Ex Parte Engel et al

Board of Patent Appeals and Interferences

Aug 23, 2012

10890960 (B.P.A.I. Aug. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte REBECCA LYNN ENGEL, DONALD R. SANDMORE,
DAVID BRUCE DEWINDT, FREDERICK ALAN SHOREY, JR.,
and DAVID EDWARD WESTON
__________

Appeal 2011-008731
Application 10/890,960
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a cannula.
The Examiner has rejected the claims as indefinite and/or obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
The Specification describes a cannula having “a wall with a
circumference defining a lumen” and “one or more apertures extending
through the wall interconnected with the lumen” (Spec. 5: 4-9). The
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Specification also discloses that the apertures “are formed to have a
noncircular shape,” which “may be oval, elliptical, eye shaped or some other
non-circular [shape] having a longer major axis and a shorter minor axis”
(id. at 5: 9-11).
In addition, the Specification discloses a cannula having “one or more
reinforcing ribs formed surrounding the lumen” (id. at 5: 21-22; see, for
example, Figure 12a). The Specification also discloses that the “ribs may be
interconnected by a link forming an inner wall around the lumen and a fluid
passageway between the ribs” (id. at 5: 25-27; see, for example, Figure 10).
Claims 1, 4-7, 10, 11, 16-18, 20, and 21 are on appeal (App. Br. 5).
We will focus on claims 1, 5, 17, and 20, which read as follows:
1. A cannula, comprising:
a body comprising a lumen, a proximal end, and a distal end
comprising a flexible tip comprising an outer wall and inner wall, wherein
the outer wall comprises a plurality of non-circular apertures in fluid
communication with the lumen;
wherein the lumen comprises a longitudinal axis; and
the outer wall comprises a plurality of ribs that hold the inner wall in
spaced relation to the outer wall to prevent kinking and provide support to
prevent the tip from kinking when the tip is flexed.
5. The cannula of claim 1, wherein each rib comprises a first side
extending into the lumen and a second side extending into the lumen.
17. A cannula, comprising:
a body comprising a proximal end and a distal end comprising a tip
sized and shaped to engage a patient’s heart, wherein the tip comprises an
open end, a lumen formed in the body, the lumen extending from the
proximal end to the open end of the tip, the lumen having a longitudinal
axis, wherein the body comprises a first rib extending into the lumen,
wherein the rib comprises a first side, a second side and a top, the first side
having a sloped relation with the body, the second side having an arcuate
cross section providing a sloped relation with the body.
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20. A kink resistant cannula comprising:
a body comprising a proximal end and a distal end comprising a tip;
an outer wall defining a lumen in the body between the proximal end
and the tip;
a plurality of ribs formed on the tip extending into the lumen, the ribs
having a top spaced from the outer wall; and
a plurality of non-circular shaped apertures punched in the body in
fluid communication with the lumen sized and shaped to resist kinking of
the body when flexed during use.
Claim 5 stands rejected under 35 U.S.C. § 112, second paragraph
(Final Rej. 2; Ans. 2).
Claims 1, 5-7, and 16-18 stand rejected under 35 U.S.C. § 103(a) as
obvious over Balbierz et al. (US 5,599,291, Feb. 4, 1997) (Ans. 3).
Claims 1, 4, 10, 11, 17, 20, and 21 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Zakko (US 4,902,276, Feb. 20, 1990) in view of
Balbierz (Ans. 4).
Claim 1 stands rejected under 35 U.S.C. § 103(a) as obvious over
Balbierz in view of de la Rama et al. (US 6,246,914 B1, Jun. 12, 2001)
(Ans. 6).
Claims 1 and 20 stand rejected under 35 U.S.C. § 103(a) as obvious
over Zakko in view of Balbierz and de la Rama (Ans. 6).
I
In rejecting claim 5 as indefinite, the Examiner finds that “it is not
clear whether the rib described in claim[] 5 . . . is intended to be the plurality
of ribs located at the outer wall (as described in claim 1), or the plurality of
ribs located at the body (as described in claim 4)” (Final Rej. 2). However,
as noted by Appellants, claim 1 does not depend from claim 4 (App. Br. 10).
Thus, we agree with Appellants that it is clear that “each rib” of claim 5
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refers to each of the “plurality of ribs” recited in claim 1. We therefore
reverse the indefiniteness rejection of claim 5.
II
The Examiner finds:
Balbierz discloses a cannula comprising a body, a flexible tip
sized to engage the heart, comprising a plurality of
apertures (134) which, by virtue of being drainage holes for
draining fluid from the lumen, are considered to extend through
the inner wall; the tip having an outer wall, a lumen (32)
extending from the proximal end to the tip (see Fig. 10), and a
plurality of ribs (142) extending into the lumen toward the
longitudinal axis and evenly distributed around an axis of the
tip. Balbierz additionally discloses the ribs having a first and
second side extending into the lumen (see Fig. 10), the second
side having an arcuate cross-section, and a top forming an inner
surface contacting the lumen.
(Ans. 4.) The Examiner also finds “that Balbierz does not appear to disclose
the apertures to be non-circular,” but that “merely making the apertures non-
circular represents an obvious change in shape of the components and is
considered to be within the level of ordinary skill in the art” (id.).
Analysis
Balbierz discloses a ureteral stent 110 having “internal ribs 142 within
the lumen 32 longitudinally along the body portion 118 as illustrated in
FIG. 10 so as to reduce the chance of kinking while the stent 110 is
advanced into the ureter 30” (Balbierz, col. 9, ll. 35-38).
With regard to claim 1, Appellants argue that “the Examiner fails to
describe, and the Balbierz reference fails to show, any structures of the
Balbierz device that constitute an outer wall and an inner wall held in spaced
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relation to each other by a plurality of ribs at a distal end tip of its cannula”
(App. Br. 12 (emphasis omitted)). We agree.
The Examiner relies on Balbierz Figure 10 (Ans. 4 & 8). The
Examiner considers the exterior wall of Balbierz’s device to be the outer
wall and the inner edge of the rib 142 to be the inner wall (id. at 8).
Although we agree with the Examiner “that a wall having inner and outer
surfaces can be thought of as having an inner wall (i.e., inner surface) and an
outer wall (i.e., outer surface)” (id. at 8-9), we agree with Appellants that
Balbeirz fails to disclose inner and outer walls that are held “in spaced
relation” by a plurality of ribs, as required by claim 1 (App. Br. 13; Reply
Br. 5).
With regard to claim 17, the Examiner finds:
[A] “cannula” may be defined broadly reasonably as a “tube for
transporting fluid.” . . . [T]he structure of Balbierz is a tube for
transporting fluid and therefore may be reasonably broadly
considered to be a cannula. The device of Balbierz may also be
capable of engaging (e.g., contacting, touching, interacting
with) a patient’s heart. . . . Fig. 10 of Balbierz fairly shows such
ribs. . . . The first and second sides are located on the side of the
rib (the first and second sides being roughly opposite one
another along the axial length of the rib) with the second side
having an arcuate cross-section by virtue of the entire rib,
including the second side being arcuate.
(Ans. 8.) Appellants have not adequately explained why the Examiner’s
position is in error. We note Appellants’ argument that a cannula “is defined
as ‘a tube . . . used for irrigation of a cavity’” (App. Br. 12). However, even
assuming that this is the broadest reasonable interpretation, Appellants have
not adequately explained why Balbierz’s device could not be used for
irrigation of a cavity.
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Conclusion
The evidence does not support the Examiner’s conclusion that
Balbierz renders claim 1 obvious. We therefore reverse the obviousness
rejection over Balbeirz of claim 1 and of claims 5-7 and 16, which depend
from claim 1.
The evidence does, however, support the Examiner’s conclusion that
Balbierz renders claim 17 obvious. We therefore affirm the obviousness
rejection of claim 17 over Balbierz. Claim 18 is not separately argued and
therefore falls with claim 17. 37 C.F.R. § 41.37(c)(1)(vii).
III
The Examiner relies on Zakko for disclosing
a cannula comprising a body, a flexible tip, the tip having an
outer wall, a lumen (50') extending from the proximal end to
the tip (see Fig. 7), and a plurality of ribs extending into the
lumen toward the longitudinal axis (see Fig. 8); a first wall
segment and a first interconnecting link (bounding element 52')
comprising an interior channel formed between the inner wall,
outer wall and ribs; as shown in Fig. 8, a second
interconnecting link is present (bounding element '54) and a
second passageway (54') formed by the ribs; and a plurality of
apertures (62') in fluid communication with the lumen (see
Fig. 8).
(Ans. 4-5.) The Examiner finds “that Zakko does not disclose the apertures
to be non-circular,” but that “merely making the apertures non-circular
represents an obvious change in shape of the components and is considered
to be within the level of ordinary skill in the art” (id. at 5).
The Examiner relies on Balbierz for disclosing “a cannula comprising
a body, a flexible tip sized to engage the heart, with ribs having a first and
second side extending into the lumen (see Fig. 10), the second side having
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an arcuate cross-section, and a top forming an inner surface contacting the
lumen” (id.). The Examiner concludes that it would have been obvious “to
implement the ribs of Balbierz into the device of Zakko since Balbierz
specifically discloses the ribs being useful to reduce the chance of kinking
while being advanced into the body to ensure that drainage is not inhibited”
(id.).
Analysis
Zakko discloses an apparatus “for therapeutic treatment of
obstructions in bodily organs by high rate solvent circulation, particularly for
gallbladder or common bile duct stones” (Zakko, col. 3, ll. 3-7). In
particular, Zakko discloses a three lumen catheter as depicted in Figures 7
and 8 (id. at col. 8, ll. 50-52).
Appellants argue:
As is discussed above relative to the Balbierz reference, the
Zakko reference similarly fails to disclose a perfusion cannula
with a tip that is sized and shaped to engage a patient’s heart, as
is recited in the present claims, but instead discloses a catheter
having a series of lumens extending through its body. Further,
there is nothing in the Zakko reference that teaches or suggests
that its catheters have a flexible tip, as in the present claims.
(App. Br. 15.) However, as with Balbierz, Appellants have not adequately
explained why Zakko’s device cannot be considered a cannula or, as recited
in claim 17, does not have a tip that is sized and shaped to engage a patient’s
heart. With regard to the tip being flexible, as recited in claim 1, we agree
with the Examiner that the pigtail shape depicted in Zakko’s Figure 7
supports the Examiner’s finding that Zakko’s catheter has a flexible tip
(Ans. 4).
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Appellants also argue:
the Examiner fails to describe, and the Zakko reference fails to
show, any structures of its apparatus that constitute an outer
wall and an inner wall held in spaced relation to each other by a
plurality of ribs at a distal end tip of its cannula, as in the
present claim 1.
(App. Br. 16.) However, the Examiner finds:
Fig. 8 of Zakko is fairly clear in showing such an apparatus.
Zakko discloses an outer wall, i.e. the outer surface of the
apparatus which has at least one rib (indeed, a plurality of ribs
such as those projections on either side of element 62'), the ribs
bounding, for instance, spaces 52' and 54', with the inner wall
being on the opposite side of the spaces from the outer wall.
(Ans. 10.) Appellants have not adequately explained why the Examiner’s
position is in error.
In addition, Appellants argue that “[t]here is nothing in Zakko that
teaches or suggests a reason to change the shape of its apertures to be any
shape other than circular” (App. Br. 17). We are not persuaded.
Zakko discloses that “there are openings 62 in the wall of the catheter
that provide a means for communication of fluid between the gallbladder
and the aspiration lumen [50]” (Zakko, col. 9, ll. 2-5). In is not clear from
Zakko’s Figures 5 and 7 that these openings are circular rather than ovular.
However, even if they are circular, we agree with the Examiner that it would
have been prima facie obvious to include openings that are not circular
(Ans. 5). Appellants argue that the “present application discloses the
desirability of having apertures with various shapes that exhibit buckle
resistant properties” (App. Br. 16). However, Appellants have not provided
evidence indicating that non-circular apertures, as opposed to those that are
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circular, provide this property. Thus, Appellants have not shown that non-
circular apertures provide an unexpectedly superior result.
With regard to claim 17, Appellants argue:
Zakko does not even teach or suggest any rib extending into a
lumen in its device, [thus] it follows that the Zakko reference
does not teach or suggest a rib configuration that includes first
and second sides being sloped relative to a body of a catheter,
and nothing in Balbierz cures these deficiencies.
(App. Br. 17.) We are not persuaded. The Examiner finds that Zakko’s “rib
comprises sloped sides by virtue of the spaces 52' and 54' having sloped
interior walls” (Ans. 10). Appellants have not adequately explained why the
Examiner’s position is in error. Moreover, whether or not Zakko teaches or
suggests the ribs of claim 17, Appellants have not adequately explained why
Balbierz alone, as discussed above, fails suggests the device of claim 17.
Appellants also argue:
[I]ndependent claim 20 is also patentable over the Zakko
reference, either alone or in view of Balbierz, for many of the
same reasons discussed above relative to a cannula having a
distal end with a plurality of ribs and also a plurality of non-
circular shaped apertures. . . . [T]he Examiner also does not
explain or discuss what structures of Zakko would even
arguably constitute ribs on a distal end or tip of its catheter that
have a top surface spaced from an outer wall, as is recited in the
present claim 20.
(App. Br. 17-18.) We are not persuaded by these arguments for the reasons
discussed above.
Conclusion
The evidence supports the Examiner’s conclusion that Zakko together
with Balbierz render claims 1, 17, and 20 obvious. We therefore affirm the
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obviousness rejection of claims 1, 17, and 20 over Zakko and Balbierz.
Claims 4, 10, 11, and 21 are not separately argued and therefore fall with
claims 1, 17, and 20. 37 C.F.R. § 41.37(c)(1)(vii).
IV
The Examiner additionally relies on de la Rama for disclosing “a
catheter having non-circular apertures (12) suitable to allow the catheter to
bend without kinking” (Ans. 6 & 7). The Examiner does not rely on de la
Rama for disclosing an outer wall comprising a plurality of ribs that hold an
inner wall in spaced relation to the outer wall, as recited in claim 1. Thus,
we reverse the obviousness rejection of claim 1 over Balbeirz in view of de
la Rama for the reasons discussed above with regard to the rejection of
claim 1 over Balbeirz alone.
With regard to the rejection of claims 1 and 20 over Zakko, Balbeirz,
and de la Rama, we concluded above that the evidence supports the
Examiner’s conclusion that it would have been obvious based on Zakko and
Balbeirz to include openings that are not circular. Therefore, we vacate the
rejection over Zakko, Balbeirz, and de la Rama as duplicative.
SUMMARY
We affirm the obviousness rejections of claims 17 and 18 over
Balbierz and of claims 1, 4, 10, 11, 17, 20, and 21 over Zakko in view of
Balbierz. However, we vacate the obviousness rejection of claims 1 and 20
over Zakko in view of Balbierz and de la Rama. In addition, we reverse the
obviousness rejections of claims 1, 5-7, and 16 over Balbierz and of claim 1
over Balbierz in view of de la Rama, as well as the indefiniteness rejection
of claim 5. Thus, claims 5-7 and 16 are not currently subject to a rejection.
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TIME PERIOD FOR RESPONSE
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

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