Ex Parte Jones et al

Patent Trial and Appeal Board

Nov 10, 2012

11903463 (P.T.A.B. Nov. 10, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DONALD K. JONES and VLADIMIR MITELBERG
__________

Appeal 2011-012263
Application 11/903,463
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, 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 self-
expandable aneurysm cover device. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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Application 11/903,463

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Statement of the Case
Background
“The present invention relates to a repositionable self-expanding
intravascular aneurysm cover device and a hydraulic deployment system for
placing the device at a preselected location within a vessel of the human
body” (Spec. 1, ll. 3-5).
The Claims
Claims 1-5 are on appeal. Claim 1 is representative and reads as
follows:
1. A self-expandable aneurysm cover device comprising:
a generally cylindrical skeletal frame having a
longitudinal axis, said frame including a proximal loop portion
at the proximal end of said skeletal frame which extends in a
plane between opposite sides of said generally cylindrical
skeletal frame, which is oblique to the longitudinal axis of the
skeletal frame and which has a proximal edge, an elongated
headpiece attached to the proximal edge of the proximal loop
portion and extending from said proximal edge of the proximal
loop portion in a direction generally parallel to the longitudinal
axis of the skeletal frame, said skeletal frame being adapted to
assume a normal first expanded condition to thereby cause said
loop portion to be expanded to form a loop configuration which
lies in the plane extending at an oblique angle to the
longitudinal axis of said skeletal frame and to cause said
skeletal frame to take the form of a generally cylindrical
configuration, and upon moving the elongated headpiece in a
proximal direction said proximal loop portion is caused to move
to a position such that the plane of the loop portion is closer to
parallel to the longitudinal axis of the skeletal frame thereby
causing the skeletal frame to collapse for easy withdrawal of the
aneurysm cover device from a vessel, and
wherein the cylindrical skeletal frame includes outer
struts and inner struts, the inner struts forming a connecting
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mesh extending between the outer struts, said outer struts being
larger in cross section than said inner struts, and wherein the
spacing between the inner struts in a generally central region of
said mesh is much less than the spacing of the inner struts in
portions of the skeletal frame near the outer struts.

The issue
1

The Examiner rejected claims 1-5 under 35 U.S.C. § 103(a) as
obvious over Amplatz,
2
Igaki,
3
and Whalen, II
4
(Ans. 3-9).
The Examiner finds that Amplatz teaches
a self-expandable aneurysm cover device comprising: a
generally cylindrical skeletal frame 10 . . . said skeletal
frame 10 being adapted to assume a normal first expanded
condition to thereby cause said loop portion 16 to be
expanded to form a loop configuration . . . and upon moving
the elongated headpiece 24 in a proximal direction . . .
causing the skeletal frame 10 to collapse for easy withdrawal
of the aneurysm cover device 10 from a vessel

(Ans. 3-4). The Examiner finds that the “cylindrical skeletal frame 10
includes outer struts 14, 16 and inner struts 12, the inner struts forming a
connecting mesh extending between the outer struts (Fig. 1)” (Ans. 4).
The Examiner finds that Igaki teaches “a stent 31 (Fig. 8) for a vessel
comprising a mesh wherein the spacing between the inner struts 32 (Fig. 8)

1
We note that the Examiner did not include the Walker reference
in either the statement of rejection in the Answer or the Evidence
Relied Upon section. We therefore do not further address this
reference.
2
Amplatz et al., US 6,468,301 B1, issued Oct. 22, 2002.
3
Igaki, K., US 6,413,272 B1, issued Jul. 2, 2002.
4
Whalen, II et al., US 6,569,190 B2, issued May 27, 2003.
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in a generally central region of said mesh is much less than the spacing of
the inner struts 32 in portions of the skeletal frame near the outer struts”
(Ans. 4). The Examiner finds that Igaki teaches “allowing for the inner
struts/mid portion of the stent to have a stronger weave/structure in order
maintain its expansion at the target site of the vessel to avoid collapsing of
the stent in the weakened area/target site of the vessel” (Ans. 4).
Appellants contend that the Examiner “relies on Igaki for the teaching
that the the spacing of the inner struts in a general central region of the mesh
is much less than the spacing of the inner struts in portions of the skeletal
frame near the outer struts” (App. Br. 7). Appellants contend that “Igaki is
actually teaching the exact opposite. That is, Igaki is teaching that the [] mid
portion 34 of the stent [is] capable of greater expansion to hold the stent in
the expanded portion and the end portions 35, 36 have a lower tenacity to
match that of the blood vessel that the stent is inserted in” (App. Br. 7).
Appellants contend that the “the logic behind the Examiner’s proposed
combination is in error, as Igaki actually teaches away from the combination
that the Examiner is suggesting” (App. Br. 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Amplatz, Whalen II, and Igaki
render claim 1 obvious?
Findings of Fact
1. Amplatz teaches “a low profile stent suitable for use as a
synthetic graft for the non-surgical treatment of an aneurysm” (Amplatz, col.
1, ll. 10-12).

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2. Figure 1 of Amplatz is reproduced below:

“FIG. 1 is a perspective view of a retrievable self-expanding vascular stent
graft” (Amplatz, col. 3, ll. 20-21).
3. Amplatz teaches that the
medical device can be stretched into its collapsed
configuration and inserted into the lumen of the catheter.
The collapsed configuration of the device may be of any
shape suitable for easy passage through the lumen of a
catheter and proper deployment out the distal end of the
catheter. For example, the device may have a relatively
elongated collapsed configuration wherein the device is
stretched along its longitudinal axis. This collapsed
configuration can be achieved simply by stretching the
device generally along its axis, e.g. by manually grasping
the clamps and pulling them apart, which will tend to
collapse the relaxed generally cylindrical portion of the
device inwardly toward the device’s axis. Loading such a
device into a catheter may be done at the time of
implantation and does not require pre-loading of the
introducer or catheter.

(Amplatz, col. 8, ll. 22-36).
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4. Figure 8 of Igaki is reproduced below:

“FIG. 8 is a perspective view showing a stent for a vessel of the present
invention in which the tubular member is formed by weaving a fine metal
wire or a polymer yarn” (Igaki, col. 3, ll. 15-17).
5. Igaki teaches that:
The tubular member 33 has a main mid portion 34 having
tenacity sufficient to hold the blood vessel in an expanded
state on insertion into the blood vessel. On both ends of the
main mid portion 34 are integrally formed low tenacity
portions 35, 36 lower in tenacity than the main mid portion
34. These low tenacity portions 35, 36 are formed by using a
rougher pitch of the meshes than in the main mid portion 34
having a preset mesh density. At this time, the low tenacity
portions 35, 36 are preferably knitted so as to be
progressively lower in mesh density from the main mid
portion 34 towards the ends of the tubular member 33.

(Igaki, col. 5, ll. 45-55).
6. Igaki teaches that:
It is noted that the main mid portion 34 is knitted so as to
have meshes of such density sufficient to realize the
Young’s modulus sufficiently larger than that of the blood
vessel to hold the blood vessel in an expanded state on
insertion of the stent 31 in the blood vessel, while the low
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tenacity portions 35, 36 are knitted so as to have meshes of
such density approximately equal to or slightly larger than
that of the blood vessel.

(Igaki, col. 5, ll. 56-63).
7. Whalen II, teaches a stent which “has two rigid end segments
(303, 305) which can be expanded against the sides of the parent artery in a
known manner, e.g., balloon or self expanding . . . The mechanical stent also
has a flexible region (307) or open mesh or other open structure located in
between the two rigid end segments (303, 305)” (Whalen II, col. 15, ll. 35-
40).
8. Whalen II teaches that the “flexible region (307) of the
mechanical stent allows for increased ease of manipulation or trackability of
the stent through the vasculature as the stent is directed to the site of the
aneurysm” (Whalen II, col. 15, ll. 41-43).
9. Figure 3 of Whalen II is reproduced below:

“FIG. 3 is a schematic side view of a stent for use in a method of treating an
aneurysm” (Whalen II, col. 4, ll. 48-49).
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Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
The Examiner acknowledges that the reasoning relied upon in the
Final Rejection “was a misinterpretation of Igaki’s reasoning to create a
stent structure having less spacing between the inner struts than the outer
struts” (Ans. 9).
To remedy this misinterpretation, the Examiner alters the motivation
to modify Amplatz “in order to allow for the inner struts/mid portion of the
stent to have a stronger weave/ structure in order maintain its expansion at
the target site of the vessel to avoid collapsing of the stent in the weakened
area/target site of the vessel” (Ans. 9).
We are not persuaded. While Igaki may teach a midportion 34 which
holds the blood vessel in the expanded state (FF 4-6), neither Amplatz nor
Whalen II recognize a need or reason for a strengthened stent mid portion.
Indeed, Whalen II expressly teaches that the midportion may be flexible (FF
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7-8) and uses a more open and less rigid mesh weave in the midportion of
the stent, the precise opposite of Igaki.
We do not find it reasonable to rely on Whalen II for the use of rigid
outer struts to anchor the stent and flexible inner struts in combination with
Igaki for the use of a more rigid inner struts to anchor the stent, in order to
address a claim which requires “the spacing between the inner struts in a
generally central region of said mesh is much less than the spacing of the
inner struts in portions of the skeletal frame near the outer struts” (Claim 1).
Selection of either reference alone results in a stent inconsistent with the
requirements of claim 1. However, even when combined, there is no
articulated and rational reason to select the outer strut structure from Whalen
II and the inner strut structure from Igaki other than hindsight reconstruction
of claim 1.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Amplatz, Whalen II, and Igaki render claim 1 obvious.
SUMMARY
In summary, we reverse the rejection of claims 1-5 under 35 U.S.C. §
103(a) as obvious over Amplatz, Igaki, and Whalen, II.

REVERSED
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