Martin R. Willard et al.

Patent Trials and Appeals Board

Oct 31, 2019

14327154 - (D) (P.T.A.B. Oct. 31, 2019)

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.
14/327,154 07/09/2014 MARTIN R. WILLARD 8150BSC0223 4918
121974 7590 10/31/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
EXAMINER
OUYANG, BO
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/31/2019 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 and
PATRICK A. HAVERKOST
____________________

Appeal 2018-003144
Application 14/327,154
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, LEE L. STEPINA, and
BRENT M. DOUGAL, Administrative Patent Judges.

DOUGAL, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Appellant appeals under 35 U.S.C. § 134 from a Final rejection of
claims 1, 3, 4, 6, 8–14, 16–19, and 21–25.1 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(a). Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Br. 3.
Appeal 2018-003144
Application 14/327,154

2
CLAIMED SUBJECT MATTER
The claims are directed to devices and systems for nerve modulation.
Claims 1, 13, and 19 are independent. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. An intravascular nerve modulation system, comprising:
an outer elongate shaft having a proximal end, a distal end,
and a lumen extending therebetween;
an inner elongate shaft having a proximal end and a distal
end;
an expandable basket having a proximal end and a distal
end, the proximal end of the expandable basket affixed adjacent
to the distal end of the outer elongate shaft;
an electrode assembly that comprises a flexible circuit
comprising one or more electrodes affixed adjacent to the
expandable basket;
an inner cover disposed over an inner surface of the
expandable basket; and
an outer cover disposed over the outer surface of the
expandable basket;
wherein the flexible circuit is disposed between the inner
cover and the outer cover; and
wherein the system does not comprise an inflation lumen.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:

Hassett US 6,251,109 B1 June 26, 2001
Flaxmeier
Steinke
US 2006/0129143 A1
US 2008/0161801 A1
June 15, 2006
July 3, 2008
Appeal 2018-003144
Application 14/327,154

3
REJECTIONS2
Claims 1, 3, 4, 6, 8–14, 16–19, and 22–24 are rejected under 35
U.S.C. § 103 as being unpatentable over Steinke and Flaxmeier.
Claims 21 and 25 are rejected under 35 U.S.C. § 103 as being
unpatentable over Steinke, Flaxmeier, and Hassett.

OPINION
Claim 1 requires, inter alia: an expandable basket and a flexible
circuit which are both sandwiched between an inner cover and an outer
cover. The Examiner finds that Steinke teaches the features of the
independent claims, except for the inner cover. Final Act. 3–4. The
Examiner finds that Flaxmeier discloses a device similar to Steinke that has
an inner cover, namely filter membrane 40. Id. at 4. The Examiner
determines that it would have been obvious to modify Steinke to include
Flaxmeier’s filter membrane to “allow for the inner cover to filter and trap
particles during treatment, to prevent these particles from circulating in the
blood stream.” Id. at 5.3 Independent claims 13 and 19 include similar
limitations and are rejected under this same basis.
Appellant argues persuasively that “the presence of an outer cover
(barriers 66, 68) [in Steinke] over the inner filter membrane [as modified by
Flaxmeier] would block the flow of fluid from passing through the filter
membrane and defeat the purpose of the filter membrane, which is to act as a
filter, by blocking fluid from reaching the filter.” Appeal Br. 12.

2 The Advisory Action indicates that the rejection under 35 U.S.C. § 112,
second paragraph was overcome. Adv. Act. 1.
3 The Examiner has an alternative rejection of claims 1 and 6 that ultimately
also relies on the aspects of Steinke and Flaxmeier highlighted.
Appeal 2018-003144
Application 14/327,154

4
Concerning the purpose of the barriers 66, 68, Steinke teaches:
Barriers 66, 68 inhibit any ablation debris and gases generated
adjacent electrodes 50 from traveling within the body lumen
beyond catheter 12. Barriers 66, 68 also allow an at least
partially isolated ablation environment to be established within
the body lumen, for example, by replacing blood within a blood
vessel with a more advantageous fluid environment for limiting
charring of the electrodes and the like.

Steinke ¶ 84. This is best shown in annotated Figure 10B, reproduced
below.

Annotated Figure 10B shows Steinke’s ablation device in a blood vessel.
As can be seen above, the barriers 66, 68 can create a pocket or
isolated environment where the electrodes contact the blood vessel. In this
way any debris from the ablation can be contained and removed. It is
unclear what purpose Flaxmeier’s filter inside of Steinke’s barriers would
serve. The Examiner states that the reason for adding the filter is “to prevent
. . . particles [resulting from the treatment] from circulating in the blood
stream.” Final Act. 5. In Flaxmeier, the filter is positioned in the blood flow
and prevents particles from being carried off with the blood. Flaxmeier
¶ 55. However, this purpose is already served by the barriers 66, and 68, as
Appeal 2018-003144
Application 14/327,154

5
well as by the additional barriers mentioned by Steinke (Steinke ¶ 84) and
cited by the Examiner (Ans. 2). If Steinke were modified to include a filter
inside of the barriers, the filter would not serve the same purpose and would
in fact be prevented by the barriers from functioning as taught by Flaxmeier
as the filter would be inside of the barriers, which would prevent the filter
from filtering debris from blood flow. Thus, the Examiner’s reasoning for
the proposed combination of the teachings of Steinke and Flaxmeier is not
supported by rational underpinnings.
For these reasons we do not sustain the Examiner’s rejections.
DECISION SUMMARY
In summary:

Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 3, 4, 6, 8–14,
16–19, 22–24
103 Steinke, Flaxmeier 1, 3, 4, 6, 8–14,
16–19, 22–24
21, 25 103 Steinke, Flaxmeier,
Hassett
21, 25
Overall Outcome 1, 3, 4, 6, 8–14,
16–19, 21–25

REVERSED