Ex Parte Anwar et al

Patent Trial and Appeal Board

Jun 21, 2013

11197286 (P.T.A.B. Jun. 21, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte AZAM ANWAR and PAUL J. DURFEE
__________

Appeal 2012-000213
Application 11/197,286
Technology Center 3700
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal1 under 35 U.S.C. § 134 involves claims to an apparatus
for addressing an occlusion in a vascular environment. The Examiner
entered rejections for new matter and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse the new matter rejection and affirm the obviousness
rejection.

1 The Real Party in Interest is Advance CV Concepts, Inc. (App. Br. 4.)
Appeal 2012-000213
Application 11/197,286

2
STATEMENT OF THE CASE
Claims 1, 3, 4, 6-10, 21, and 22 stand rejected and appealed (App. Br.
4). Appellants have not argued any of the claims separately, so the claims
stand or fall together. See 37 C.F.R. § 41.37(c)(1)(vii).
Claim 1 is representative and reads as follows:
1. An apparatus for addressing an occlusion in a vascular
environment, comprising:
a wire;
a tip integrally part of the wire and configured to have a
diameter that does not exceed a diameter of the wire, the tip operable
to burrow into an occlusion in a vascular environment, wherein the tip
and the wire point in a substantially similar direction when the wire is
rotated, wherein the wire tapers at its distal end to form the tip, which
is shaped as a cone having a single point for an initial contact with the
occlusion;
a coil section having rings of a same diameter, whereby the
wire is rotated by a drive unit that triggers burrowing into the
occlusion, the tip having a proximal end where the coil section is
positioned, the tip also having a distal end adapted to create a pathway
in the occlusion prior to the coil section traversing the occlusion,
wherein each of the rings of the coil section adhere to the wire during
rotation of the wire;
a brake configured to limit rotational movement of the wire;
a battery power source, which is configured to supply energy
for the drive unit; and
a housing configured to include the drive unit wherein at least a
portion of the wire to be fed into the occlusion is resident in the
housing.

The following rejections are before us for review:
(1) Claims 1, 3, 4, 6-10, 21, and 22, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 4); and
Appeal 2012-000213
Application 11/197,286

3
(2) Claims 1, 4, 6, 8-10, 21, and 22, under 35 U.S.C. § 103(a) as
obvious over Baylis2 and Shturman3 (Ans. 4-7).
NEW MATTER
In rejecting claims 1, 3, 4, 6-10, 21, and 22, under 35 U.S.C. § 112,
first paragraph, the Examiner found that the Specification failed to “to
describe the rings of the coil section ‘adhere to the wire’ during rotation of
the wire. Therefore, the limitation is considered new matter” (Ans. 4).
Appellants argue that support for the language at issue can be found
throughout the disclosure, and in particular point to Figure 2 (see App. Br. 7-
8).
The Examiner responds that, “[a]lthough Figure 2 illustrates the rings
of the coil section surround the wire, there is no description of the rings
‘adhering to’ the wire during rotation of the wire in the original disclosure”
(Ans. 7).
We find that Appellants have the better position.
As our reviewing court has noted, “[i]n order to satisfy the written
description requirement, the disclosure as originally filed does not have to
provide in haec verba support for the claimed subject matter at issue.”
Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir.
2000).
Thus, it is “not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes

2 Baylis et al., U.S. Patent No. 4,177,797 (issued Dec. 11, 1979).
3 Shturman et al., U.S. Patent No. 5,893,857 (issued Apr. 13, 1999).
Appeal 2012-000213
Application 11/197,286

4
including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA
1976) (citation omitted)
In this instance it may be true, as the Examiner argues, that the
Specification does not expressly state that “each of the rings of the coil
section adhere to the wire during rotation of the wire” as recited in claim 1.
However, the Specification does describe operation of the disclosed device
as follows:
[S]ystem 10 can be engaged (or turned ON) such that a rotation
of tip 12 and of coil section 32 is initiated. As system 10
rotates, it pulls itself into blockage 60. While system 10 pulls
itself into blockage 60, the rotation of coil section 32 operates
to embed plaque (and any other materials present at the site)
into its core and its rings.

(Spec. 15 (emphasis added).)
Given the disclosure in Figure 2 of coil section 32 closely disposed on
both wire 14 and the proximal portion of tip 12, combined with the
Specification’s disclosure that the coil section and tip rotate together when
the device is turned on, we agree with Appellants that a skilled artisan would
have recognized that the rings of the coil section adhere to the wire when the
wire is rotated, as recited in claim 1. We therefore reverse the Examiner’s
new matter rejection.
OBVIOUSNESS
In rejecting claim 1 as obvious, the Examiner found that Baylis
described an apparatus capable of addressing an occlusion in a vascular
environment, the apparatus including a wire with a tip having the claimed
features, as well as the coil section required by claim 1 (see Ans. 5). The
Examiner conceded, however, that Baylis’ device differed from the device
Appeal 2012-000213
Application 11/197,286

5
recited in claim 1 in that “Baylis fails to disclose a brake, a drive unit, a
battery power source, and a housing” (id.).
To address those deficiencies, the Examiner cited Shturman as
describing a similar device, also capable of addressing an occlusion in a
vascular environment, the device including a power source driven wire, a
brake unit, and a housing as required by claim 1 (see id.).
Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious to “construct Baylis’s
device with a brake, a power source, a drive unit, and a housing as taught by
Shturman. Doing so would provide a device that can be easily controlled by
the user, thus reducing the risk of damaging the vessel” (id.). The Examiner
further reasoned that an ordinary artisan would have considered it obvious to
substitute Shturman’s compressed gas power source, and instead use “well
known batteries for a power source” (id. at 6).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

Appellants’ arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner’s prima facie case of obviousness as
to claim 1.
Appellants initially urge that at least nine limitations in claim 1 are not
found in Baylis and Shturman (App. Br. 8-9; see also Reply Br. 3-4). We
are not persuaded.
Appeal 2012-000213
Application 11/197,286

6
The Examiner concluded that the term “wire” in claim 1 encompasses
needle 1 of Baylis’ device (see Ans. 5). In particular, the Examiner stated
that the “term ‘wire’ is interpreted as ‘a strand or slender rod’ and it is the
Examiner’s position that Baylis’s [needle] member 1 meets this
interpretation” (id. at 8).
Appellants urge that “the Baylis reference has no wire” (App. Br. 11,
see also Reply Br. 7). Appellants have not, however, clearly or specifically
explained why the Examiner’s definition of “wire” is unreasonable or
contrary to the definition a skilled artisan would accept, nor have Appellants
advanced clear or specific evidence to show that it was unreasonable for the
Examiner to interpret claim 1’s wire as encompassing the needle element 1
of Baylis’ device.
Turning to the tip of Appellants’ claim 1, we acknowledge that tip 6
of Baylis’ device might not be particularly evident from Figure 1 of Baylis,
as Appellants seem to argue (see App. Br. 10; see also Reply Br. 5).
However, as the Examiner points out, and as required by claim 1, Figure 2 of
Baylis distinctly shows tip 6 as being integral with the remainder of element
1 of Baylis’ device, and the supporting disclosure in Baylis supports not
only the integral nature of the relationship between element 1 and tip 6, but
also the conical single-pointed shape required by claim 1 (see Baylis, col. 3,
ll. 41-44 (“The distal end 6 of the needle 1 comprises a sharp conical needle
point which permits the inital [sic] penetration of the needle 1 into the
patient’s body to be relatively painless with minimal trauma.”)).
We note, as Appellants argue, that Baylis’ device is for obtaining
tissue biopsies rather than burrowing into occlusions in a vascular
environment (see App. Br. 11 (citing Baylis, col. 4, ll. 50-58); see also Reply
Appeal 2012-000213
Application 11/197,286

7
Br. 7-8 (citing Baylis, col. 3, ll. 50-55)). Appellants have not, however,
pointed to any clear or specific evidence undercutting the Examiner’s
finding that Baylis’ tip would be operable to burrow into an occlusion in a
vascular environment.
To the contrary, given that the sharp needle’s point has the capacity to
penetrate and bore into tissue to ultimately obtain a biopsy, as shown
sequentially in Baylis’ Figures 2-4 and explained in the portions of Baylis
cited by Appellants, we find that a preponderance of the evidence supports
the Examiner’s finding that Baylis’ tip would also be operable to burrow
into an occlusion in a vascular environment, as claim 1 requires.
As to the claimed coil section, we are not persuaded that Appellants
have adequately explained why the helical thread of Baylis’ device, which
effectively forms a set of coiled rings disposed on the external surface of
Baylis’s needle (see, e.g., Baylis Fig. 2) inherently identical in structure to
those in figure 3 of the Specification (see, e.g., Spec. Fig. 3; Ans. 8), and
which rotates with Baylis’ needle (see, e.g., id. at col. 3, ll. 57-60), fails to
meet claim 1’s requirements for the coiled section.
Turning to the other reference, we acknowledge, as Appellants argue
(see App. Br. 13; see also Reply Br. 8-9), that Shturman is directed to an
atherectomy device which removes atherosclerotic tissue from artery walls
(see Shturman, col. 1, ll. 4-9), in contrast to Appellants’ intended use of
claim 1’s device, burrowing into total blood vessel occlusions. We also
acknowledge, as Appellants also argue (see App. Br. 14; see also Reply Br.
10), that Shturman uses its brake to stop the device’s guidewire from
spinning, rather than stopping the outer driven shaft that surrounds the
Appeal 2012-000213
Application 11/197,286

8
guidewire and ultimately ablates undesired tissue from the artery wall (see
Shturman, col. 9, ll. 29-42).
However, as we understand it, the Examiner did not cite Shturman as
evidence that an ordinary artisan would have been prompted to literally
incorporate the specific configuration of components from Shturman into
Baylis. Rather, the Examiner cited Shturman as evidence that a skilled
practitioner would have recognized, in the art of rotationally-driven tissue-
removing devices, that it would be useful in such devices, including the
device described by Baylis, to employ a power source and brake, deployed
in a housing, because “[d]oing so would provide a device that can be easily
handled and controlled by the user” (Ans. 9).
Thus, the fact that Shturman’s device uses its brake to control
guidewire rotation does not persuade us that it was unreasonable for the
Examiner to find that an ordinary artisan would have thought it desirable to
operate Baylis’ device using a power source, and to control it with a brake
mechanism. As the Supreme Court has explained, “the [obviousness]
analysis need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). Accordingly, a “person
of ordinary skill is . . . a person of ordinary creativity, not an automaton.”
Id. at 421.
As to claim 1’s requirement for a battery power source, while
Appellants urge that neither reference discloses that type of power source
(see App. Br. 14; see also Reply Br. 10), Appellants do not dispute the
Examiner’s finding (see Ans. 6, 9) that battery power sources suitable for
Appeal 2012-000213
Application 11/197,286

9
driving devices such those as described by Baylis and Shturman were well
known. Moreover, we note Shturman’s disclosure that its tissue-removing
device can be driven by “a compressed gas drive turbine or similar supply of
rotational motion” (Shturman, col. 6, ll. 56-57 (emphasis added)). Thus,
while Appellants argue to the contrary (see App. Br. 14; see also Reply Br.
10), Shturman supports the Examiner’s finding that an ordinary artisan
would have reasoned that in additional to compressed gas, equivalent power
sources, including well known battery power sources, would have been
useful for driving rotationally actuated tissue removing devices.
As to Appellants’ teaching away argument, the fact that Shturman is
directed to an atherectomy device does not persuade us that an ordinary
artisan would have been led away from a device having the features recited
in claim 1, or would have considered it undesirable to modify Baylis’ device
to include a housing-enclosed battery powered driving unit and a brake
mechanism. See DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567
F.3d 1314, 1327 (Fed. Cir. 2009) (“A reference does not teach away . . . if it
merely expresses a general preference for an alternative invention but does
not ‘criticize, discredit, or otherwise discourage’ investigation into the
invention claimed.”) (citing In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004).
As to Appellants’ argument regarding the advantageousness of the
claimed device as compared to prior art devices, for example with respect to
producing inflammation (see App. Br. 15; see also Reply Br. 12), Appellants
do not direct us to any clear or specific evidence comparing the results of
using the claimed device to the results of using either of the cited prior art
devices.
Appeal 2012-000213
Application 11/197,286

10
We are also not persuaded, as Appellants argue (see App. Br. 16-17)
that the Examiner failed to provide an adequate non-hindsight-based
rationale for modifying Baylis’ device to have the features recited in claim 1.
As noted above, the Examiner’s position, essentially, is that adding a battery
powered drive unit and brake deployed in a housing to Baylis’ device would
make it easier to use and control (see Ans. 6, 9). Appellants have not
pointed to any clear or specific evidence suggesting that this rationale would
only be hindsight based, or would have been an unreasonable inference from
the cited references.
In sum, for the reasons discussed, Appellants’ arguments do not
persuade us that a preponderance of the evidence fails to support the
Examiner’s prima facie case that an ordinary artisan would have considered
claim 1 obvious in view of Baylis and Shturman. We therefore affirm the
Examiner’s rejection of that claim over those references.
As they were not argued separately, claims 4, 6, 8-10, 21, and 22 fall
with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We reverse the Examiner’s rejection of claims 1, 3, 4, 6-10, 21, and
22, under 35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement.
We affirm the Examiner’s obviousness rejection of claims 1, 4, 6, 8-
10, 21, and 22, over Baylis and Shturman.

Appeal 2012-000213
Application 11/197,286

11
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

lp