Ex Parte Boyle et al

Patent Trial and Appeal Board

Jan 17, 2013

11327795 (P.T.A.B. Jan. 17, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CHRISTOPHER T. BOYLE, STEVEN R. BAILEY,
JULIO C. PALMAZ, and CHRISTOPHER E. BANAS
__________

Appeal 2011-005576
Application 11/327,795
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims directed to an endoluminal stent. The claims have been rejected on
the grounds of anticipation, obviousness and indefiniteness. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse the anticipation and obviousness rejections, and affirm the
indefiniteness rejection.

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STATEMENT OF THE CASE
Claims 1-11 and 14-18 are pending and on appeal. Claims 12, 13, and
19-20 are also pending, but have been withdrawn from consideration.
Claims 1 and 18 are representative:
1. An intraluminal device comprising a generally tubular member having
a plurality of struts and a plurality of interconnecting members, forming
circumferential walls thereof, each of the plurality of struts further having a
generally sinusoidal curve thereto defining peaks and valleys of each of the
plurality of struts and arranged generally sinusoidal and parallel to a
longitudinal axis of the generally tubular member, each of the plurality of
struts being in spaced-apart, in-phase relationship with respect to an adjacent
one of the plurality of struts substantially about a circumferential aspect of
the tubular member and the plurality of interconnecting members
interconnecting adjacent pairs of struts and extending between a peak of a
first strut and a valley of a second strut, wherein no more than one
interconnecting member connects to any given peak or valley.
18. An intraluminal stent comprising a generally tubular member having a
plurality of generally sinusoidal members being substantially parallel to a
longitudinal axis of the generally tubular member and extending along the
entire length of the longitudinal axis, each of the plurality of generally
sinusoidal members being in spaced-apart, in-phase relationship with respect
to an adjacent one of the plurality of generally sinusoidal members
substantially about a circumferential aspect of the tubular member; and a
plurality of interconnecting members interconnecting adjacent pairs of first
structural elements and extending between a peak of a first generally
sinusoidal member and a valley of a second, circumferentially adjacent
generally sinusoidal member, such that no more than one interconnecting
member connects to any given peak or valley of adjacent generally
sinusoidal members.
The Examiner relies on the following evidence:
Kanesaka et al. US 5,810,872 Sep. 22, 1998
Smith et al. US 6,409,754 B1 Jun. 25, 2002
Roubin at el. US 6,475,236 B1 Nov. 5, 2002
Whitcher et al. US 2003/0018381 A1 Jan 23, 2003

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The claims stand rejected as follows:
I. Claims 1-4 and 14-18 under 35 U.S.C. § 102(b), as anticipated
by Kanesaka;
II. Claims 1-4, 8, and 18 under 35 U.S.C. § 102(e) as anticipated
by Roubin.
III. Claims 5-7 and 9-11 under 35 U.S.C. § 103(a) as unpatentable
over Kanesaka or Roubin, in view of Smith.
IV. Claims 7 and 9-11 under 35 U.S.C. § 103(a) as unpatentable
over Kanesaka or Roubin, in view of Whitcher.
V. Claims 14-17 under 35 U.S.C. § 112, second paragraph, as
indefinite.
ANTICIPATION BY KANESAKA
Issue
Independent claims 1 and 18 require, in relevant part, a generally
tubular intraluminal device with a plurality of spaced apart, sinusoidal struts
defining peaks and valleys, wherein the struts are parallel to the longitudinal
axis of the device, and wherein adjacent struts are arranged in an “in-phase
relationship” with each other “substantially about a circumferential aspect”
of the device.
The Examiner finds that Kanesaka discloses a stent that meets all the
limitations of independent claims 1 and 18. In particular, the Examiner finds
that the stent depicted in Figure 8 of Kanesaka (reproduced below) has a
plurality of sinusoidal struts parallel to the longitudinal axis of the stent, with
adjacent struts in an in-phase relationship, with “peaks aligned and valleys
aligned . . . about a circumferential aspect of the tubular member” (Ans. 6).
That is, the Examiner finds that the peaks and valleys of adjacent struts on
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Kanesaka’s stent are aligned along a helical line that extends around the
circumference of Kanesaka’s stent, and “[a] helical line . . . [that] extends
around the circumference . . . may be considered a circumferential aspect as
much as a circular perpendicular line” (id. at 10).
Appellants contend that Kanesaka’s struts are not in an “in-phase
relationship with respect to an adjacent one of the plurality of struts
substantially about a circumferential aspect of the tubular member” as
required by the claims on appeal, when the claims are interpreted in light of
the Specification (App. Br. 12).
The issue raised by this rejection is whether the Examiner has
established that adjacent struts in Kanesaka’s device are arranged in an “in-
phase relationship . . . substantially about a circumferential aspect” of the
device as required by the claims on appeal, when the claims are interpreted
in light of the Specification.
Findings of Fact
1. Figure 1 of the present Specification is reproduced below:

Figure 1 of the Specification is a perspective view of a stent 10 that
meets the limitations of independent claims 1 and 18. Stent 10 “consists
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generally of a tubular cylindrical element . . . A plurality of first structural
elements 16 are arrayed about the circumferential axis C= [sic, C'] of the
stent 10 and extend parallel along the longitudinal axis of stent 10” (Spec.
10: 6-8). The “first structural elements 16 have a generally sinusoidal
configuration with a plurality of peaks 16a and a plurality of troughs 16b”
(id. at 10: 10-11), and “[a] plurality of second structural elements 18
interconnects adjacent pairs of the . . . first structural elements 16” (id. at 10:
8-9).
2. Figures 2A and 2B of the present Specification are reproduced
below:

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Figures 2A and 2B of the Specification depict compressed and
expanded fragmentary side elevational views of a stent 20 that meets the
limitations of claims 1 and 18. Stent 20 “consists of a plurality of first
structural elements 22 and a plurality of second structural elements 24 which
interconnect adjacent pairs of the . . . first structural elements 22” (Spec. 15:
27-30). The first structural elements 22 “extend[] parallel to the longitudinal
axis L= [sic, L'] of the stent 20 . . . [and] ha[ve] a sinusoidal configuration
consisting of a plurality of successive peaks 26 and troughs 28” (id. at 15: 30
- 16: 4).
The “first structural elements 22 are arrayed about the circumference
of stent 20 such that the peaks 26 and the troughs 28 of each individual first
structural element 22 are in phase with respect to adjacent peaks 26 and
troughs 28 of adjacent first structural elements 22” (id. at 16: 4-7).
3. Figure 8 of Kanesaka is reproduced below:

Figure 8 of Kanesaka depicts stent 35, “formed of a plurality of
tortuous members 36 spirally arranged in a cylindrical form” (Kanesaka, col.
5, ll. 16-17). “The tortuous member 36 includes long struts 37, and short
struts 38 . . . Connecting portions 40 connect the short and long struts 37, 38
to form the tortuous member 36. The tortuous members 36 situated adjacent
to each other are connected by joint struts 41” (id. at col. 5, ll. 17-22).
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Discussion
According to the Examiner, Kanesaka’s stent has sinusoidal struts,
made up of elements 38 and 41, which extend along the longitudinal axis of
the stent, and are interconnected by elements 37. The Examiner further
finds that the peaks and valleys of adjacent struts on Kanesaka’s stent are
aligned, i.e., are in phase, along a circumferential aspect of the stent (Ans.
6), since “[a] helical line still extends around the circumference and may be
considered a circumferential aspect as much as a circular perpendicular line”
(id. at 10).
The Specification does not explicitly define the term “in-phase . . .
about a circumferential aspect,” but it does provide numerous examples of
sinusoidal struts arranged in such a manner. In Figures 2A and 2B, and in
every other figure describing an “in phase” embodiment, the peaks and
troughs (or valleys) of adjacent sinusoidal struts are aligned along a
circumferential axis perpendicular to the longitudinal axis of the device
(FF2; see also Figures 3-5; Spec. 17: 3-6, 18: 2-5, 29-30; 19: 1-2). No
embodiment described in the Specification has the peaks and valleys of
adjacent sinusoidal struts aligned along a helical line.
We agree with Appellants that the Examiner has not established that
adjacent struts in Kanesaka’s device, which are aligned along an imaginary
line spiraling around the stent, are arranged in an “in-phase relationship . . .
about a circumferential aspect” of the device as required by the claims on
appeal, when the claims are interpreted in light of the Specification (App.
Br. 12; Reply Br. 6).
The rejection of claims 1-4 and 14-18 as anticipated by Kanesaka is
reversed.
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ANTICIAPTION BY ROUBIN
Issue
Independent claim 1 also requires, in relevant part, “interconnecting
members interconnecting adjacent pairs of struts and extending between a
peak of a first strut and a valley of a second strut.” Claim 18 has a similar
requirement.
The Examiner finds that Roubin discloses a stent that meets all the
limitations of independent claims 1 and 18. In particular, the Examiner finds
that the stent depicted in Figure 4A of Roubin (reproduced below) has a
plurality of struts “being generally sinusoidal and parallel to a longitudinal
axis of the [stent]” (Ans. 7), wherein “interconnecting members . . . extend[]
between a peak of a first strut and a valley of a second strut” (id.).
Appellants contend that the claims require “interconnecting members
interconnecting adjacent pairs of struts and extending between a peak of a
first strut and a valley of a second strut where the struts extend . . . generally
parallel to a longitudinal axis” of the stent, while Roubin’s stent, in contrast,
is “comprised of annular elements connected by longitudinal connecting
members” (App. Br. 14-15). Moreover, Appellants contend that Roubin
“does not disclose a ‘plurality of interconnecting members interconnecting
adjacent pairs of struts and extending between a peak of a first strut and a
valley of a second strut,” as required by the claims on appeal (id. at 17-18).
The issue raised by this rejection is whether the Examiner has
established that Roubin discloses a stent with longitudinal, sinusoidal struts
with “interconnecting members interconnecting adjacent pairs of struts and
extending between a peak of a first strut and a valley of a second strut” as
required by the claims on appeal.
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Findings of Fact
4. Figure 4A of Roubin is reproduced below:

Figure 4A is a side elevational view of Roubin’s stent with the
longitudinal axis of the stent extending between the left and right sides of the
figure. Roubin teaches that “[t]he stent 40 has a plurality of pairs of
alternating left struts 42 and right struts 44. Each pair of left and right struts
42, 44 is connected at an apex 46 to form a substantially V-shape for the
pair” (Roubin, col. 5, ll. 40-43). “[T]he alternating left and right struts 42
and 44 extend in an annular manner around the tubular stent 40 to form an
annular element” and “[e]ach apex 46 is connected to another apex 46 by a
connecting member 48” (id. at col. 5, ll. 50-53). “Each connecting member
48 extends longitudinally along a longitudinal extension 52 from an apex 46
. . . [and] has a plurality of alternating curved segments that are defined by
the alternating top and bottom apices 56, 60 and 64” (id. at col. 5, l. 65 - col.
6, l. 11).
5. Roubin teaches that the stent can be “fabricated from a solid
Nitinol tube . . . [by] a computer-guided laser cutter or lathe which cuts out
the segments between the struts 42, 44 and the connecting members 48”
(Roubin, col. 9, ll. 27-33).
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Discussion
Roubin’s stent can be cut from a solid Nitinol tube (FF5), thus, the
designation of any particular portion as a “strut” or a “connector” is
essentially arbitrary - with the stipulation that any given portion cannot
simultaneously be both a strut and a connector. That being the case, we
agree with the Examiner that one can trace out adjacent, sinusoidal struts
that extend along the longitudinal axis of the stent, and are connected by
interconnecting members, as shown below in the Examiner’s annotated
version of Roubin’s Figure that accompanied the Final Rejection and the
Answer (Attachment #2):

As interpreted by the Examiner, longitudinal struts with multiple
peaks and valleys are represented by heavy, dark lines, while elements 44 on
the left side of the figure are interconnecting members that connect adjacent
struts, as are elements 42 on the right side of the figure (elements 42 on the
left side are incorporated into the struts in this scenario, as are elements 44
on the right side).
Appellants have not explained why the Examiner’s designation of
these elements as struts and interconnecting members is incorrect. That
being the case, the question that remains is whether the interconnecting
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members “interconnect[] adjacent pairs of struts and extend[] between a
peak of a first strut and a valley of a second strut” as required by the claims.
On this point, we agree with Appellants that the Examiner’s
“annotations on FIG. 4A . . . indicate that the left ‘interconnecting member’
connects a ‘valley’ at a top left end thereof to another ‘valley’ at a bottom
right end thereof” (App. Br. 16), thus, “Roubin does not disclose a ‘plurality
of interconnecting members interconnecting adjacent pairs of struts and
extending between a peak of a first strut and a valley of a second strut,’” as
required by the claims.
The rejection of claims 1-4, 8, and 18 as anticipated by Roubin is
reversed.
OBVIOUSNESS
Obviousness rejections III and IV are based on the Examiner’s
underlying finding that adjacent struts in Kanesaka’s device are arranged in
an “in-phase relationship . . . about a circumferential aspect” of the device
(Ans. 6, 8). Alternatively, rejections III and IV are based on the Examiner’s
underlying finding that Roubin discloses a stent with interconnecting
members interconnecting adjacent pairs of sinusoidal struts and extending
between a peak of a first strut and a valley of a second strut (id. at 7, 8).
As we have determined that that the record does not support either of
these findings, and the Examiner has not explained how the deficiencies are
made up by Smith or Whitcher, we will reverse these rejections as well.
INDEFINITENESS
According to the Examiner, “[i]t is unclear how each strut has tapered
end regions, when the independent claim describes the struts as each
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extending the entire length of the device (not just between a peak and a
valley), and the ends of the stent are not shown as tapered” (Ans. 5).
Appellants do not challenge the propriety of this rejection. Rather,
Appellants acknowledge that “the bodies of claims 14 and 15 are transposed
and include errors that arose when amendments were made thereto” (App.
Br. 30).
The rejection of claims 14-17 as indefinite is affirmed.
SUMMARY
I. The rejection of claims 1-4 and 14-18 as anticipated by
Kanesaka is reversed.
II. The rejection of claims 1-4, 8, and 18 as anticipated by Roubin
is reversed.
III. The rejection of claims 5-7 and 9-11 as unpatentable over
Kanesaka or Roubin, in view of Smith is reversed.
IV. The rejection of claims 7 and 9-11 as unpatentable over
Kanesaka or Roubin, in view of Whitcher is reversed.
V. The rejection of claims 14-17 as indefinite is affirmed.
TIME PERIOD FOR RESPONSE
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-IN-PART

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