Ex Parte Sutermeister et al

Patent Trial and Appeal Board

Oct 12, 2018

14076769 (P.T.A.B. Oct. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/076,769 11/11/2013
121974 7590 10/16/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Derek Sutermeister
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
8150BSC0193 2724
EXAMINER
HUPCZEY, JR, RONALD JAMES
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/16/2018 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 DEREK SUTERMEISTER,
CASS HANSON, and DAN QUILLIN 1
Appeal 2017-009119
Application 14/076,769
Technology Center 3700
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a catheter assembly. The
Examiner rejected the claims as anticipated under 35 U.S.C. § 102 and as
obvious under 35 U.S.C. § 103. Pursuant to 35 U.S.C. § 134(a), Appellants
appeal the Examiner's decision to reject the claims as unpatentable. We
have jurisdiction under 35 U.S.C. § 6(b ). The rejections are reversed.
STATEMENT OF THE CASE
The Examiner finally rejected the claims as follows:
1 The Appeal Brief ("Appeal Br.") 1 identifies Boston Scientific Scimed,
Inc. as the real party in interest.
Appeal2017-009119
Application 14/076,769
1. Claims 4---6, 15-18, 20, 22 and 23 under pre-AIA 35 U.S.C. §
102(b) as anticipated by Eberl et al. (US Pat. No. 7,736,362 B2, issued June
15, 2010) ("Eberl"). Ans. 2.
2. Claim 7 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of
Eberl. Ans. 2.
3. Claims 8 and 9 under pre-AIA 35 U.S.C. § 103(a) as obvious in
view of Eberl as applied to claim 7, and further in view of Bek et al. (US
Pat. No. 7,422,587 B2, issued Sept. 9, 2008). Ans. 2.
4. Claim 21 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
in view of Eberl and Swanson et al. (US Pat. No. 5,797,903, issued Aug. 25,
1998). Ans. 2.
Independent claim 4, which is representative of the claimed subject
matter, is reproduced below:
4. A catheter assembly for ablation of a target tissue
compnsmg:
an elongated catheter body having a proximal end portion
and a distal end portion, the elongated catheter body including:
a plurality of individual shafts placed concentric or adjacent one
another, the plurality of individual shafts each defining an
interior wall and an exterior wall, wherein the interior wall of
each of the plurality of individual shafts define a respective
lumen;
a balloon positioned at the distal end portion of the
elongated catheter body and configured to be inflated between an
expanded state and an unexpanded state with the use of a fluid
flow along the lumen defined by at least one of the plurality of
individual shafts; and
an ablation element mounted on the exterior wall of at
least one of the plurality of individual shafts such that the
ablation element is conductively coupled with the balloon;
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Appeal2017-009119
Application 14/076,769
wherein the plurality of individual shafts includes a first
shaft, a second shaft, and a third shaft, each defining a length and
cross-section area for controlled flow of the fluid;
wherein the first, second, and third shaft being placed
concentrically with respect to one another from a central axis, the
first shaft being the innermost, the second shaft being the middle,
and the third shaft being the outermost shaft; and
wherein an outside surface of the innermost shaft and an
inside surface of the middle shaft define an inflow lumen for
allowing fluid flow from the proximal end portion toward
theballoon of the catheter assembly.
ANTICIPATION REJECTION
Claim 4
Claim 4 is directed to a catheter assembly for ablation of target tissue.
The catheter comprises: (1) an elongated body; (2) a balloon at the distal
end of the body; and (3) an ablation element.
The ( 1) elongated body has ( 1 a) a plurality of individual shafts
including first, second, and third shafts ( 1 b) placed concentrically with
respect to a central axis, where the first shaft is innermost, the second shaft
is in the middle, and the third is outermost. Each shaft has (1 c) a lumen and
"cross-section area for controlled flow of the fluid." The claim further
recites that (Id) "an outside surface of the innermost shaft and an inside
surface of the middle shaft define an inflow lumen for allowing fluid flow
from the proximal end portion toward the balloon of the catheter assembly."
The (2) balloon is (2a) is "configured to be inflated between an
expanded state and an unexpanded state with the use of a fluid flow along
the lumen defined by at least one of the plurality of individual shafts."
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Appeal2017-009119
Application 14/076,769
The Examiner found that Eberl describes a catheter assembly with all
the claimed elements. Final Act. 2--4. The Examiner found that Eberl's
catheter comprises (la) first, second and third concentric shafts. Id. at 3.
The Examiner identified Figures 4 and 5 of Eberl as showing this
configuration. Cross sections A-A and B-B of Figure 4 are reproduced
below (shading added to highlight cited elements):
456d 480
456a 456b 456a
480
SECTION A-A SECT!Ofi..8-8
Figure 4 reproduced above shows a cross-section of the catheter
assembly of Eberl. Eberl teaches that 450 is an inner shaft (Eberl, col. 8, 1.
4 7), 480 is an outer shaft surrounding the inner shaft 450 to strengthen the
tube assembly (id. at col. 9, 11. 12-15), and 490 is "an outer sheathing ...
secured to an outer surface of the outer shaft 480 for enhancing a stiffness of
the guide tube assembly 442" (id. at col. 9, 11. 15-17). 456a, 456b, 456c, and
456d are lumens inside the inner shaft 450 that can be used to deliver fluid
or guidewires (id. at col. 8, 11. 4 7----67).
The Examiner identified 450, 480, and 490 ( shown in the figure
reproduced above) as the claimed concentric shafts having lumens allowing
for fluid flow (see elements la, 1 b, le above). Final Act. 3--4. The
Examiner stated that 450 and 480 define a lumen that "allows fluid via the
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Appeal2017-009119
Application 14/076,769
lumen formed at 456 to flow from the proximal end toward the balloon." Id.
The Examiner also stated that "each of 490, 480, and 450 define a respective
interior wall, each would then also define a passageway therethrough taken
as a 'lumen' as presently set forth in claim 4." Ans. 3. The Examiner found
that lumen 456 meets the claimed requirement "a lumen 'allowing for fluid
flow from the proximal end portion toward the balloon of the catheter
assembly."' (See element Id above). Id. at 5.
The Examiner's argument is not persuasive. A "lumen" is a cavity or
a bore of a tube. 2 Claim 4 requires that "an outside surface of the innermost
shaft and an inside surface of the middle shaft define an inflow lumen for
allowing fluid flow from the proximal end portion toward the balloon of the
catheter assembly." See (Id) above. Eberl does not describe an open lumen
between 450 (the inner shaft) and 480 (the middle shaft). As explained
above, 480 is "an outer shaft ... coaxially surrounding the inner shaft 450 to
strengthen and/or to improve a durability of the guide tube assembly."
Eberl, col. 9, 11. 12-15. The Examiner did not identify an evidentiary basis
for finding a lumen between 450 and 480. Likewise, the Examiner did not
identify an evidentiary basis for finding a lumen between 480 and 490 which
is required by the claim ("wherein the interior wall of each of the plurality of
individual shafts define a respective lumen"). To the contrary, 490 is "an
outer sheathing . . . secured to an outer surface of the outer shaft 480 for
enhancing a stiffness of the guide tube assembly." Id. at col. 9, 11. 15-17.
The Examiner did not explain how a sheath secured to a surface would
provide a cavity or bore of a tube.
2 https://www.merriam-webster.com/dictionary/lumen (accessed Oct. 12,
2018).
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Appeal2017-009119
Application 14/076,769
The Examiner also cited 456 of Eberl as a lumen between 450 and
480. Final Act. 3--4; Ans. 5. The Examiner stated "the specific placement
of the inflow lumen to be defined between the concentrically arranged inside
surface of the middle shaft and the outside surface of the innermost shaft is
not required by the broadest reasonable interpretation of the claim in light of
the Specification." Ans. 5.
Each of lumens 456a--456d are located inside lumen 450. See Figure
4 of Eberl reproduced above. If one of these lumens 456 is considered to be
the innermost shaft and concentric with 450 and 480, the Examiner did not
explain how the "outside surface" of the innermost shaft 456 and the "inside
surface" of 450 "define an inflow lumen for allowing fluid flow from the
proximal end portion toward the balloon," as required by the claim. See (Id)
above. The Examiner did not identify disclosure in Eberl that the space in
which the lumens 456a--456d are placed is open and unobstructed such that
fluid flow could occur to the end portion of the balloon. In any event, even
if it were a lumen, as explained above, there is no lumen between 480 and
490 as required by rejected claim 4.
To anticipate under 35 U.S.C. § 102, a publication must "disclose all
elements of the claim within the four comers of the document" and
"arranged as in the claim." Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d
1359, 1369 (Fed. Cir. 2008). Because the Examiner did not establish that
Eberl describes each element of the claimed catheter is arranged as in the
claim, we are compelled to reverse the anticipation rejection of claim 4, and
dependent claims 5 and 6.
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Appeal2017-009119
Application 14/076,769
Claim 15
Independent claim 15 is similar to claim 1, but does not recite that the
shafts are concentric. Rather, the claim states that the first shaft, second
shaft, and third shaft are "positioned adjacent one another." The Examiner
states "Eberl discloses that the first shaft, second shaft, and third shaft being
positioned adjacent one another (450, 480, and 490 are adjacent one
another)." Final Act. 5. Appellants state that innermost shaft 450 is
separated from outermost shaft 490 by shaft 480 and therefore cannot be
said to be "adjacent" to outermost shaft 490. Appeal Br. 11. Appellants also
rely on the same argument as they did for claim 1, that the interior walls of
the shafts 450, 480, and 490 do not define lumens. Id.
The Specification does not define the term "adjacent", but the
embodiments in it show the first, second, and third shafts located near each
other, or touching, with no intervening shaft between them. Spec. ,r 50; Fig.
3. Consistently, the term "adjacent" means "nearby" or having a "common
border."3 It is not reasonable to interpret "adjacent" to mean that two of the
"adjacent" shafts can be separated from each other by a third shaft because
such interpretation would essentially ignore the "adjacent" limitation of the
claim and give it no weight. All limitations in a claim must be given weight.
Thus, we agree with Appellants that Eberl does not described "the first shaft,
second shaft, and third shaft being positioned adjacent one another," as
required by claim 15.
In addition to this, claim 15 requires that "the interior wall of each of
the plurality of individual shafts define a respective lumen." While the
3 https://www.merriam-webster.com/dictionary/adjacent (accessed Oct. 12,
2018).
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Appeal2017-009119
Application 14/076,769
Examiner found that 490 serves as outermost shaft with a lumen, Eberl
describes 490 as "an outer sheathing ... secured to an outer surface of the
outer shaft 480 for enhancing a stiffness of the guide tube assembly." Eberl,
col. 9, 11. 15-17. A lumen is cavity or a bore (such as a hollow catheter) (see
fn. 2). However, 490 is secured to 480. Eberl, col. 9, 11. 15-17. The
Examiner did not provide any evidentiary support for the finding that a
sheathing "secured" to another surface has a cavity between the sheathing
and the surface. The Examiner "maintains," but with no evidence, that
"element 490 defines a hollow space (bore) therethrough for the passage of
the various other structures as shown in at least figure 4." Ans. 3.
Because the Examiner did not establish that Eberl describes each
element of Eberl' s catheter is arranged as in the claim, we are compelled to
reverse the anticipation rejection of claim 15, and dependent claims 5 and 6.
OBVIOUSNESS REJECTIONS
Claims 7-9 and 21 are further rejected as obvious. Final 7-9. The
Examiner did not establish that the elements found to be absent from Eberl
would have been obvious to one of ordinary skill in the art based on Eberl
and the additionally cited publications. Consequently, the rejections of
claims 7-9 and 21 are reversed.
REVERSED
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