Ex Parte Schaeffer et al

Patent Trial and Appeal Board

Sep 19, 2014

10984417 (P.T.A.B. Sep. 19, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/984,417 11/08/2004 Darin G. Schaeffer 12730-28 (PA-5447-RF6) 3490
48003 7590 09/19/2014
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
HUGHES, SAMUEL T
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
09/19/2014 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DARIN G. SCHAEFFER, MICHAEL C. HOFFA,
SCOTT E. BOATMAN, and KIM ROBERTS
__________

Appeal 2012-007198
Application 10/984,417
Technology Center 3700
__________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a stent
graft system for intraluminal deployment in an aorta and a branch vessel.
The Examiner rejected the claims as obvious and provisionally for non-
statutory double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the provisional non-statutory double patenting rejection, but
reverse the obviousness rejection.

1 Appellants identify the Real Party in Interest as Cook
Incorporated (see App. Br. 1).
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Application 10/984,417

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Statement of the Case
Background
“[A]n aortic wall can weaken, resulting in an aneurysm. Upon further
exposure to hemodynamic forces, such an aneurysm can rupture” (Spec. 1
¶ 3). “A bifurcated stent graft, one example of an endoluminal prosthesis, is
known for use in treating abdominal aortic aneurysms” (Spec. 2 ¶ 5).
“When treating a vessel with an endoluminal prosthesis, it may . . . be
preferable to preserve the original circulation by providing a prosthetic
branch that extends from the prosthesis to a side branch vessel so that the
blood flow into the branch vessel is not impeded” (Spec. 4 ¶ 13).
The Claims
Claims 1–4, 6–8, 12, 14–19, and 27–30 are on appeal. Claim 1 is
representative and reads as follows:
1. A stent graft system for intraluminal deployment in an aorta
and a branch vessel comprising:
an aorta stent graft for deployment within the aorta and defining
a lumen for the passage of blood therethrough, and having a
fenestration positioned and sized so as to allow blood to flow to a
contiguous branch vessel;
a branch vessel prosthesis having a tubular portion and a flaring
portion, such that, when deployed, the flaring portion is located within
the lumen of the aorta stent graft and the tubular portion passes
through the fenestration and into the branch vessel;
a balloon expansion catheter having first and second balloons,
wherein the first balloon is aligned substantially with the flaring
portion and the second balloon is aligned substantially with the
tubular portion such that inflation of the first balloon flares the flaring
portion and inflation of the second balloon expands the tubular
portion, and
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wherein the second balloon is less compliant than the first
balloon.
The issues2
A. The Examiner rejected claims 1–4, 6–8, 12, 14–19, and 27–30 under
35 U.S.C. § 103(a) as obvious over Vardi,3 Goodin,4 and Lam5 (Ans. 4–7).
B. The Examiner rejected claims 1, 6–8, 12, 16–19, and 27–30 on the
ground of provisional nonstatutory obviousness-type double patenting as
being unpatentable over claims 1, 3, 6, 7, 10, 13, and 15 of copending
Application No. 11/547,020 in view of Vardi (Ans. 9–10).
C. The Examiner rejected claims 2–4, 14, and 15 on the ground of
provisional nonstatutory obviousness-type double patenting as being
unpatentable over claims 1, 3, 6, 7, 10, 13, and 15 of copending Application
No. 11/547,020 in view of Vardi and Lam (Ans. 10–11).
A. 35 U.S.C. § 103(a) over Vardi, Goodin, and Lam
The Examiner finds that Vardi discloses “a stent graft system for
intraluminal deployment in an aorta and a branch vessel” but “Vardi does
not disclose that the balloon for deploying the branch prosthesis has a first
balloon and a second balloon wherein the [second] balloon is less compliant
than the first” (Ans. 4–5). The Examiner finds that Goodin teaches a
“hybrid balloon for delivering a stent having a compliant first balloon (34)
and a non-compliant second balloon (32) where the second balloon is less

2 We note that the provisional double patenting rejection over US
application 10/984,167 is moot in view of the abandonment of that
application on Jan. 14, 2011.
3 Vardi et al., US 6,706,062 B2, issued Mar. 16, 2004.
4 Goodin et al., US 5,980,531, issued Nov. 9, 1999.
5 Lam, S., US 5,607,444, issued Mar. 4, 1997.
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compliant (C2:L16-21) with the first balloon providing for deploying the
stent and the second balloon providing for setting or fixing the stent in
place” (Ans. 5). The Examiner concludes that it would have been obvious to
“incorporate a dual balloon system taught by Goodin into the system of
Vardi in order to provide for an effective way to deploy and properly seat
the branch vessel prosthesis” (Ans. 6).
The Examiner acknowledges that “Vardi does not explicitly state that
the first balloon is capable of flaring the flaring portion . . . nor does Vardi
disclose the step of inflating the first balloon to flare the flaring portion of
the balloon” (Ans. 6). The Examiner finds that “Lam teaches delivering an
ostial stent on a balloon catheter where the stent can be self expandable,
have self expandable portions or be balloon expandable” (Ans. 6–7). The
Examiner concludes that it would have been obvious “to incorporate a
balloon expandable flaring portion into the Vardi stent in place of the self
expandable portion since the two structures are recognized equivalents and
since substitution of one known element for another would have yielded
predictable results” (Ans. 7).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Vardi, Goodin, and Lam
render the claims obvious?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Vardi teaches “a stent apparatus with a main tubular stent body
having at least one side opening which may further comprise an extendable
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or second stent inserted through the side opening and at least partly in
registry with the wall of the side opening” (Vardi, col. 3, ll. 11–15).
2. Vardi teaches that “the expandable portion may be covered with
a fabric or the entire stent structure membrane to help form the transition
between the main body lumen and the lumen of the second stent” (Vardi,
col. 3, ll. 42–45).
3. Figures 6C–6G of Vardi are reproduced below:

FIG. 6c is a schematic depiction of the deployment of
the branch stent over the side branch guidewire, through one
of the side openings in the main stent and into the branch
vessel of the subject.
FIG. 6d is a schematic depiction of the removal of the
protective sheath of the branch stent allowing for full
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expansion of the contacting portion prior to final placement
and deployment.
FIG. 6e is a schematic depiction of the compressed
branch stent positioned into the branch by the catheter with
the contacting portion at least partly contacting the side
opening in the main stent, but prior to full expansion of the
branch stent.
FIG. 6f is a schematic depiction of the fully expanded
main stent and the fully positioned and expanded branch
stent, where the branch stent is being dilated by inflation of
a balloon.
FIG. 6g is a schematic depiction of the fully expanded
bifurcating double stent of the invention, positioned into the
bifurcation point in a subject vessel.

(Vardi, col. 5, ll. 48–67.)
4. Figure 13G of Vardi is reproduced below:

A “secondary stent 600 may be introduced as illustrated in FIG[]. 13G . . .
The stent 600 is introduced over a balloon 702 on balloon catheter 700”
(Vardi, col. 12, ll. 18–20).
5. Vardi teaches that:
In the bifurcating double-stent apparatus 10 of the
invention, once the main stent 12 is dilated and the
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stabilizing catheter 44 (as shown in FIG. 6b) is removed, the
branch stent 15 is inserted over the branch guidewire 36 and
through the opening 16 of the main stent 12 substantially as
shown in FIG. 6c, and affixed in place by withdrawal of the
protective sheath 34 (FIG. 6d) and insertion of the branch
stent 15 until it at least partially contacts the perimeter of the
opening 16 of the main stent 12 by the expansion of the
contacting portions 18 which are positioned at the proximal
end 30 of the expandable stent, as shown in FIG. 6e. The
branch stent 15, once positioned in the branch vessel 7, may
be then fully expanded by the balloon 25, as shown in FIG.
6f.

(Vardi, col. 7, ll. 48–61.)
6. Goodin teaches “deploying a stent to a treatment site in a vessel
[which] . . . includes two balloons, one being compliant and used for stent
deployment at a relatively low pressure, and the other being non-compliant
and available for post-deployment stent expansion at a relatively high
pressure” (Goodin, col. 1, ll. 6–12).
7. Goodin teaches that “system 10 also includes a first or inner
balloon 32, a second or outer balloon 34 and an expandable stent 36. The
first, or inner, balloon 32 is preferably formed from a non-compliant
material, and the outer balloon 34 is preferably formed from a compliant
type material” (Goodin, col. 2, ll. 16–21).
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8. Figures 6 and 7 of Goodin are reproduced below:

“The outer balloon 34 is inflated to deploy the stent, as shown in FIG. 6.
The outer balloon 34 is then deflated and the inner or first balloon is then
inflated (as shown in FIG. 7) to ‘set’ or fix the stent 36 in place” (Goodin,
col. 3, ll. 40–42).
9. Goodin teaches that the “inner balloon is then deflated and the
stent delivery system (less the stent 36) is removed from the vessel, leaving
the stent in place. The outer balloon is preferably of a softer and tougher
material than the inner balloon, protecting the inner balloon from damage”
(Goodin, col. 3, ll. 43–47).
10. Lam teaches that:
Where the ostial stent 20 properly “caps” the ostium 30 to
the diseased portion of the bifurcated vessel 21, the flaring
portion 25 substantially conforms to the vessel walls 41
comprising the bifurcation 22, thereby allowing for
unobstructed flow of blood through the bifurcated vessel. . .
.
It is also contemplated that expansion and
deformation of the ostial stent 20 can be accomplished
through the use of a series of various sized and shaped
balloons or by means of bi-balloon 42 or tri-balloon 43
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catheter structures where the various sections of the balloon
catheter act to carry the ostial stent 20, seat the tubular body
24 and deform the flaring portion

(Lam, col. 7, ll. 6–26).
Principles of Law
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with 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). Claim language,
however, “should not [be] treated as meaningless.” Bicon, Inc. v. Straumann
Co., 441 F.3d 945, 951 (Fed. Cir. 2006).
Analysis
Appellants contend that “it is clear that the Goodin’s outer balloon 34
and inner balloon 32 both inflate the entire stent 36 and the same vessel
segment, just at different times. There is no remote suggestion in Goodin
that separate balloons expand different portions of a prosthesis at different
pressures” (App. Br. 14). Appellants further contend that
[T]here is clearly no teaching, suggestion or incentive in the
Goodin reference that would have led one of ordinary skill
in the art to modify Vardi or Lam accordingly, i.e., to make
a second balloon aligned with the tubular portion of a branch
vessel prosthesis less compliant than a first balloon aligned
with the flaring portion.

(App. Br. 14–15.)
The Examiner finds that “the claim does not require that the first
balloon be aligned substantially with only a flaring portion and inflation of
that balloon flares only the flaring portion” (Ans. 11). The Examiner finds
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that the “fact that the references disclose additional structure not required by
Appellant’s invention (i.e. a first balloon that also is aligned with and
expands the tubular portion) is irrelevant. The same analysis applies to the
second balloon being substantially aligned with and expanding a tubular
portion” (Ans. 11).
We find that Appellants have the better position. While we agree with
the Examiner that claims are read broadly, we find the Examiner’s reading
of claim 1 to be unreasonable and inconsistent with the Specification. See
In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination
proceedings, claims are given their broadest reasonable interpretation
consistent with the specification.”). Specifically, Appellants’ Specification
indicates that “the first balloon 806 may be sized and adapted to flare the
flaring portion 804 of a branch vessel prosthesis 11, as described herein, and
the second balloon 808 may be sized and to adapted expand a tubular portion
of a branch vessel prosthesis, as described herein,” and “[a]ccordingly, the
balloons may have different compliances” (Spec. ¶ 139). There is nothing
in the Specification to suggest that the balloons with different compliances
may be configured to expand both portions of the prosthesis. We therefore
interpret the limitation “wherein the first balloon is aligned substantially
with the flaring portion and the second balloon is aligned substantially with
the tubular portion such that inflation of the first balloon flares the flaring
portion and inflation of the second balloon expands the tubular portion” to
require that the two different balloons function to inflate different portions of
the stent graft, rather than permit both balloons to inflate both portions of the
stent graft.
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Therefore, while Goodin teaches two balloons that are differently
compliant (FF 6–9), the Examiner has not identified any suggestion in
Goodin to limit the inflation of the two balloons to particular locations of the
stent graft. In addition, while Vardi and Lam might be relied upon to
suggest the use of multiple balloons, the Examiner does not identify any
suggestion to inflate two balloons in a specific location to flare a stent and a
different balloon in a different location to expand the tubular portion of the
stent. Finally, the Examiner does not identify any teaching or suggestion in
either Vardi or Lam for two balloons where “the second balloon is less
compliant than the first balloon” as required by claim 1.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Vardi, Goodin, and Lam render the claims obvious.
B-C. Provisional Double Patenting Rejections
Appellants have not identified any reversible error in the Examiner’s
provisional obviousness-type double patenting rejection in question.
Appellants state that “the provisional double-patenting rejections are not
discussed further” in the Appeal Brief (App. Br. 3). Thus, we summarily
affirm the provisional rejections on the ground of nonstatutory obviousness-
type double patenting based upon the Examiner’s explanation and reasoning
(Ans. 9–11). See Manual of Patent Examining Procedure § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, appellant has waived any challenge to that ground of rejection and the
Board may summarily sustain it.”); see also In re Berger, 279 F.3d 975, 984
(Fed. Cir. 2002) (in which the Board affirmed an uncontested rejection of
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claims under 35 U.S.C. 112, second paragraph, and on appeal the Federal
Circuit affirmed the Board’s decision and found that the appellant had
waived his right to contest the indefiniteness rejection by not presenting
arguments as to error in the rejection on appeal to the Board).
SUMMARY
In summary, we reverse the rejection of claim 1–4, 6–8, 12, 14–19,
and 27–30 under 35 U.S.C. § 103(a) as obvious over Vardi, Goodin, and
Lam.
We summarily affirm the rejection of claims 1, 6–8, 12, 16–19, and
27–30 on the ground of provisional nonstatutory obviousness-type double
patenting as being unpatentable over claims 1, 3, 6, 7, 10, 13, and 15 of
copending Application No. 11/547,020 in view of Vardi.
We summarily affirm the rejection of claims 2–4, 14, and 15 on the
ground of provisional nonstatutory obviousness-type double patenting as
being unpatentable over claims 1, 3, 6, 7, 10, 13, and 15 of copending
Application No. 11/547,020 in view of Vardi and Lam.

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

cdc