Northwestern University

Patent Trials and Appeals Board

Feb 21, 2020

13954265 - (D) (P.T.A.B. Feb. 21, 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.
13/954,265 07/30/2013 David M. Mahvi 47690-703.201 8103
21971 7590 02/21/2020
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
OUYANG, BO
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
02/21/2020 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):
patentdocket@wsgr.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID M. MAHVI, DANIEL P. MCCARTHY,
TYLER R. WANKE, and BRIAN J. ROBILLARD

Appeal 2019-003673
Application 13/954,265
Technology Center 3700
____________

Before JENNIFER D. BAHR, MICHAEL J. FITZPATRICK, and
ANNETTE R. REIMERS, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL

Appellant, Northwestern University,1 appeals under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 8–11, 16, 17,
and 22–25. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellant is the “applicant” under 37 C.F.R. § 1.42(b) and identifies itself
and Innoblative Designs, Inc. (as an exclusive licensee) as real parties in
interest. Appeal Br. 1.
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Application 13/954,265
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STATEMENT OF THE CASE
The Specification
The Specification’s disclosure relates to radiofrequency ablation
(“RFA”), “a medical procedure used to ablate living tissues [and also] used
to control bleeding in internal organs.” Spec. ¶2.
The Claims
Claims 8–11, 16, 17, and 22–25 are rejected. Final Act. 1. No other
claims are pending. Id. Claims 8 and 22 are the only independent claims.
Appeal Br. 16–18. They are illustrative and reproduced below.
8. A probe for ablating tissue of a body cavity,
comprising:
a shaft;
an inflatable balloon connected to a distal end of said
shaft, said balloon having an external surface and an internal
cavity and being configured to expand within the body cavity,
said balloon having a plurality of spaced-apart apertures
therethrough which are distributed over the surface;
a plurality of tubes housed within said internal cavity of
said balloon, an end of each said tube being sealed with a
respective aperture in said balloon, each said tube defining a
passageway with an open distal end disposed at the balloon
surface; and
an electrode mounted within each said tube, said
electrodes being translatable along the passageway of the
respective tube such that a distal end of each said electrodes can
be extended outwardly from said external surface of said
balloon to penetrate the tissues of the body cavity and can be
retracted inwardly of said external surface of said balloon, said
electrodes adapted to transmit electrical energy over the body
cavity surface in order to ablate the tissue up to a predetermined
depth.
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22. A method of using a probe for ablating tissue of a
body cavity, comprising:
performing a surgical tissue removal to create the body
cavity;
inserting a probe into the body cavity;
engaging a spherical surface on the probe against tissue
of an inner wall of the body cavity;
advancing a plurality of electrodes distributed over the
spherical surface to penetrate the tissue of the inner wall of the
body cavity; and
transmitting electrical energy through said plurality of
electrodes to the tissue of the body cavity in order to ablate the
tissue over substantially the entire body cavity surface up to a
predetermined depth.
Appeal Br. 16–17.
The Examiner’s Rejections
The following rejections, all pursuant to 35 U.S.C. § 103, are before
us:
1. claims 8–11 and 16 over Edwards2 and West3 (Final Act. 2);
2. claim 17 over Edwards, West, and Utley4 (id. at 5); and
3. claims 22–25 over DiCarlo5 and Edwards (id. at 6).

2 US 6,056,744, issued May 2, 2000 (“Edwards”).
3 US 2005/0154386 A1, published July 14, 2005 (“West”).
4 US 2011/0257646 A1, published Oct. 20, 2011 (“Utley”).
5 US 7,959,631 B2, issued June 14, 2011 (“DiCarlo”).
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DISCUSSION
Rejection 1
Appellant argues all claims together. Appeal Br. 5–11. More
specifically, Appellant argues against the rejections of claims 8–11 and 16
on the basis that the Examiner’s rejection of claim 8 is in error.
The Examiner found that Edwards, which discloses a “sphincter
treatment apparatus” (see Edwards, [54]), teaches the subject matter of claim
8 save “an end of each said tube being sealed with a respective aperture in
said balloon,” for which the Examiner turned to West. Final Act. 3–4. In
rejecting claim 8, the Examiner relies on the Edwards embodiment
illustrated in Figure 5B, as modified “such that the apertures of the balloon
device have tubes sealed to each aperture, as West seals apertures.” Final
Act. 3–4 (quotation at page 4).
Figure 5B of Edwards is reproduced below.

Figure 5B shows “a perspective view illustrating a balloon coupled to the
basket assembly.” Edwards 4:32–33.
In [the] embodiment shown in FIG. 5B, an expandable
member 55, which can be a balloon, is coupled to an interior or
exterior of basket assembly 50. Balloon 55 is also coupled to and
inflated by lumen 36 using gas or liquid. In various other
embodiments (not shown), arms 44 may be asymmetrically
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Application 13/954,265
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spaced and/or distributed on an arc less than 360°. Also, arms
44 may be preshaped at time of manufacture or shaped by the
physician.
Id. at 7:29–36 (cited at Final Act. 3). Critical to this Appeal are the
Examiner’s findings that
Edwards . . . teaches a plurality of tubes housed within said
internal cavity of said balloon (tubes 44 within balloon as in col.
7, lines 29–30); an end of each said tube with a respective
aperture in said balloon (apertures 64 at circumferential ends of
tubes 44 facing the outer surface), each said tube defining a
passageway with an open distal end disposed at the balloon
surface (apertures 64 form a distal open end at the balloon
surface given that the apertures are holes forming open spaces on
the balloon, and the apertures 64 form open ends at the distal end
effector); and an electrode mounted within each said tube
(electrode mounted within tubes 44), said electrode being
translatable along the passageway of the respective tube
(electrodes translate along the passageway 64 of the tubes.
Final Act. 3–4.
Appellant points out that, in Edwards, each electrode intersects a
corresponding arm at its approximate midpoint. Id. Thus, according to
Appellant, arms 44 do not define passageways, and none of the electrodes is
“translatable along the passageway of the respective tube,” as recited in
claim 8. Id. at 7 (“Nor does Edwards teach that the arms have passageways
that allow the electrodes to translate as required by claim 8 herein.”).
The Examiner does not dispute Appellant’s factual characterization of
Edwards, but the Examiner insists that Edwards nonetheless meets the claim
language. See Ans. 3 (“Translatable along a passageway of a tube does not
require that the electrodes are translatable within the tube, but rather the
electrodes may be moved along with the tube along the path of the tube.”).
The Examiner points out that claim 8 also recites that “the electrodes are
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‘mounted within each said tube,’ [which] teaches away from sliding within
the tube, and shows that the electrodes may be fixed or set in the tube.” Id.
Appellant has the better position. Claim 8 recites “each said tube
defining a passageway.” Appeal Br. 16. It is this passageway—i.e., a
passageway defined by the tube—that an electrode must be “translatable
along,” per claim 8. Id.
Additionally, the Examiner’s interpretation of “translatable along”
cannot be supported by the Examiner’s interpretation of “mounted” as
“fixed” or “set,” as the latter interpretation itself is unreasonable in light of
the Specification. In that regard, the Specification discloses:
When the electrodes 540 are advanced along the tubes 532, the
distal ends 540 extend generally radially outwardly from the
external surface 506 of the balloon 508 after inflation, and the
distal ends 540 penetrate into the surrounding internal tissue of a
cavity 20 ensure contact between the electrodes 540 and tissue
and potentially to provide additional depth of ablation.
Spec. ¶46. The Specification even states that “the balloon 508 can be
deflated and the electrodes structure 550 will maintain penetration of the
tissues.” Thus, the Specification describes electrodes being movable relative
to the tubes. That the electrodes are movable relative to their respective
tubes is further supported by claim 8 itself, which recites that the electrodes
are translatable along the passageways of the tubes “such that a distal end of
each said electrodes can be extended outwardly from said external surface of
said balloon to penetrate the tissues of the body cavity and can be retracted
inwardly of said external surface of said balloon.” (Emphasis added).
Although Edwards has a passageway extending roughly orthogonally
through each arm 44 at aperture 64, that passageway is not defined by the
arm, as required by claim 8. See Edwards Fig. 5B. In other words, arms 44
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may have transverse-oriented passageways terminating at apertures 64 and
through which electrodes 90 extend, but arms 44 do not define those
passageways, as required in claim 8. Nor are the electrodes translatable
along passageways within the meaning of claim 8.
For the foregoing reasons, we reverse the rejection of independent
claim 8. We likewise reverse the rejection of claims 9–11 and 16, which
depend from claim 8. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988)
(“Dependent claims are nonobvious under section 103 if the independent
claims from which they depend are nonobvious.”).
Rejection 2
Claim 17 depends from claim 8. Appeal Br. 17. The Examiner
rejected claim 17 over the same art as applied against claim 8 plus Utley.
Final Act. 5. However, the Examiner does not rely on Utley in a manner
that could cure the deficiency in the rejection of claim 8. See id. at 6
(relying on Utley solely for its choice of balloon material). Accordingly, we
likewise reverse the rejection of claim 17.
Rejection 3
Appellant argues all claims together. Appeal Br. 12–15. More
specifically, Appellant argues against the rejections of claims 22–25 on the
basis that the Examiner’s rejection of claim 22 is in error.
Independent claim 22 is directed to a method comprising, among
other steps, “performing a surgical tissue removal to create the body cavity.”
Appeal Br. 17. The Examiner reads this limitation onto DiCarlo’s
“percutaneous delivery of [its tissue ablation] device to the target site T.”
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Final Act. 6 (citing DiCarlo ¶29). The Examiner explains that inserting the
device “creates a cavity in T as in at least Fig. 3a-d).” Id.
Appellant argues that “[n]owhere does DiCarlo ‘631 ever teach or
suggest ‘performing a surgical tissue removal to create the body cavity’.”
Appeal Br. 13 (quoting claim 22). The Examiner responds that “tissue
removal does not require excising tissue or otherwise taking tissue out of the
body to create a body cavity.” Ans. 4. The Examiner explains:
Rather, as in Dicarlo, a percutaneous insertion of the probe
results in tissue breaking apart and separating from each other, in
order to remove tissue from a volume to be occupied by the
probe. It is Examiner’s position that this insertion of the probe
of Dicarlo would be a pushing tissue away from where the probe
now resides, such that tissue removal from the cavity defined by
the device occurs.
Id. In other words, according to the Examiner, compressing tissue into an
adjacent location within the body constitutes removal of that tissue from its
original location.
Appellant has the better position. First, the broadest reasonable
construction in light of the Specification for “performing a surgical tissue
removal” means surgically removing tissue from the patient’s body. Indeed,
the Specification repeatedly describes removing cancerous tissue. See Spec.
¶6 (noting that prior art “probes are not configured for use in the
lumpectomy cavity”), ¶7 (“[T]here is a need for a device that can be used to
deliver non-ionizing radiation, such as RFA, to deliver precise levels of
specifically targeted energy to the tissue immediately surrounding the site of
a surgically-removed tumor.”), ¶32 (referring to “the removed tumor”).
Second, after reciting “performing a surgical tissue removal to create
the body cavity,” claim 22 next recites “inserting a probe into the body
cavity.” This suggests that the cavity exists prior to inserting the probe.
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Third, the Examiner’s construction of claim 22 whereby the “tissue
removal” step is necessarily achieved whenever the “inserting a probe” step
is performed, would render the “tissue removal” step meaningless, which is
a disfavored result. See Warner-Jenkinson Co. v. Hilton Davis Chemical
Co., 520 U.S. 17, 29 (1997) (“Each element contained in a patent claim is
deemed material to defining the scope of the patented invention.”); Bicon,
Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are
interpreted with an eye toward giving effect to all terms in the claim.”);
Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 296 F.3d 1106, 1115
(Fed. Cir. 2002) (proposed construction that rendered a portion of the claim
language meaningless held improper).
Claim 22’s recitation of “performing a surgical tissue removal to
create the body cavity” requires tissue removal from a patient’s body.
Merely pushing or compressing tissue within the body does not satisfy this
claim language. Accordingly, we reverse the rejection of independent claim
22. We likewise reverse the rejection of claims 23–25, which depend from
claim 22. See In re Fine, 837 F.2d at 1076.

SUMMARY
Claims
Rejected
35 U.S.C.
§
References/Basis Affirmed Reversed
8–11, 16 103 Edwards, West 8–11, 16
17 103 Edwards, West,
Utley
17
22–25 103 DiCarlo, Edwards 22–25
Overall
Outcome
8–11, 16,
17, 22–25

REVERSED