Ex Parte Miller et al

Board of Patent Appeals and Interferences

Jan 23, 2012

11232682 (B.P.A.I. Jan. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MATTHEW J. MILLER and CRAIG L. KVEEN
____________

Appeal 2010-001081
Application 11/232,682
Technology Center 3700
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Before LINDA E. HORNER, WILLIAM V. SAINDON, and
MICHAEL C. ASTORINO, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Matthew J. Miller and Craig L. Kveen (Appellants) seek our review
under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1-19 and
21. Claim 20 has been canceled. We have jurisdiction under 35 U.S.C.
§ 6(b). We REVERSE.
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THE INVENTION
Appellants’ invention “is directed to a stent containing a tether guided
side branch.” Spec. 3, ll. 4-5. Claim 1, reproduced below, is the sole
independent claim and is representative of the subject matter on appeal.
1. A bifurcated stent comprising:
a substantially tubular primary body defining a
circumferential plane, an outer surface, a primary lumen and
having a primary longitudinal axis extending therethrough, the
primary body being expandable from an unexpanded state to an
expanded state, wherein in the unexpanded state the primary
body has a diameter less than that of the diameter in the
expanded state, the primary body comprising a side branch
assembly, in the expanded state the side branch assembly
comprising a substantially tubular secondary body defining a
secondary lumen having a secondary longitudinal axis
extending therethrough, the secondary lumen being in fluid
communication with the primary lumen, the secondary
longitudinal axis forming an oblique angle with the primary
longitudinal axis; and
at least one tether, the at least one tether having a first
end, a second end and a length therebetween, the first end
engaged to the primary body and a second end engaged to the
secondary body, in the unexpanded state, at least a portion of
the tether length extending along the circumferential plane of
the primary body, in the expanded state at least a portion of the
length of the tether moved to a position defining a vector which
forms an angle greater than zero with the circumferential plane
of the primary body.
THE REJECTIONS
Appellants seek review of the following rejections:
1. Claims 1-4 and 8-11 are rejected under 35 U.S.C. § 102(b) as
anticipated by Brucker (US 2002/0193873 A1; pub. Dec. 19, 2002).
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2. Claims 5-7, 18, and 19 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Brucker.
3. Claims 12-17 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Brucker and Shanley (US 6,293,967 B1; iss. Sep. 25, 2001).
4. Claim 21 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Brucker and Kugler (US 6,273,909 B1; iss. Aug. 14, 2001).
ISSUE
The Examiner determined that Brucker’s bifurcated stent delivery
system having a guide wire 72 anticipates the claimed bifurcated stent
having at least one tether. Ans. 4. Appellants argue that Brucker’s guide
wire is not a tether because it does not have “a first end engaged to the
primary body and a second end engaged to the secondary body” as called for
in claim 1. App. Br. 12. The issue presented by this appeal is whether
Brucker’s guide wire is a tether as called for in claim 1.
ANALYSIS
Appellants’ Specification describes that a “tether acts on the structural
members of the side branch assuring that the side branch opens away from
the main fluid lumen of the stent body and forms a second fluid lumen.”
Spec. 3, ll. 5-7. The Specification also describes that in one embodiment
“tether (4) spans between a first tether end (25) connected to the primary
stent body (1) [sic, (11)] and a second tether end (30) connected to the side
branch assembly (10).” Spec. 8, ll. 23-24; fig. 1. The Specification
describes:
When the primary stent body (11) expands, the struts of the
primary stent body (9) straighten or otherwise alter their
shape/configuration to accommodate expansion of the stent
body (11). This alteration impels the position of the first tether
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end (25) on the main stent body to move away from the
member (18) where the second tether end (30) is located. The
presence of the tether however, harnesses these positional
changes in position to effectively ‘pull’ upon the member (18)
out of the circumferential plane (23) of the primary stent body
(11) and to form the walls of the side branch assembly (10)
which defines the secondary fluid lumen.
Spec. 8, l. 24 - 9, l. 1; fig. 3. In each of the embodiments disclosed in the
Specification, the tether is connected at one end to the primary stent body
and at the other end to the side branch assembly so that upon expansion of
the primary stent body the tether causes the side branch assembly to open
away from the main fluid lumen of the primary stent body. One having
ordinary skill in the art would understand the phrase “engaged to” in
claim 1, when read in light of the Specification, to call for the first end of the
tether to be connected to the primary stent body and the second end of the
tether to be connected to the secondary body so that expansion of the
primary stent body causes movement of the position of the tether relative to
the primary stent body and opening of the secondary body.
Brucker discloses a bifurcated stent delivery system that uses primary
and secondary guide wires for delivering two stent bodies to a bifurcation of
vessels. Brucker 2, para. [0023]. Brucker discloses an embodiment of the
system in which “a first catheter 70 is advanced along a first guide wire 72
which extends through the primary vessel 44 and into the secondary vessel
46.” Brucker 5, para. [0072]; figs. 9, 10. The catheter 70 includes a first
stent body 74 retained on the catheter 70 in an unexpanded state. Id. In an
expanded state, first stent body 74 includes a side opening 16 that provides a
primary flow path 20 through which a second guide wire 90 may be
advanced. Brucker 5, para. [0074]. A second stent delivery catheter 92 may
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then be advanced along the second guide wire 90 to position a second stent
body 94 through the side opening 16. Brucker 5, para. [0076]; fig. 12. The
second stent body 94 is then expanded. Brucker 5, para. [0077]; fig. 13.
Brucker’s guide wire 72 is not connected to Brucker’s first stent body
74. Rather, first catheter 70 and first stent body 74 are advanced along guide
wire 72 to the bifurcation site. Thus, contrary to the Examiner’s finding
(Ans. 6), Brucker does not disclose engagement of guide wire 72 to stent
body 74. Brucker’s guide wire 72 is not the claimed tether. For this reason,
we cannot sustain the rejection of claims 1-4 and 8-11 as anticipated by
Brucker.
The remaining rejections based on Brucker alone or in combination
with Shanley or Kugler rely on the same erroneous finding regarding the
disclosure in Brucker of a tether. As such, we cannot sustain the rejections
under 35 U.S.C. § 103(a) of claims 5-7, 18, and 19 as unpatentable over
Brucker, claims 12-17 as unpatentable over Brucker and Shanley, and claim
21 as unpatentable over Brucker and Kugler.
CONCLUSION
Brucker’s guide wire is not a tether as called for in claim 1.
DECISION
The decision of the Examiner to reject claims 1-19 and 21 is
REVERSED.

REVERSED

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