Ex Parte O et al

Board of Patent Appeals and Interferences

Oct 15, 2009

10725178 (B.P.A.I. Oct. 15, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte DENNIS O’BRIEN and CARL YEE
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Appeal 2009-005178
Application 10/725,178
Technology Center 3700
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Decided: October 15, 2009
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Before LINDA E. HORNER, STEFAN STAICOVICI, and
KEN B. BARRETT, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Dennis O’Brien et al. (Appellants) appeal under 35 U.S.C. § 134 from
the Examiner’s decision rejecting claims 1-5 and 8-141. We have
jurisdiction over this appeal under 35 U.S.C. § 6 (2002).

THE INVENTION
Appellants’ invention relates to a catheter 20 having a cutting balloon
22 including an inflatable balloon 30, a plurality of incising elements 44
encapsulated in respective mounting pads 46, and a compressible sheath 50
for each incising element 44. Spec. 5, ll. 2-3, 25-26, and 30-31; Spec. 6, ll.
7-9; and figs. 1-3. During transit to the treatment site, sheath members 52a,
52b of sheath 50 protect cutting edge 48 of incising element 44. When
reaching the treatment site, the inflatable balloon 30 expands so that sheath
members 52a, 52b contact tissue 58. Further expansion of the balloon 30
results in radial compression of sheath components 52a, 52b so that cutting
edge 48 is exposed for tissue incision. Spec. 7, ll. 3-13 and fig. 4.
Claim 1 is representative of the claimed invention and reads as
follows:
1. A cutting balloon for use on a medical catheter to incise
tissue at a treatment site in a body vessel of a patient, said
cutting balloon comprising:

1 Claims 15-24 are indicated as allowable by the Examiner. Claims 6
and 7 are objected to by the Examiner as being dependent upon a rejected
base claim and otherwise indicated as being allowable if rewritten in
independent form including all of the limitations of the base claim and any
intervening claim. Final Rejection 7, mailed Oct. 2, 2007. Claims 6, 7, and
15-24 are not part of the instant appeal.

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an elongated balloon defining a longitudinal axis, said
balloon being inflatable from a first deflated
configuration to a second radially expanded
configuration;

an elongated incising element mounted on said balloon
and oriented longitudinally, said incising element having
a length and extending radially from said balloon to an
operative surface feature capable of incising tissue; and

a radially compressible sheath mounted on said balloon
along the length of said incising element and extending
radially from said balloon and beyond said surface
feature when said balloon is in the first configuration to
protect said surface feature during transit to the treatment
site, said sheath being positioned for radial compression
between said tissue and said balloon to expose said
surface feature for tissue incision when said balloon is
inflated into the second configuration.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Vigil US 5,320,634 Jun. 14, 1994
Barath US 5,616,149 Apr. 1, 1997

The following rejections are before us for review:2
The Examiner rejected claims 1, 2, 5, 8, and 10 under 35 U.S.C. §
102(b) as anticipated Barath.
The Examiner rejected claims 11-14 under 35 U.S.C. § 103(a) as
unpatentable over Barath.

2 We note that the Examiner has presented new grounds of rejection
and Appellants have properly responded thereto. Ans. 3 and Reply Br. 1.
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The Examiner rejected claims 3, 4, and 9 under 35 U.S.C. § 103(a) as
unpatentable over Barath and Vigil.

THE ISSUE
Appellants argue that Barath fails to teach a sheath that is “radially
compressed to expose the surface feature for tissue incision,” as required by
independent claim 1. App. Br. 10. Further, Appellants note that in contrast
to the claimed invention, “the cutting edges 6 [of Barath] are exposed by the
inflation of the balloon 2” and not by radial compression of the sheath 17
against the vessel wall. App. Br. 10 and 12.
In response, the Examiner takes the position that:
In Figures 12-13 of Barath, the sheath 17 is shown
being positioned for radial compression between
the tissue 7 and the balloon 2 while also exposing
the surface feature 6. Radial compression of the
sheath 17 may be achieved during inflation of the
balloon, wherein the sheath may be pressed and
held between the tissue and the balloon, while also
exposing the surface features 6, and therefore the
device of Barath reads on this limitation.
Ans. 7.
The Examiner appears to take the position that because the sheath 17
of Barath is positioned between the wall 8 and the inflatable balloon 2, the
sheath 17 constitutes a “radially compressible sheath.” The Examiner
further posits that claim 1 does not require that the exposure of the surface
feature for tissue incision be caused by the radial compression of the sheath.
According to the Examiner, claim 1 merely requires that the sheath 17 of
Barath be positioned for radial compression, that is, be positioned so as to be
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compressed between the balloon and the tissue while also exposing the
surface feature for tissue incision.
Accordingly, the issue before us for consideration in the instant appeal
is whether Appellants have shown that the Examiner erred in determining
that the sheath 17 of Barath constitutes a “radially compressible sheath,” as
called for by claim 1.

SUMMARY OF DECISION
We REVERSE.

PRINCIPLES OF LAW
Claim Construction
When construing claim terminology in the United States Patent and
Trademark Office, claims are to be given their broadest reasonable
interpretation consistent with the specification, reading claim language in
light of the specification as it would be interpreted by one of ordinary skill in
the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir.
2004).
Anticipation
"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 Cal., 814 F.2d 628,
631 (Fed. Cir. 1987).
Inherency
Under principles of inherency, when a reference is silent about an
asserted inherent characteristic, it must be clear that the missing descriptive
matter is necessarily present in the thing described in the reference, and that
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it would be so recognized by persons of ordinary skill. Continental Can Co.
v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991).

OPINION
We begin our analysis by construing the limitation of “a radially
compressible sheath… being positioned for radial compression between said
tissue and said balloon to expose said surface feature for tissue incision
when said balloon is inflated.” As noted above, claims are to be given their
broadest reasonable interpretation consistent with the specification. In this
case, claim 1 requires: (1) a radially compressible sheath (2) positioned for
radial compression between said tissue and said balloon and (3) a surface
feature for tissue incision exposed when the balloon is inflated.
It is our finding that Barath teaches a cutting balloon catheter
including a protective sheath 17 that is positioned between an inflatable
balloon 2 and a vessel wall 7, 8 (tissue), so that as the balloon 2 is inflated
cutting edges 6 (surface feature for tissue incision) are exposed to penetrate
the vessel wall 8 (tissue). Barath, col. 5, ll. 30-34 and fig. 13. Hence, in a
first instance, Barath teaches a sheath 17 that is positioned for radial
compression between the tissue and the balloon, and a surface feature for
tissue incision (cutting edges 6) that is exposed when the balloon is inflated.
However, as shown above, claim 1 also requires a “radially compressible
sheath.” Although we agree with the Examiner that claim 1 does not require
actual radial compression of the sheath (Ans. 7), nonetheless, in order to
satisfy the limitation of claim 1, we find that the sheath 17 of Barath should
be capable of radial compression. However, Barath teaches only that the
protective sheath 17 is positioned between the inflatable balloon 2 and the
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vessel wall 8 (tissue). We could not find any portion, and the Examiner has
not pointed to any portion of Barath, that teaches sheath 17 to be capable of
radial compression. Moreover, the Examiner states that:
Radial compression of the sheath 17 may be
achieved during inflation of the balloon, wherein
the sheath may be pressed and held between the
tissue and the balloon…
Ans. 7 (emphasis added).
Since Barath does not expressly teach that sheath 17 is capable of
radial compression, the Examiner appears to rely on a theory of inherency to
show that Barath anticipates the subject mater of claim 1. “Inherent
anticipation requires that the missing descriptive material is ‘necessarily
present,’ not merely probably or possibly present, in the prior art.” Trintec
Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002)
(quoting In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)). In this case,
the question raised is whether the sheath 17 of Barath is necessarily capable
of radial compression. Figure 13 of Barath specifically shows cutting edges
6 penetrating the vessel wall 8 prior to the radial compression of sheath 17
between balloon 2 and wall 8 (see the space between the sheath 17 and wall
8). 3 In other words, the length of the cutting edges 6 (surface feature for
tissue incision) is such that penetration of the vessel wall due to expansion of
the inflatable balloon occurs before the sheath 17 is radially compressed
between the balloon and the vessel wall. As such, we agree with Appellants

3 In Figure 13 of Barath the reference number “15” appears in error.
The reference number 15 represents a casing shown in a different
embodiment presented in Figures 9 and 10. See also Barath, col. 5, ll. 1-13.
We find that the reference number “15” in Figure 13 represents the sheath
17.
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that the sheath 17 of Barath is not necessarily capable of radial compression,
as the Examiner suggests. See Reply Br. 5. In conclusion, we find that the
Examiner has not provided sufficient evidence to support the finding that
sheath 17 of Barath constitutes a “radially compressible sheath,” as called
for by claim 1.
Inasmuch as we found that Barath does not teach a cutting balloon
having a “radially compressible sheath,” as called for by independent claim
1, Barath does not teach all the elements of independent claim 1.
Accordingly, the rejection of claims 1, 2, 5, 8, and 10 under 35 U.S.C. §
102(b) as anticipated by Barath cannot be sustained.
With respect to claims 11-14, the Examiner’s proposed modification
of the disclosure of Barath (Ans. 5) does not cure the deficiencies of Barath
as discussed above. Accordingly, the rejection of claims 11-14 under 35
U.S.C. § 103(a) as unpatentable over Barath likewise cannot be sustained.
Finally, regarding claims 3, 4, and 9, we find that the application of
Vigil does not cure the deficiency of Barath as discussed above.
Accordingly, the rejection of claims 3, 4, and 9 under 35 U.S.C. § 103(a) as
unpatentable over Barath and Vigil is also reversed.

CONCLUSION
Appellants have shown that the Examiner erred in determining that
the sheath 17 of Barath constitutes a “radially compressible sheath,” as
called for by claim 1.

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DECISION
The Examiner’s decision to reject claims 1-5 and 8-14 is reversed.

REVERSED

mls

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