Saurav Paul et al.

Patent Trials and Appeals Board

Sep 18, 2019

13340127 - (D) (P.T.A.B. Sep. 18, 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.
13/340,127 12/29/2011 Saurav Paul 0B-1434USO/065513-000394 8243
67337 7590 09/18/2019
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
GHAND, JENNIFER LEIGH-STEWAR
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
09/18/2019 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):
ASJM_Patents@abbott.com
MN-IPMail@dykema.com
Patents@dykema.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte SAURAV PAUL and RIKI CHOU THAO
____________________

Appeal 2019-000803
Application 13/340,127
Technology Center 3700
____________________

Before DANIEL S. SONG, JEREMY M. PLENZLER, and
LEE L. STEPINA, Administrative Patent Judges.

SONG, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
The Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
Final Office Action (“Final Act.”) rejecting claims 1, 2, 5–17, and 24–36 in
the present application. We have jurisdiction under 35 U.S.C. §§ 6(b) and
134(a).
We AFFIRM.

1 The Appellant is St. Jude Medical, Atrial Fibrillation Division, Inc., which
is identified as the real party in interest. Appeal Brief (“App. Br.”) 4.
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The claimed invention is directed to an ablation device. Abstract.
Representative independent claim 35 reads as follows:
35. An ablation device for creating linear lesions, the device
comprising:
a flexible support structure defining a pre-formed closed
loop capable of being retained in the absence of a deforming
force; and
an electrode disposed at a distal end of the closed loop of
the flexible support structure;
wherein the electrode is configured to form a linear lesion,
at least a portion of which is transverse to a longitudinal axis of
the ablation device.
App. Br. 26, Claims App’x (emphasis added).

REJECTIONS
1. The Examiner rejects claims 33 and 34 under 35 U.S.C. § 112,
second paragraph as being indefinite. Final Act. 2.
2. The Examiner rejects claims 35 and 36 under 35 U.S.C.
§ 102(b) as anticipated by Pomeranz (US 5,800,482, iss. Sept. 1, 1998).
Final Act. 3.
3. The Examiner rejects claims 1, 2, 5–17, 24–31, and 33–36
under 35 U.S.C. § 103(a) as unpatentable over Thao (US 2008/0161789 A1,
pub. July 3, 2008) in view of Swanson (US 2003/0088244 A1, pub. May 8,
2003), Vanney (US 2005/0004440 A1, pub. Jan. 6, 2005), and Fleischman
(US 5,836,947, iss. Nov. 17, 1998). Final Act. 4.
4. The Examiner rejects claims 32 and 35 under 35 U.S.C.
§ 103(a) as unpatentable over Thao in view of Swanson and Vanney. Final
Act. 9.
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ANALYSIS
Only those arguments actually made by the Appellant have been
considered in this decision. Arguments that the Appellant could have made
but chose not to make have not been considered and are deemed to be
waived. See 37 C.F.R. § 41.37(c)(1)(iv); In re Jung, 637 F.3d 1356, 1365–
66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072, 1075–76 (BPAI 2010
(precedential)).

Rejection 1
The Examiner rejects claims 33 and 34 under 35 U.S.C. § 112, second
paragraph, as being indefinite because the term “substantially transverse” is
a relative term, which is “not defined by the claim, the specification does not
provide a standard for ascertaining the requisite degree, and one of ordinary
skill in the art would not be reasonably apprised of the scope of the
invention.” Final Act. 2. The Examiner explains that “it is unclear to what
degree the linear lesion must be in order to be ‘substantially transverse’ to
the longitudinal axis.” Final Act. 2.
The Appellant argues that the claims are not indefinite because
“although the specification does not specifically define the term
‘substantially transverse,’ the drawings clearly do.” App. Br. 12, citing
Spec. Figs. 3B, 3C; MPEP § 2173.01. The Appellant also cites dictionary
definitions of “transverse” and “substantially” to argue that “a linear lesion
which is ‘substantially transverse’ to a longitudinal axis of the active
deployment member is a linear lesion that is set crosswise from or made at
right angles to the longitudinal axis of the active deployment member,”
which is depicted in Figures 3B and 3C. App. Br. 13. Thus, the Appellant
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argues that a person of ordinary skill in the art would understand what
“substantially transverse” means based on the plain and ordinary meaning
and in view of the drawings. App. Br. 13.
We agree with the Appellant. Claims are in compliance with 35
U.S.C. § 112, second paragraph, if “the claims, read in light of the
specification, reasonably apprise those skilled in the art both of the
utilization and scope of the invention, and if the language is as precise as the
subject matter permits.” Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802
F.2d 1367, 1385 (Fed. Cir. 1986). The use of “substantially” does not per se
render a claim indefinite. See Verve, LLC V. Crane Cams, Inc., 311 F.3d
1116, 1120 (“It is well established that when the term ‘substantially’ serves
reasonably to describe the subject matter so that its scope would be
understood by persons in the field of the invention, and to distinguish the
claimed subject matter from the prior art, it is not indefinite.”). When a
claim uses a word of degree, like “substantially,” we examine the
Specification to determine whether some standard for measuring that degree
is provided and whether one of ordinary skill in the art would understand
what is claimed when the claim is read in light of the Specification. See
Seattle Box Co. v. Industrial Crating & Packing, Inc., 731 F.2d 818, 826
(Fed. Cir. 1984).
In the present rejection, the Examiner has not explained why the
skilled artisan in view of the Specification would not understand the meets
and bounds of substantially, and we thus reverse the rejection. Although the
Specification lacks a textual standard for determining the degree to which at
least a portion of the linear lesion must be transverse, the Specification is not
entirely silent as to how the pertinent limitation should be interpreted
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through the inclusion of Figures 3B and 3C. We agree with the Appellant
that a person of ordinary skill would understand the claim language
“substantially transverse” in view of Figures 3B and 3C, and the plain and
ordinary meaning of the terms “substantially” and “transverse,” to thereby
understand that what is being claimed “is a linear lesion that is set crosswise
from or made at right angles to the longitudinal axis of the active
deployment member.” App. Br. 13.
Therefore, in view of the above considerations, we reverse this
indefiniteness rejection.

Rejection 2
The Examiner rejects claims 35 and 36 as anticipated, finding that
Pomeranz discloses an ablation device as claimed in which “the electrode is
configured to form a linear lesion (e.g. ablates tissues to form linear lesion),
at least a portion of which is transverse to a longitudinal axis of the ablation
device (e.g. ablation section conforms to the cardiac tissue Fig. 6C).” Final
Act. 3, citing Pomeranz Fig. 6C.
The Appellant disagrees and argues that
Even if one were to assume, arguendo, that a highly magnified
version of Fig. 6C of Pomeranz may show a minute portion of
the ablation section 16 that could be considered “transverse” to
the longitudinal axis of the ablation device, Fig. 6C of
Pomeranz does not disclose an electrode configured to form a
linear lesion that is “transverse” to the longitudinal axis of the
ablation device according to the plain and ordinary meaning of
the word “transverse.”
App. Br. 14–15.
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We are not persuaded that the Examiner erred. The Appellant focuses
on Figure 6C, but overlooks the recited language of claim 35, and the fact
that Figure 6C was cited by the Examiner as an example of conforming the
ablation section to tissue, as well as the disclosure of Pomeranz, which
describes the manner in which Pomeranz’s linear lesion catheter operates.
In particular, we first note that independent claim 35 does not recite
that the ablation device is configured to only create linear lesions, which are
transverse to the longitudinal axis of the device. Indeed, while the claim
recites that the electrode is “configured to” form a linear lesion, a portion of
which must be transverse, the claim does not recite, nor does the
Specification describe, any specific structure or characteristic attributable to
the electrode or the ablation device for attaining the recited lesion.
Moreover, as noted, claim 35 recites that only a portion of the linear lesion
need be transverse. Second, the claim recites that it is the resultant lesion,
which at least a portion must be transverse to the longitudinal axis of the
ablation device. The recited lesion is not part of the recited ablation device,
and thus, the claim merely functionally recites the orientation of the recited
portion of the lesion. Accordingly, the claim limitation at issue is satisfied if
the linear lesion catheter of Pomeranz is designed to provide a linear lesion
that is, at least in portion, transverse to the longitudinal axis of the ablation
device in at least some instances.
Turning to Pomeranz, the position of its ablation section 16 is
described as being adjustable via movement of the end of baffle wire 26 and
tubing 34. See Pomeranz, col. 7, ll. 9–36; Figs. 6A–6D. Specifically,
Pomeranz teaches that
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The height, location and size of the loop 22 may be adjusted to
position the ablation section 16 of the apparatus against the
desired surface within the heart chamber and to maintain contact
between the ablation surface of the catheter and the target surface
within the heart chamber. These adjustments can be made by
moving end 26 and/or tubing 34 distally or proximally as needed,
and also by rotating the main shaft 12.
For example, tubing 34 may be moved distally to advance
ablation section 16 and to thereby increase its curvature as shown
in FIG. 6C, if such curvature will conform the ablation section
16 to the cardiac tissue T.
Pomeranz, col. 7, ll. 24–36.
Thus, the linear lesion ablation catheter 10 of Pomeranz is designed to
form a linear lesion, at least a portion of which is transverse to the
longitudinal axis of the ablation device by positioning its ablation section 16
at the middle of the loop at the distal end thereof, and advancing the same to
conform to, and ablate, the tissue that is at a plane normal to the longitudinal
axis of the ablation device.
Therefore, we agree with the Examiner that “Pomeranz teaches an
apparatus . . . for linear lesion ablation which discloses an electrode (e.g. 16)
that can be placed at various locations on the cardiac tissue of interest (e.g.
Figs. 6C-6D) therefore the structure of the electrode inherently possess the
functional limitation.” Ans. 11.
Accordingly, we affirm Rejection 2.

Rejections 3 and 4
The Examiner rejects claims 1, 2, 5–17, 24–31, and 33–36 as
unpatentable over Thao in view of Swanson, Vanney, and Fleischman
(Rejection 3). Final Act. 4. As to independent claims 1 and 35, the
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Examiner finds, inter alia, that Thao discloses an ablation device, which
“may be formed in various shapes in order to better fit the contour of the
target tissue including a noose, a spatula or the shape of the ostium of the
pulmonary vein (e.g. paragraphs [0077], [0079]).” Final Act. 4. Based
thereon, the Examiner concludes that it would have been obvious to have
implemented Thao as a “preformed closed loop.” Final Act. 4. The
Examiner also finds that “Thao discloses the device being used inside blood
vessels and heart chambers (e.g. paragraph [0064]),” and that it was known
to use a closed loop with an electrode at a distal end thereof to provide
lesions to tissue within the heart “in order to obtain and retain continuous
uniform contact with the cardiac tissue across the entire length of the
ablation electrode surface in the presence of the constant movement of the
heart.” Final Act. 4–5, citing Swanson, Figs. 3, 4, 6, 10, 12, 16–19; and
Vanney Figs. 2–4. The Examiner specifically points out that Figure 3C of
Vanney and Figures 19A and 19B of Swanson show electrodes on a distal
end of a closed loop that form a linear lesion. Ans. 13–14. The Examiner
further finds that Fleischman discloses a flexible loop that supports
electrodes wherein the loop may be deployed and controllably deformed by
a movable rod. Final Act. 5, citing Fleischman, Figs. 13, 15, 16.
Accordingly, based on the above findings, the Examiner concludes
that it would have been obvious to have
shape[d] the Thao device into the shape of a pre-formed/pre-
shaped closed loop with an electrode disposed at a distal end of
the closed loop that is retained . . . to obtain and retain
continuous uniform contact with the cardiac tissue across the
entire length of the ablation electrode surface in the presence of
the constant movement of the heart . . . [and to have modified]
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the ablation device of Thao with the teachings of Fleischman to
include an active deployment member.
Final Act. 5.
The Examiner relies on substantially the same findings and
conclusions in rejecting independent claim 24. Final Act. 7–8. The
Examiner also rejects independent claims 32 and 35 as unpatentable over
Thao in view of Swanson and Vanney (Rejection 4), based on substantially
the same findings and conclusions set forth relative to Rejection 3. Final
Act. 9–10.
The Appellant argues independent claims 1, 24, 32, and 35 rejected in
Rejections 3 and 4 as a group, noting that each of these claims recites “an
electrode ‘configured to form a linear lesion, at least a portion of which is
transverse to a longitudinal axis of the ablation device.’” App. Br. 16; see
also id. at 18. The Appellant argues that
The fact that Thao’s ablation catheter can be formed into a
noose, a spatula . . . or any other shape in no way suggests that
a linear lesion formed by the electrode of the ablation catheter
is transverse to a longitudinal axis of the ablation device. . . .
There is no reason to believe, for example, that Thao’s noose-
shaped or spatula-shaped ablation catheter would not produce a
linear lesion that is parallel (as opposed to transverse) to the
longitudinal axis of the catheter.
App. Br. 16–17.
The Appellant further argues that
While Swanson and Vanney may teach various electrode
configurations and lengths along loop structures, this in no way
suggests that a linear lesion formed by the electrode of the
ablation catheter is transverse to a longitudinal axis of the
ablation device. At best, Swanson teaches a linear lesion
pattern as shown in FIG. 33A; however, there is no disclosure,
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teaching, or suggestion that this linear lesion is transverse to a
longitudinal axis of the ablation device.
App. Br. 17–18.
The Appellant’s arguments are unpersuasive for reasons similar to
those discussed above relative to Rejection 2 in that they overlook the
recited language of the independent claims, the disclosures of the prior art
applied, and reasoning provided by the Examiner in rejecting the claims.
The claims do not recite that the ablation device must be configured to only
create transverse linear lesions, and instead, recites that it is at least a portion
of the resultant lesion, which must be transverse. Accordingly, the
limitation at issue is satisfied by implementing the ablation catheter of Thao
as a closed loop as suggested therein, and as known in the art, with an
electrode disposed at the distal end thereof, such ablation catheter being
designed to form a transverse linear lesion, at least a portion of which is
transverse to the longitudinal axis, when applied to “obtain and retain
continuous uniform contact with the cardiac tissue” (Final Act. 5) that is at a
plane normal to the longitudinal axis of the ablation device.
Therefore, in view of the above considerations, we affirm the
Examiner’s obviousness rejection relative to independent claims 1, 24, 32,
and 35. The Appellant relies on dependency for patentability of claims 2, 5–
17, 25–31, 33, 34, and 36. App. Br. 18. Accordingly, the rejection of these
dependent claims is also affirmed.

CONCLUSIONS
1. Rejection 1 of claims 33 and 34 as being indefinite is Reversed.
2. Rejection 2 of claims 35 and 36 as anticipated is Affirmed.
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3. Rejections 3 and 4 of claims 1, 2, 5–17, and 24–36 as
unpatentable are Affirmed.

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

AFFIRMED