Ex Parte Kusleika et al

Patent Trial and Appeal Board

Feb 8, 2013

11972778 (P.T.A.B. Feb. 8, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte RICHARD S. KUSLEIKA and BROOKE REN
__________

Appeal 2012-000201
Application 11,972,778
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and FRANCISCO C.
PRATS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to embolic
protection devices. The Examiner has rejected the claims as anticipated and
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
During treatments like balloon angioplasty, “particulate debris can be
generated at the treatment site. Infarcts, strokes, and other major or minor
adverse events are caused when debris embolizes into vasculature from the
treatment site.” (Spec. 1, ¶ 3.) The Specification discloses “an embolic
Appeal 2012-000201
Application 11/972,778

2
protection device for removing emboli from a blood vessel in a patient’s
body comprising a mesh element being expandable from a collapsed
configuration to an expanded configuration” (id. at 2, ¶ 8).
Claims 1, 3-47 and 49-70 are on appeal. Claims 24 and 63 are
representative and read as follows:
24. An embolic protection device for removing emboli from a blood
vessel in a patient’s body, comprising:
a mesh element being expandable from a collapsed configuration to an
expanded configuration;
an elongate tubular element having a proximal end having a proximal
opening, a distal end having a distal opening, and a lumen between the
proximal and distal openings, the lumen having a diameter large enough to
slideably accommodate a standard guidewire; and
an elongate shaft having no lumen, the elongate shaft being attached
to the proximal end of the elongate tubular element,
the mesh element being disposed on the elongate tubular element and
the mesh element being attached to a proximal band and a distal band, the
bands being coupled to the elongate tubular element, and one of the
proximal and distal bands being fixed to the elongate tubular element and
one of the proximal and distal bands being slidable on the elongate tubular
element.

63. An embolic protection device for removing emboli from a blood
vessel in a patient’s body, comprising:
a mesh element being expandable from a collapsed configuration to an
expanded configuration;
a first elongate tubular element having a proximal end having a
proximal opening, a distal end having a distal opening, and a lumen between
the proximal and distal openings, the lumen having a diameter large enough
to slideably accommodate a standard guidewire; and
a second elongate tubular element having a proximal end having a
proximal opening, a distal end having a distal opening, and a lumen between
the proximal and distal openings, the lumen having a diameter large enough
to slideably accommodate a standard guidewire,
Appeal 2012-000201
Application 11/972,778

3
a distal region including the distal end of the second elongate tubular
element being disposed in a portion of the lumen of the first elongate tubular
element,
a first portion of the mesh element being fixed to the first elongate
tubular element and a second portion of the mesh element being fixed to the
second elongate tubular element, the mesh element being expandable from a
collapsed configuration to an expanded configuration by movement of the
first and second elongate tubular elements relative to each other.

The claims stand rejected as follows:
• Claims 24-29 under 35 U.S.C. § 103(a) in view of Clubb,1 Wasicek2
and Linder;3
• Claims 1, 3-16, 18-23, 31, 32, 34, 44-47, 49, 50, and 52-55 under 35
U.S.C. § 103(a) in view of Clubb, Wasicek, Linder and Boyle;4
• Claim 17 under 35 U.S.C. § 103(a) in view of Clubb, Wasicek,
Linder, Boyle and McGuckin;5
• Claims 30, 33, and 35-41 under 35 U.S.C. § 103(a) in view of
Clubb, Wasicek, Linder, Boyle and Berrada;6
• Claims 42 and 43 under 35 U.S.C. § 103(a) in view of Clubb,
Wasicek, Linder, Boyle and Maahs;7
• Claim 51 under 35 U.S.C. § 103(a) in view of Clubb, Wasicek,
Linder, Boyle and Hanson;8

1 Clubb et al., US 2004/0153118 A1, Aug. 5, 2004
2 Wasicek et al., US 2006/0229657, Oct. 12, 2006
3 Linder et al., US 2006/001541 A1, Jan. 19, 2006
4 Boyle et al., US 2003/0144685 A1, July 31, 2003
5 McGuckin, Jr. et al. US 2005/0004597 A1, Jan. 6, 2005
6 Berrada et al., US 2003/0176884 A1, Sept. 18, 2003
7 Maahs, US 6,743,246 B1, June 1, 2004
8 Hanson et al., US 2002/0042626 A1, Apr. 11, 2002
Appeal 2012-000201
Application 11/972,778

4
• Claims 56-59 and 61 under 35 U.S.C. § 103(a) in view of Clubb,
Wasicek and Boyle;
• Claims 60 and 62 under 35 U.S.C. § 103(a) in view of Clubb,
Wasicek, Boyle and Berrada;
• Claims 63, 64, and 66-70 under 35 U.S.C. § 102(b) in view of
Berrada; and
• Claim 65 under 35 U.S.C. § 103(a) in view of Berrada and Chin.9
I.
The Examiner has rejected claims 1, 3-47, and 49-62 as obvious based
on Clubb and Wasicek, further combined with at least one of Linder, Boyle,
Berrada, McGuckin, Maahs, and Hanson. Since the same issue is dispositive
for all of these rejections, we will consider them together.
All of the rejected claims are directed to embolic protection devices
that comprise, among other things, an elongate tubular element, with a mesh
element disposed on it, and comprising a lumen with a “diameter large
enough to slideably accommodate a standard guidewire.” (See claims 1, 24,
27, and 56.)
The Examiner finds that Clubb discloses an embolic protection device
comprising “a mesh element (20) being expandable from a collapsed
configuration to an expanded configuration; an elongate tubular (25)
element; and the mesh element being disposed on the elongate tubular
element” (Answer 7), but does not disclose that its tubular element has a
lumen to slidably accommodate a standard guidewire (id.). The Examiner

9 Chin et al., US 2002/0042628 A1, Apr. 11, 2002
Appeal 2012-000201
Application 11/972,778

5
finds that Wasicek discloses a filter device in which “a guide wire (30)
slidably passes through the lumen of an elongate tubular element (40)” (id.),
and concludes that it would have been obvious to modify Clubb’s device
“with a guide wire in the lumen of the elongate tubular member to reduce
the space necessary for a guide wire thus reducing the overall profile of the
device” (id. at 7-8).
Appellants argue that it would not have been obvious for one of skill
in the art to combine Wasicek’s co-axial guidewire with Clubb’s device
because “the methods of use taught by Clubb describe the use of the device
of Clubb with a separate guidewire or not using a guidewire at all. Thus,
there is no motivation to modify the elongate support member of the device
of Clubb to include a guidewire lumen.” (Appeal Br. 13.)
We agree with Appellants that the Examiner has not provided
adequate reason for concluding that Wasicek would have made it obvious to
modify Clubb to include a lumen with a “diameter large enough to slideably
accommodate a standard guidewire,” as claimed. The Examiner points to
element 25 of Clubb’s device as corresponding to the claimed elongate
tubular element (Answer 7). Clubb describes element 25 of its device as
“elongate support member 25” (Clubb 5, ¶ 0056). Clubb states that the
“elongate support member is structurally similar to a traditional guidewire in
some respects. However, it is not used as a means of navigating the
patient’s vascular system and, therefore, does not need to be provided with
all of the features of flexibility and steerability as does a traditional
guidewire.” (Id. at 2, ¶ 0029.) The Examiner has not pointed to evidence in
Appeal 2012-000201
Application 11/972,778

6
Clubb that would indicate that elongate support member 25 has a lumen at
all, even if it was too small to accommodate a standard guidewire.
The Examiner reasons, however, that Clubb teaches that “a catheter
containing the filter may be advanced over the guidewire to the target.…
Thus the guidewire would run side by side inside the catheter with the filter
device.” (Answer 23.) The Examiner concludes that modifying Clubb’s
device to have a coaxial arrangement a guidewire inside an elongate shaft, as
taught by Wasicek, would reduce the profile of the device and prevent
entanglement of the components (id. at 23-24). The Examiner provides the
following diagram to illustrate:

(Id. at 24.) The diagram shows two cross-sections of a catheter, one
(“Clubb”) in which a guidewire and elongate member are side-by-side and
another (“Clubb modified by Wasicek”) in which the guidewire is inside an
elongate member, which itself is inside a catheter.
The Examiner, however, has not provided an adequate basis for the
finding that Clubb actually discloses a device in which an elongate member
and a guidewire run side-by-side within a catheter. The Examiner points to
Clubb’s paragraph 29 as support for this finding (Answer 23). That
paragraph states that
Appeal 2012-000201
Application 11/972,778

7
[i]n a typical procedure …, the elongate support member and
filter are loaded into an introducing sheath or catheter and
moved … through the catheter to the treatment site. This is
done typically by advancing a first, or introduction guidewire,
through the vessel to the region of interest. A catheter is
advanced over the guidewire to the region of interest, and the
guidewire removed. Then the filter or other functional device
carried by the elongate support member is advanced down a
catheter sheath to the region of interest but within the catheter.
(Clubb 2, ¶ 0029.)
Clubb also states that “[a]lternatively, the filter is preloaded into a catheter
and … they are together advanced through the vessel to the region of interest
without using an initial guidewire” (id.). Finally, Clubb states that,
[i]n a second alternative, an introduction guidewire is advanced
to the region of interest, and the filter (contained in a catheter)
is advanced over the guidewire to the region of interest … In
this embodiment the filter is not comprised of an elongate
support member …, and the guidewire and/or filter may be
configured to preserve a spatial relationship between the
guidewire and the filter.
(Id.)
None of these embodiments describes a system that includes a guidewire
that is side-by-side with an elongate member within a catheter. The
Examiner has not pointed to any other disclosure in Clubb that supports the
finding that Clubb discloses this feature.
The Examiner’s reason for combining Clubb and Wasicek is based on
the finding that Clubb discloses a guidewire running side-by-side an
elongate member of a filter device inside a catheter. Because the
Examiner’s basis for rejecting claims 1, 3-47, and 49-62 in view of Clubb,
Wasicek and the other cited references is based on this erroneous finding, we
Appeal 2012-000201
Application 11/972,778

8
are compelled to reverse the rejections under 35 U.S.C. § 103(a) based on
Clubb and Wasicek.
II.
The Examiner has rejected claims 63, 64, and 66-70 as anticipated by
Berrada, and has rejected claim 65 as obvious in view of Berrada and Chin.
The same issue is dispositive for both rejections.
The Examiner finds that Berrada discloses an embolic device that
comprises all of the claimed elements, including “a distal region including
the distal end of the second elongate tubular element (104) being disposed in
a portion of the lumen of the first elongate tubular element (102)” (Answer
5).
Appellants argue that Berrada’s device does not comprise this
limitation because, although Berrada’s “distal shaft 104 … is disposed
within a lumen of proximal shaft 102 … the distal end of distal shaft 104 is
not disposed within the lumen of proximal shaft 102” (Appeal Br. 9).
We agree with Appellants that the Examiner has not adequately
shown that Berrada’s device has “a distal region including the distal end of
the second elongate tubular element being disposed in a portion of the lumen
of the first elongate tubular element.” Figure 4C of Berrada is shown below:

Appeal 2012-000201
Application 11/972,778

9
Figure 4C shows “an everting filter device 124 including filter body 70
secured to distal shaft 104 at distal region 108 with distal ring 64” (id. at 7,
¶ 0092). Berrada discloses that “distal shaft 104 is disposed within a lumen
128 within proximal shaft 102. Proximal shaft 102 may be seen to terminate
distally at a proximal ring 126.” (Id.) Berrada discloses that “the degree of
eversion of filter body 70 may be controlled by slidably translating distal
shaft 104 within proximal shaft 102” (id.).
As shown in Figure 4C above, the distal end of distal shaft 104 is
encircled by a distal ring 64 that secures the filter body to distal shaft 104.
Distal ring 64 thus would prevent the distal end of distal shaft 104 from
being disposed within the lumen of proximal shaft 102, even when distal
shaft 104 was translated proximally. Thus, the Examiner has not pointed to
an adequate basis to support the finding that Berrada’s device includes a
second elongate tubular element having its distal end disposed in the lumen
of a first elongate tubular element, as required by claim 63.
The Examiner’s reasoning that “a portion of the distal end of the distal
shaft 104 is in fact inside the lumen of proximal shaft 102” and that the term
“distal end” is not “limited to the very distal edge or plane of the shaft”
(Answer 22), is not persuasive. “[D]uring examination proceedings, claims
are given their broadest reasonable interpretation consistent with the
specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). Claim 63
states that the distal shaft has “distal end” as well as a “distal region
including the distal end.” In view of the claim language distinguishing
between the distal end itself and a distal region that includes the distal end,
the Examiner’s interpretation of the claim term “distal end” as encompassing
Appeal 2012-000201
Application 11/972,778

10
a portion of the distal region other than the end itself is not reasonable. We
reverse the rejection of claim 63 and dependent claims 64 and 66-70 as
anticipated by Berrada. For the same reason, we also reverse the rejection of
claim 65 as obvious in view of Berrada and Chin.
SUMMARY
We reverse all of the rejections on appeal.

REVERSED

lp