Ex Parte Goodin et al

Board of Patent Appeals and Interferences

Sep 28, 2009

10340406 (B.P.A.I. Sep. 28, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte RICHARD GOODIN and ROBERT E. BURGMEIER
____________

Appeal 2009-005407
Application 10/340,4061
Technology Center 3700
____________

Decided: September 28, 2009
____________

Before SCOTT R. BOALICK, JOHN C. KERINS, and
STEFAN STAICOVICI, Administrative Patent Judges.

BOALICK, Administrative Patent Judge.

DECISION ON APPEAL

1 Application filed January 9, 2003. The real party in interest is Boston
Scientific Scimed, Inc.
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This is an appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1-9 and 11-20, all the claims pending in the application. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

STATEMENT OF THE CASE
Appellants’ invention relates to a catheter for crossing an occluding
lesion with an inflatable balloon and dilating the lesion. (Spec. Abstract.)
The catheter includes an inner tube, a balloon bonded to the inner tube and a
plurality of rigid ribs spaced around the circumference of the balloon near
the distal end of the catheter. (Spec. Abstract.)

Claims 1 and 9 are exemplary:
1. A catheter for dilating a lesion in a vascular conduit of a
patient, said catheter comprising:

an inner tube;

an inflatable balloon, the inflatable balloon having a diameter, a first
inflation state and a second inflation state, the inflatable balloon having a
distal section attached to said inner tube, in the first inflation state and in the
second inflation state the diameter of the distal section being substantially
the same; and

at least one rib having a first end attached to said distal section of said
balloon and a second end attached to said balloon at a location proximal to
said distal section, said location being within a region of the balloon wherein
in the second inflation state the diameter is greater than in the first inflation
state, each said rib for penetrating the lesion to position said balloon for
dilation of the lesion.

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9. A catheter for dilating a lesion in a vascular conduit of a
patient, said catheter comprising:

an inner tube defining a longitudinal axis;

an inflatable balloon mounted on said inner tube, said balloon
extending from a proximal end to a distal end; and

a dilatation unit having a plurality of ribs with each said rib extending
from a first end to a second end and wherein said first end is distanced from
said longitudinal axis at a radial distance dl and said second end distanced
from said longitudinal axis at a radial distance d2 with dl < d2, wherein each
said rib comprises a first elongated portion aligned substantially parallel
with said longitudinal axis and a second elongated portion extending from
said first portion and at an angle, α, thereto.

The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Burbank 6,758,848 B2 July 6, 2004
(filed June 21, 2002)
Lary 6,951,566 B2 Oct. 4, 2005
(filed Dec. 27, 2002)

Claims 1-4, 6-9, 11 and 13-202 stand rejected under 35 U.S.C.
§ 102(e) as being anticipated by Lary.
Claims 5 and 12 stand rejected under 35 U.S.C. § 103(a) as being
obvious over Lary and Burbank.
Only those arguments actually made by Appellants have been
considered in this decision. Arguments that Appellants did not make in the

2 The Examiner’s Answer omits claims 3, 4 and 13 from the heading of the
rejection (Ans. 3), but addresses these claims in the body of the rejection
(Ans. 4, 5).
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Briefs have not been considered and are deemed to be waived. See 37
C.F.R. § 41.37(c)(1)(vii).

ISSUES
With respect to independent claim 1, Appellants argue that Lary does
not teach the limitation “in the first inflation state and in the second inflation
state the diameter of the distal section being substantially the same.” (App.
Br. 9-14; see also Reply Br. 2.) Appellants present similar arguments
regarding independent claim 16, which recites similar limitations. (App.
Br. 17.)
With respect to independent claim 9, Appellants argue that Lary does
not teach the limitation, “wherein each said rib comprises a first elongated
portion aligned substantially parallel with said longitudinal axis and a
second elongated portion extending from said first portion and at an angle, α,
thereto.” (App. Br. 14; see also App. Br. 15-17, Reply Br. 2-3.)
Appellants’ arguments present the following issue:
Have Appellants shown that the Examiner erred in rejecting
claims 1-4, 6-9, 11 and 13-20 under 35 U.S.C. § 102(e)?
The resolution of this issue turns on the following subsidiary issues:
1. Have Appellants shown that the Examiner erred in finding that
Lary teaches the limitation “in the first inflation state and in the second
inflation state the diameter of the distal section being substantially the
same,” as recited in independent claim 1?
2. Have Appellants shown that the Examiner erred in finding that
Lary teaches the limitation “wherein each said rib comprises a first
elongated portion aligned substantially parallel with said longitudinal axis
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and a second elongated portion extending from said first portion and at an
angle, α, thereto,” as recited in independent claim 9?

FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.

Lary
1. Lary relates “to surgical instruments for removing an obstruction in,
or for enlarging the orifice of a vascular conduit or connective duct.”
(Col. 1, ll. 14-16.) In one embodiment, Lary discloses an
apparatus 10 “for incising and dilating a stenosis within a vascular
conduit.” (Col. 4, ll. 55-57; Fig. 2.)

2. The apparatus 10 includes an inflatable balloon 14 (col. 4, ll. 66-67),
an elongated tubular catheter 20 (col. 5, l. 1), incising blades 22a-d
attached to an external surface 24 of the inflatable balloon 14 (col. 5,
ll. 4-6) and a guidewire 26 (col. 5, ll. 8-9). As illustrated in Figure 2,
“the distal end of the apparatus 10 is shown to include an inflatable
balloon 14 that is attached to the distal end 18 of an elongated tubular
catheter 20.” (Col. 4, l. 66 to col. 5, l. 1; Fig. 2.) For the embodiment
of Figures 2 and 3, “the balloon 14 is conically shaped” in a tapered
section 34. (Col. 5, ll. 18-19.) Figure 3 illustrates that the incising
blades 22a-d have a straight configuration and are “formed with a
substantially straight cutting edge 40” on the blades 22a-d (col. 5,
ll. 35-36; fig. 3).
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3. Lary describes another embodiment of an apparatus 110 with “a
balloon 114 having a non-conical tapered section 134.” (Col. 6,
ll. 2-4; figs. 6A, 6B.) An “external surface 124 of the tapered
section 134 is shaped as a surface of revolution defined by the rotation
of a curve about the longitudinal axis 128.” (Col. 6, ll. 7-9; Fig. 6B.)
Figure 6A of Lary illustrates a relatively small space between a distal
end 138 of incising blades 122a-c and a distal end 118 of a
catheter 120 when the balloon 114 is deflated. Figure 6B of Lary
illustrates that the distal end 138 of incising blades 122a-c contacts the
distal end 118 of the catheter 120 when the balloon 114 is inflated.
Figures 6A and 6B illustrate that the incising blades 122a-c have a
curved configuration with “cutting edges 140 that are continuously
curved from the distal end 138 to the proximal end 136” (col. 6,
ll. 10-12).

Specification
4. Figure 4 of Appellants’ Specification illustrates that “the balloon 14 is
collapsed into the deflated configuration.” (Spec. 8:8-9.) In Figure 5,
“the balloon 14 can be partially inflated once the ribs 24 have been
partially or totally embedded into the lesion 66 to assist in the creation
of the passageway.” (Spec. 8:19-21.)

5. Appellants’ Specification describes a rib 24f as having an elongated
first portion 54, an elongated second portion 56 (Spec. 7: 12-15;
Fig. 3) and a distal end 58 (Spec. 7:20-21; Fig. 3). Figures 2 and 3
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illustrate that the first elongated portion 54 is a portion of the body of
the rib 24f.

PRINCIPLES OF LAW
Anticipation is established when a single prior art reference discloses,
expressly or under the principles of inherency, each and every limitation of
the claimed invention. Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342,
1347 (Fed. Cir. 1999); In re Paulsen, 30 F.3d 1475, 1478-79
(Fed. Cir. 1994).
During examination of a patent application, a claim is given its
broadest reasonable construction consistent with the specification. In re
Prater, 415 F.2d 1393, 1404-05 (CCPA 1969). “[T]he words of a claim ‘are
generally given their ordinary and customary meaning.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal citations
omitted). The “ordinary and customary meaning of a claim term is the
meaning that the term would have to a person of ordinary skill in the art in
question at the time of the invention, i.e., as of the effective filing date of the
patent application.” Id. at 1313.

ANALYSIS
We find Appellants’ arguments that the Examiner erred in rejecting
claims 1-4, 6-8 and 16-20 under 35 U.S.C. § 102(e) and erred in rejecting
claim 5 under 35 U.S.C. § 103(a) to lack merit. However, we agree with
Appellants that the Examiner erred in rejecting claims 9, 11 and 13-15 under
35 U.S.C. § 102(e) and erred in rejecting claim 12 under 35 U.S.C. § 103(a).

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Claims 1-4 and 6-8
Appellants’ arguments (App. Br. 9-14) that Lary does not teach the
limitation “in the first inflation state and in the second inflation state the
diameter of the distal section being substantially the same,” as recited in
independent claim 1, are not persuasive.
The Examiner found that Lary teaches “in the first inflation state and
in the second inflation state the diameter of the distal section being
substantially the same,” because “the ribs (22a) [of Lary] move only a small
amount between a first and second inflation state” and “the claim does not
specify the extent of inflation for each state.” (Ans. 3.) The Examiner
further found that “that the term ‘substantially’ is a broad term . . . even
though it [the diameter] may not be ‘the same’ in both the first and second
inflation states, it is ‘substantially the same.’” (Ans. 8.)
Under the broadest reasonable interpretation consistent with the
Specification, we agree with the Examiner that Lary teaches the limitation
“the diameter of the distal section being substantially the same.” The
Specification does not provide any special meaning for the term
“substantially.” The relevant plain meaning of “substantially” is “largely but
not wholly that which is specified.” Webster’s Ninth New Collegiate
Dictionary 1176 (9th ed. 1983).
Figure 6A of Lary illustrates a relatively small space between a distal
end 138 of incising blades 122a-c and a distal end 118 of a catheter 120
when a balloon 114 is deflated. (FF 3.) Figure 6B of Lary illustrates that
the distal end 138 (shown in Fig. 6A) of incising blades 122a-c contacts the
distal end 118 of the catheter 120 when the balloon 114 is inflated. (Id.) In
comparing Figures 6A and 6B, a diameter of the balloon 114 at the distal
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end 138 of incising blades 122a-c changes a relatively small amount when
the balloon 114 is inflated. (See id.) Thus, as the balloon 114 is inflated, we
find that the diameter of the balloon 114 at the distal end 138 of incising
blades 122a-c is “substantially the same” because the diameter, when in this
inflation state, is “largely but not wholly” the same as the diameter when in
the former inflation state. Thus, we find the Examiner’s construction of
“substantially the same” to be reasonable.
Moreover, under the broadest reasonable interpretation consistent with
the Specification, we agree with the Examiner that by merely reciting a “first
inflation state” and a “second inflation state”, claim 1 “does not specify the
extent of inflation for each state” (Ans. 8). Appellants’ Specification teaches
several distinct inflation states for a balloon 14, including a “collapsed . . .
deflated configuration,” as illustrated in Figure 4, and a “partially inflated”
configuration, as illustrated in Figure 5. (FF 4.) Thus, the claimed “first
inflation state” can be reasonably interpreted as the “collapsed . . . deflated
configuration” of Figure 4; and the claimed “second inflation state” can be
reasonably interpreted as the “partially inflated” configuration of Figure 5.
(See id.) Therefore, when the balloon 114 of Lary is expanded from a “first
inflation state” (i.e., deflated configuration) to a “second inflation state” (i.e.,
partially inflated configuration) a diameter of the balloon 114 at the distal
end 138 of incising blades 122a-c is “substantially the same.” Appellants
have not pointed to any special definition of a “first inflation state” or a
“second inflation state” in the Specification that would require a different
interpretation.
Furthermore, Lary teaches that “the distal end of the apparatus 10 is
shown to include an inflatable balloon 14 that is attached to the distal end 18
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of an elongated tubular catheter 20.” (FF 2.) Thus, a diameter of the
balloon 14 in the region where the balloon 14 is attached to the distal end 18
would remain “substantially the same” regardless of the inflation state of the
balloon 14.
Appellants argue that, in reference to the Specification, “the distance
from the longitudinal axis to any point along the distal section 32 of [the]
balloon 14 remains essentially unchanged” because the distal section 32 of
the balloon 14 is “sandwiched” between the ribs 24 and the inner tube 20
(App. Br. 11) and a first portion 54 of a rib 24f is substantially parallel to a
longitudinal axis 22 (App. Br. 11-12). However, these structural features are
not claimed. Appellants also argue that because claim 1 recites “the
diameter of the distal section being substantially the same” then “there is
essentially no inflation in the distal section for either state.” (App. Br. 13.)
However, the feature of “no inflation in the distal section” is not claimed.
Therefore, Appellants have not shown that the Examiner erred in
finding that Lary teaches “in the first inflation state and in the second
inflation state the diameter of the distal section being substantially the
same,” as recited in claim 1.
We conclude that Appellants have not shown that the Examiner erred
in rejecting claim 1 under 35 U.S.C. § 102(e). Because Appellants have not
presented arguments regarding claims 2-4 and 6-8, we affirm the rejection of
these claims under 35 U.S.C. § 102(e) for the same reasons as for claim 1,
from which they depend.

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Claims 9, 11 and 13-15
Appellants’ arguments (App. Br. 14-17) that Lary does not teach the
limitation “wherein each said rib comprises a first elongated portion aligned
substantially parallel with said longitudinal axis and a second elongated
portion extending from said first portion and at an angle, α, thereto,” as
recited in independent claim 9, are persuasive.
The Examiner found that Lary teaches “each said rib comprises a first
elongated portion aligned substantially parallel with said longitudinal axis”
because Figure 2 of Lary illustrates that the end portions of the blades 22a-d
contacting the distal end 18 of the catheter 20 are parallel to the longitudinal
axis of the catheter 20. (Ans. 9.) The Examiner also found that the portion
of the blades 22a-d extending along the balloon 14 corresponds to “a second
elongated portion extending from said first portion and at an angle, α,
thereto.” (Ans. 5, 9.)
We do not agree with the Examiner’s claim construction. Appellants’
Specification consistently describes and illustrates the ribs 24 (e.g., rib 24f)
as having an elongated first portion 54, an elongated second portion 56 and a
distal end 58. (FF 5.) Appellants’ Figures 2 and 3 illustrate that the first
elongated portion 54 is a portion of the body of the rib 24f and distinguishes
between the first elongated portion 54 and the distal end 58 (i.e., the front
edge) of the rib 24f. (Id.) Persons of ordinary skill in the art would thus
understand that there is a distinction between the distal end and the
elongated first portion of the rib, and we therefore find the Examiner’s
interpretation of “first elongated portion” as encompassing a front edge of
Lary’s blades 22a-d to be unreasonable and inconsistent with the
Specification. Furthermore, Lary’s Figures 2, 6A and 6B illustrate that the
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blades 22a-d/122a-c have either a straight or curved configuration (i.e., non-
angled) (FF 2-3), rather than having “a second elongated portion extending
from said first portion and at an angle, α, thereto.”
Therefore, Appellants have shown that the Examiner erred in finding
that Lary teaches “wherein each said rib comprises a first elongated portion
aligned substantially parallel with said longitudinal axis and a second
elongated portion extending from said first portion and at an angle, α,
thereto,” as recited in claim 9.
We conclude that Appellants have shown that the Examiner erred in
rejecting claim 9 as well as claims 11 and 13-15, which depend from claim
9, under 35 U.S.C. § 102(e).

Claims 16-20
Appellants’ arguments (App. Br. 17) that Lary does not teach the
limitation “in the first inflation state and in the second inflation state the
diameter of the distal section being substantially the same,” as recited in
independent claim 16, are not persuasive.
Similar to the previous discussion of claim 1, we agree with the
Examiner that Lary teaches the limitation “in the first inflation state and in
the second inflation state the diameter of the distal section being
substantially the same,” as recited in independent claim 16.
Therefore, Appellants have not shown that the Examiner erred in
finding that Lary teaches “in the first inflation state and in the second
inflation state the diameter of the distal section being substantially the
same,” as recited in independent claim 16.
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We conclude that Appellants have not shown that the Examiner erred
in rejecting claim 16 under 35 U.S.C. § 102(e). Because Appellants have
not presented arguments regarding claims 17-20, we affirm the rejection of
these claims under 35 U.S.C. § 102(e) for the same reasons as claim 16,
from which they depend.

Claims 5 and 12
Although Appellants nominally argue the rejection of dependent
claim 5 separately (App. Br. 18), the arguments presented do not point out
with particularity or explain why the limitations of the dependent claim is
separately patentable. Instead, Appellants summarily allege that claim 5 is
nonobvious because Lary does not teach the same limitations as discussed
above with respect to claim 1and “Burbank . . . does nothing to address the
failure of Lary to teach or suggest all of the elements of independent
claim 1.” (App. Br. 18.) Because Appellants have not persuasively rebutted
the Examiner’s prima facie case of obviousness for dependent claim 5 based
on the teachings of Lary and Burbank, we will sustain the rejection of
claim 5 for the reasons discussed with respect to independent claim 1, from
which claim 5 depends.
However, Appellants have shown error in the rejection of claim 12 for
the reasons discussed above regarding claim 9, from which claim 12
depends. While Appellants also have not presented any substantive
arguments for the patentability of claim 12, instead relying on the same
arguments as presented for claim 9, Burbank has not been relied on by the
Examiner for any teachings that would overcome the deficiencies of Lary in
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disclosing or rendering obvious the subject matter of claim 12. We will not
sustain the rejection of claim 12.

CONCLUSION
Based on the findings of fact and analysis above, we conclude that:
(1) Appellants have not shown that the Examiner erred in rejecting
claims 1-4, 6-8 and 16-20 under 35 U.S.C. § 102(e);
(2) Appellants have shown that the Examiner erred in rejecting
claims 9, 11 and 13-15 under 35 U.S.C. § 102(e);
(3) Appellants have not shown that the Examiner erred in rejecting
claim 5 under 35 U.S.C. § 103(a); and
(4) Appellants have shown that the Examiner erred in rejecting
claim 12 under 35 U.S.C. § 103(a).

DECISION
The rejection of claims 1-4, 6-8 and 16-20 under 35 U.S.C. § 102(e) is
affirmed.
The rejection of claims 9, 11 and 13-15 under 35 U.S.C. § 102(e) is
reversed.
The rejection of claim 5 under 35 U.S.C. § 103(a) is affirmed.
The rejection of claim 12 under 35 U.S.C. § 103(a) is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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