,
Salahieh,
Dimmer
18–20, 23
Overall
Outcome
1–6, 8, 11–23

REVERSED