Ex Parte Holman et al

Board of Patent Appeals and Interferences

Aug 9, 2012

11139253 (B.P.A.I. Aug. 9, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THOMAS J. HOLMAN and JAN WEBER
__________

Appeal 2011-010257
Application 11/139,253
Technology Center 3700
__________

Before JEFFREY N. FREDMAN, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a balloon
catheter medical device. The Examiner rejected the claims as anticipated
and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
“Percutaneous angioplasty makes use of a dilatation balloon catheter,
which is introduced into and advanced through a lumen or body vessel until
the distal end thereof is at a desired location in the vasculature” (Spec. 1, ll.
15-17). The Specification teaches that the balloon is inflated, thereby
“radially compressing the atherosclerotic plaque of any lesion present
against the inside of the artery wall, and/or otherwise treating the afflicted
area of the vessel” (Spec. 1, ll. 20-22).
The Claims
Claims 1-13, 16-19, 22, 24, and 27-31 are on appeal. Claim 1 is
representative and reads as follows:
1. A medical device comprising:
a catheter shaft having a distal portion and a
proximal portion;
an expandable member mounted on the distal
portion of the catheter shaft, the expandable member
comprising a distal end portion, a proximal end portion
and a central portion positioned between the distal end
portion and the proximal end portion, the expandable
member having an expanded state and a contracted state
and being expandable from its contracted state to its
expanded state;
a mesh member comprising a plurality of strands
forming a mesh, the mesh member surrounding the
expandable member, having a first end and a second end,
and being substantially free-floating over the expandable
member, the mesh being in the shape of a spiral, the
mesh having an inner surface facing the catheter shaft,
the inner surface being the entirety of the mesh that is
facing the catheter shaft, wherein, when the expandable
member is in its expanded state, the inner surface of the
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mesh at its greatest distance from the catheter shaft is
disposed radially around the expandable member and the
entirety of the inner surface of the mesh being in contact
with and urged against the expandable member; and
a restraining mechanism associated with the mesh
member, wherein the restraining mechanism
continuously applies a longitudinal biasing force on the
mesh member when the expandable member is in its
expanded state, the restraining mechanism having a first
end fixed to the catheter shaft and second end connected
to the first end of the mesh member, wherein the second
end of the restraining mechanism and the first end of the
mesh member are movable in a longitudinal direction
relative to the catheter shaft and the first end of the
restraining mechanism.

The issues

A. The Examiner rejected claims 1, 2, 19, 22, 28, and 30 under 35 U.S.C.
§ 102(b) as anticipated by Ruiz1 (Ans. 3-6).
B. The Examiner rejected claims 3 and 9-12 under 35 U.S.C. § 103(a) as
obvious over Ruiz and Wholey2 (Ans. 6-7).
C. The Examiner rejected claims 4-6 under 35 U.S.C. § 103(a) as
obvious over Ruiz and Nott3 (Ans. 7-8).
D. The Examiner rejected claims 7 and 24 under 35 U.S.C. § 103(a) as
obvious over Ruiz and Termin4 (Ans. 8-9).
E. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) as obvious
over Ruiz and Douk5 (Ans. 9).

1 Ruiz, C., US 5,868,779, issued Feb. 9, 1999.
2 Wholey et al., US 4,723,549, issued Feb. 9, 1988.
3 Nott et al., US 6,013,093, issued Jan. 11, 2000.
4 Termin et al., US 5,221,261, issued Jun. 22, 1993.
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F. The Examiner rejected claims 13, 16, 29, and 31 under 35 U.S.C. §
103(a) as obvious over Ruiz and Engelson6 (Ans. 9-11).
G. The Examiner rejected claims 17 and 18 under 35 U.S.C. § 103(a) as
obvious over Ruiz and Hillstead7 (Ans. 11-12).
H. The Examiner rejected claim 27 under 35 U.S.C. § 103(a) as obvious
over Ruiz and Dubrul8 (Ans. 12-13).
A. 35 U.S.C. § 102(b) over Ruiz
The Examiner finds that “Ruiz discloses a catheter shaft (11) having
both distal and proximal ends, an expandable member (12) having an
expanded and contracted state that is mounted on the catheter shaft, a mesh
member (14) formed of filaments that free-float around the expandable
member, the mesh being in the shape of a spiral” (Ans. 4). The Examiner
finds that since “the claim fails to preclude two directions, Ruiz anticipates a
mesh having a helical strand in one direction.” (Id. at 13.) The Examiner
finds that the “mesh of Ruiz is formed by helically wrapping a strand in a
first direction and then helically wrapping another strand in a direction
opposite of the first” (id. at 14).
Appellants contend that “the claims recite that the mesh itself is in the
shape of a spiral. The mesh is formed by a plurality of strands, but the claim
does not recite individual strands in the shape of a spiral” (App. Br. 14).
Appellants contend that “Ruiz does not teach or suggest that the mesh itself
is in the shape of a spiral. The Examiner does not point to any language in

5 Douk et al., US 6,818,006 B2, issued Nov. 16, 2004.
6 Engelson et al., US 5,972,019, issued Oct. 26, 1999.
7 Hillstead, R., US 5,116,318, issued May 26, 1992.
8 Dubrul et al., US 6,450,989 B2, issued Sep. 17, 2002.
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support of her conclusion that Ruiz anticipates the claimed invention” (App.
Br. 14).
Appellants contend that “[d]isclosure of a mesh, however, does not
inherently constitute disclosure of a mesh in the shape of a spiral. Regardless
of whether each filament is individually wrapped in the shape of a spiral,
Ruiz does not teach a ‘mesh in the shape of a spiral’ even using the
Examiner's own definition of a mesh” (id. at 15).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Ruiz teaches a “mesh being in the
shape of a spiral” as required by claim 1?
Findings of Fact
1. The Specification teaches that the “mesh 18 may also take the
form of, but not limited to, a coil as shown in figure 17, a coil, wherein
adjacent strand portions 120 are joined, as shown in figure 18” (Spec. 11, ll.
26-28).
2. Figures 17 and 18 of the Specification are reproduced below:

“FIG. 17 is a side view of an embodiment of the mesh of the present
invention mounted on a balloon. FIG. 18 is a side view of an embodiment of
the mesh of the present invention mounted on a balloon” (Spec. 5, ll. 7-10).
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3. Original claims 20 and 21 of the Specification are reproduced
below:
20. The medical device of claim 1, wherein the mesh is in
the shape of a spiral.
21. The medical device of claim 20, wherein adjacent winds
of the spiral are connected.

4. Figure 3 of Ruiz is reproduced below:

“FIG. 3 is a side view of the distal end of the apparatus” (Ruiz, col. 3, l. 33).
5. Ruiz teaches an “[a]pparatus 10 includes catheter 11 having
balloon element 12 and sheath 13 having expandable but non-compliant
mesh 14 disposed over balloon element 12” (Ruiz, col. 3, ll. 55-59).
6. Ruiz teaches that:
Expandable mesh 14 includes rigid retainer ring 15 disposed
from the distal end of expandable mesh 14 that engages
distal end 16 of catheter 11. Rigid retainer ring 15 maintains
expandable mesh 14 aligned with balloon member 12, and
prevents proximal force on retractor knob 23 from pulling
the expandable mesh to a position proximal to balloon
element 12.

(Ruiz, col. 4, ll. 10-16.)
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7. Ruiz teaches that “[p]referably, the cross-points of the mesh are
not interconnected, so that the strands may slide freely over one another
when balloon element 12 is inflated” (Ruiz, col. 5, ll. 7-9).
8. Ruiz teaches that after “balloon element 12 is deflated,
expandable mesh 14 may be returned to its contracted state by pulling
proximally on retractor ring 23” (Ruiz, col. 4, ll. 32-35).
Principles of Law
“It is axiomatic that, in proceedings before the PTO, claims in an
application are to be given their broadest reasonable interpretation consistent
with the specification.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983).
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, Appellants challenge the Examiner's interpretation of
the phrase “the mesh being in the shape of a spiral” as recited in Claim 1,
arguing that “the mesh itself is in the shape of a spiral. The mesh is formed
by a plurality of strands, but the claim does not recite individual strands in
the shape of a spiral” (App. Br. 14). Appellants contend that “[r]egardless of
whether an individual filament of Ruiz is helically wrapped in the shape of a
spiral, the Ruiz mesh itself is not in the shape of a spiral as required by the
claims” (id. at 15).
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During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to determine the meaning of the phrase “the mesh being in the
shape of a spiral.” Appellants do not identify any portion of the
Specification which specifically defines the phrase “the mesh being in the
shape of a spiral.”
The Specification teaches that “the “mesh 18 may also take the form
of, but not limited to, a coil as shown in figure 17, a coil, wherein adjacent
strand portions 120 are joined, as shown in figure 18” (Spec. 11, ll. 26-28;
FF 1). The word “coil” is defined as “a length of something wound or
arranged in a spiral.”9 This interpretation is consistent with Figure 18 of the
Specification, which displays a mesh 18 in a coil wherein adjacent strand
portions 120 are joined (see Fig. 18; FF 2). A careful review of the
Specification only found the word “spiral” in original claims 20 and 21,
where claim 21 further limited “the mesh is in the shape of a spiral”
constraint of claim 20 to require that “adjacent winds of the spiral are
connected” (see Spec. 19, claims 20-21; FF 3).
Thus, when the Specification uses the phrase “the mesh being in the
shape of a spiral” the Specification is reasonably understood as broadly
encompassing meshes which are composed of adjacent coils such as those
shown in Figure 18 of the Specification, where the adjacent coils may or

9 “coil.” Oxford Dictionaries. April 2010 Oxford University Press.
06 August 2012,
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may not be connected at intersection points as in originally filed claim 21
(FF 1-3).
The Examiner finds that Ruiz teaches a “mesh having a shape of a
spiral wherein a curve of right and left handed filaments generate the filter
material and are connected when one filament meets another (Fig. 3)” (Ans.
4).
We conclude that the Examiner has the better position. “[D]uring
patent prosecution when claims can be amended, ambiguities should be
recognized, scope and breadth of language explored, and clarification
imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). We agree with the
Examiner that, when read in light of the Specification, the phrase in claim 1
that “the mesh being in the shape of a spiral” is most reasonably interpreted
as encompassing the mesh of Ruiz shown in Figure 3 (FF 4), which is
virtually indistinguishable from the mesh of Figure 18 of the Specification
(FF 2).
Appellants contend that “Ruiz does not teach or suggest that the mesh
itself is in the shape of a spiral. The Examiner does not point to any
language in support of her conclusion that Ruiz anticipates the claimed
invention” (App. Br. 14). Appellants contend that “[d]isclosure of a mesh,
however, does not inherently constitute disclosure of a mesh in the shape of
a spiral. Regardless of whether each filament is individually wrapped in the
shape of a spiral, Ruiz does not teach a ‘mesh in the shape of a spiral’ even
using the Examiner's own definition of a mesh” (id. at 15).
We are not persuaded. When the phrase “mesh in the shape of a
spiral” is read in light of the teachings of the Specification as discussed
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above, we find it evident that the mesh of Figure 3 of Ruiz satisfies this
limitation equally as well as the mesh of Figure 18 of the Specification. As
Morris notes,
It is the applicants’ burden to precisely define the invention,
not the PTO’s….
The problem in this case is that the [A]ppellants failed
to make their intended meaning explicitly clear. Even
though the [A]ppellants implore us to interpret the claims in
light of the [S]pecification, the [S]pecification fails to set
forth the definition sought by the [A]ppellants.

In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997). To the extent that
Appellants are interpreting the phrase “mesh in the shape of a spiral” as
something other than the meshes disclosed in the Specification, this
interpretation lacks descriptive support in the Specification.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Ruiz
teaches a “mesh being in the shape of a spiral” as required by claim 1.
B. 35 U.S.C. § 103(a) over Ruiz and Wholey
The Examiner finds that “Ruiz discloses all of the limitations
previously discussed except for a restraining mechanism including an elastic
member that is stretched when the expandable member is dilated” (Ans. 6).
The Examiner finds that Wholey teaches “a restraining mechanism having a
plurality of resilient or ‘elastic’ strips (21) of stainless steel that are biased
inward against the catheter and are capable of stretching and springing back”
(id.). The Examiner finds it obvious to “have provided the device of Ruiz
with an elastic restraining mechanism, as taught by Wholey et al., to
maneuver the inflation and deflation of the expandable member” (id. at 7).
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The Examiner provides sound fact-based reasoning for combining
Wholey with Ruiz. We adopt the fact finding and analysis of the Examiner
as our own. Appellants argue the underlying obviousness rejection over
Ruiz, but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Wholey with Ruiz. Since Appellants only argue the
underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
C. 35 U.S.C. § 103(a) over Ruiz and Nott
The Examiner finds that “Ruiz fails to disclose first junctures wherein
the crossing strands are fixed” (Ans. 7). The Examiner finds that Nott
teaches “a filter mesh having strands (310) with first junctures and second
junctures wherein first junctures of strands (310) are joined at nodes III and
are not free to move relative to one another” (id.). The Examiner finds it
obvious to “have provided both first and second junctures to the
fiber mesh of Ruiz, as taught by Nott et al., to maintain the structure of the
mesh while having a degree of sliding self-adjustability when compressed or
expanded to conform to various size vessels” (id. at 8).
The Examiner provides sound fact-based reasoning for combining
Nott with Ruiz. We adopt the fact finding and analysis of the Examiner as
our own. Appellants argue the underlying obviousness rejection over Ruiz,
but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Nott with Ruiz. Since Appellants only argue the
underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.

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D. 35 U.S.C. § 103(a) over Ruiz and Termin
The Examiner finds that “Ruiz discloses all of the limitations
previously discussed except for a mesh member formed of inelastic
material” (Ans. 8). The Examiner finds that Termin teaches “a balloon or
‘expandable member’ (82) surrounded by a fixation element or ‘mesh’ (90)
having an inelastic open weave constructed of plastically deformable
material” (id.). The Examiner finds it obvious to “have constructed the
mesh of Ruiz of inelastic material, as taught by Termin et al., to eliminate a
restoring force and retain the expanded shape of the mesh” (id. at 9).
The Examiner provides sound fact-based reasoning for combining
Termin with Ruiz. We adopt the fact finding and analysis of the Examiner as
our own. Appellants argue the underlying obviousness rejection over Ruiz,
but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Termin with Ruiz. Since Appellants only argue the
underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
E. 35 U.S.C. § 103(a) over Ruiz and Douk
The Examiner finds that “Ruiz discloses an expandable member (12)
that expands the mesh member (14)” (id.). The Examiner finds that Douk
teaches “a loadable spring (87) that is attached to a ‘catheter shaft’
(55), wherein the spring is connected to the first end of a mesh member (25)
such that the spring is capable of taking a load and applying a longitudinal
force on the mesh member to assist in its expansion” (id.). The Examiner
finds it obvious to “have provided the device of Ruiz with a loadable spring,
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as taught by Douk et al., to provide aid in the expansion of the mesh
member” (Ans. 9).
The Examiner provides sound fact-based reasoning for combining
Douk with Ruiz. We adopt the fact finding and analysis of the Examiner as
our own. Appellants argue the underlying obviousness rejection over Ruiz,
but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Douk with Ruiz. Since Appellants only argue the
underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
F. 35 U.S.C. § 103(a) over Ruiz and Engelson
The Examiner finds that “Ruiz fails to disclose a retracting
mechanism including a pull back mechanism having a plurality of pull wires
that are connected to the sliding member and controlled by the manifold”
(id. at 10). The Examiner finds that Engelson teaches “a pull-back
mechanism including a proximal sliding member (312) that slides axially on
the ‘catheter shaft’ (310) and wherein pull-back wires (316) are connected to
the catheter shaft and to the sliding member” (id. at 11). The Examiner finds
it obvious to “have provided the proximal end of the catheter shaft of Ruiz,
as taught by Engelson et al., to control and maneuver the necessary amount
of expansion to dilate the tissue” (id.).
The Examiner provides sound fact-based reasoning for combining
Engelson with Ruiz. We adopt the fact finding and analysis of the Examiner
as our own. Appellants argue the underlying obviousness rejection over
Ruiz, but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Engelson with Ruiz. Since Appellants only argue
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the underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
G. 35 U.S.C. § 103(a) over Ruiz and Hillstead
The Examiner finds that “Ruiz discloses all of the limitations
previously discussed except for an implantable medical device that
surrounds the mesh as well as the expandable member” (Ans. 11). The
Examiner finds that “Hillstead teaches an implantable medical device, i.e. a
stent, that is placed around an elastic sleeve in which the balloon is
positioned” (id. at 12). The Examiner finds it obvious to “have provided a
stent to the device of Ruiz, as taught by Hillstead, to enable the expandable
member to withstand greater inflation pressures due to the reinforcing effect
of the mesh member” (id.).
The Examiner provides sound fact-based reasoning for combining
Hillstead with Ruiz. We adopt the fact finding and analysis of the Examiner
as our own. Appellants argue the underlying obviousness rejection over
Ruiz, but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Hillstead with Ruiz. Since Appellants only argue
the underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
H. 35 U.S.C. § 103(a) over Ruiz and Dubrul
The Examiner finds that “Ruiz fails to disclose a mesh having plastic
deforming strands and elastic strands” (id. at 13). The Examiner finds that
Dubrul teaches “a catheter having a mesh member (7) that covers an
expandable member (4) wherein the mesh member is formed of non-elastic
filaments that may have some elastic filaments interwoven therein” (id.).
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The Examiner finds it obvious to “have incorporated both elastic and
inelastic strands in the woven mesh of Ruiz, as taught by Dubrul et al., to
create certain characteristics such that the materials of the mesh will have
sufficient strength to retain its expanded condition in the lumen” (id.).
The Examiner provides sound fact-based reasoning for combining
Dubrul with Ruiz. We adopt the fact finding and analysis of the Examiner as
our own. Appellants argue the underlying obviousness rejection over Ruiz,
but Appellants do not identify any material defect in the Examiner’s
reasoning for combining Dubrul with Ruiz. Since Appellants only argue the
underlying rejection of Ruiz which we affirmed above, we affirm this
rejection for the reasons stated by the Examiner.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
102(b) as anticipated by Ruiz. Pursuant to 37 C.F.R. § 41.37(c)(1), we also
affirm the rejection of claims 2, 19, 22, 28, and 30 as these claims were not
argued separately.
We also affirm the rejections of
 claims 3 and 9-12 under 35 U.S.C. § 103(a) as obvious over Ruiz and
Wholey.
 claims 4-6 under 35 U.S.C. § 103(a) as obvious over Ruiz and Nott.
 claims 7 and 24 under 35 U.S.C. § 103(a) as obvious over Ruiz and
Termin.
 claim 8 under 35 U.S.C. § 103(a) as obvious over Ruiz and Douk.
 claims 13, 16, 29, and 31 under 35 U.S.C. § 103(a) as obvious over
Ruiz and Engelson.
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 claims 17 and 18 under 35 U.S.C. § 103(a) as obvious over Ruiz and
Hillstead.
 claim 27 under 35 U.S.C. § 103(a) as obvious over Ruiz and Dubrul.

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

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