Ex Parte Schaer et al

Board of Patent Appeals and Interferences

Jun 25, 2009

10805738 (B.P.A.I. Jun. 25, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte ALAN K. SCHAER and MICHAEL D. LESH
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Appeal 2009-001840
Application 10/805,738
Technology Center 3700
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Decided:1 June 25, 2009
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Before JENNIFER D. BAHR, LINDA E. HORNER, and
KEN B. BARRETT, Administrative Patent Judges.

BARRETT, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
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Application 10/805,738

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STATEMENT OF THE CASE
Alan K. Schaer and Michael D. Lesh (Appellants) seek our review
under 35 U.S.C. § 134 of the final rejection of claims 1-15. We have
jurisdiction under 35 U.S.C. § 6(b).

SUMMARY OF THE DECISION
We REVERSE.

THE INVENTION
Appellants’ claimed invention pertains to a system for positioning an
ablation catheter at a location where a pulmonary vein extends from the left
atrium of the heart. (See Spec. 1, ll. 10-11.) Claim 1, reproduced below, is
representative of the subject matter on appeal.
1. A positioning system for guiding a medical device
to a location where a pulmonary vein extends from an atrium,
comprising:
a transeptal sheath;
a guiding introducer slidable within the transeptal sheath;
a deflectable catheter having proximal and distal end
portions, wherein the medical device is disposed along the
distal end portion, and wherein the deflectable catheter is
configured to be torquable and steerable; and
a pullwire integrated within the deflectable catheter that
is adapted to deflect at least a portion of the distal end portion
such that the deflectable catheter may be advanced through the
guiding introducer wherein the guiding introducer is pre-shaped
to direct the catheter towards the pulmonary vein and the
catheter is further directed into the pulmonary vein by
manipulation of the pullwire along the proximal end portion.

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Application 10/805,738

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THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Yang US 6,097,976 Aug. 1, 2000
Vaska US 6,237,605 B1 May 29, 2001
Lesh US 5,971,983 Oct. 26, 1999
Yang US 6,332,880 B1 Dec. 25, 2001

The following Examiner’s rejections are before us for review:
1. Claims 1-7 and 10-15 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Yang ‘880 and Yang ‘976;
2. Claim 8 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Yang ‘880, Yang ‘976, and Lesh;2 and
3. Claim 9 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Yang ‘880, Yang ‘976, and Vaska.

ISSUE
The Examiner based the conclusion of obviousness on the finding that
Yang ‘880 discloses, in Figure 11, a catheter assembly including:
[A] pullwire (32) integrated within the deflectable catheter (12)
that is adapted to deflect at least a portion of the distal end (16)
portion such that the deflectable catheter (12) may be advanced
through the guiding introducer (26) wherein the guiding
introducer (26) directs the catheter (12) towards the pulmonary

2 The Examiner lists U.S. Patent No. 6,254,599 to Lesh (issued July 3, 2001)
in the Evidence Relied Upon section of the Answer, but identifies U.S.
Patent No. 5,971,983 to Lesh in the Grounds of Rejection section (Ans. 4).
Appellants appear to recognize that the rejection is based on the Lesh ‘983
reference. (See App. Br. 5-6, 13.)
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vein and the catheter (12) is further directed into the pulmonary
vein by manipulation of the proximal end portion (14).
(Ans. 3.) Appellants argue that Yang’s element 32 is a sleeve, not a pullwire
as recited in independent claim 1. (See App. Br. 12.) Therefore, an issue
present in this appeal is:
Have Appellants shown that the Examiner erred in finding that
element 32 of Yang ‘880 corresponds to Appellants’ recited pullwire?

PRINCIPLES OF LAW
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966); see
also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407 (2007) (“While the
sequence of these questions might be reordered in any particular case, the
[Graham] factors continue to define the inquiry that controls.”). The
analysis supporting an obviousness rejection “need not seek out precise
teachings directed to the specific subject matter of the challenged claim.”
KSR Int’l Co., 550 U.S. at 418. However, “there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (citations
omitted) (cited approvingly in KSR Int’l Co., 550 U.S. at 418).

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ANALYSIS
The Rejection of Claims 1-7 and 10-15 under 35 U.S.C. § 103(a) as Being
Unpatentable over Yang ‘880 and Yang ‘976
Appellants’ independent claim 1 recites:
a pullwire integrated within the deflectable catheter that is
adapted to deflect at least a portion of the distal end portion [of
the catheter] such that the deflectable catheter may be advanced
through the guiding introducer wherein … the catheter is
further directed into the pulmonary vein by manipulation of the
pullwire along the proximal end portion.
Claims 2-7 and 10-15 depend from claim 1, and thus also require a pullwire.
As indicated by the claim language, the manipulation of the pullwire along
the proximal end portion of the catheter allows one to deflect the distal end
of the catheter so as to direct the catheter into the desired location. (See
Spec. 13, ll. 10-21 (describing the operation of a pullwire); fig. 5.)
The Examiner found that Yang ‘880 discloses “a pullwire (32)” in
figure 11. (Ans. 3.) However, Appellants note that Yang ‘880 identifies
element 32 as a “sleeve,” not a pullwire. (App. Br. 12 (citing Yang ‘880,
col. 12, ll. 34-36).) Appellants also quote from Yang’s discussion of the
purpose of an elliptical sleeve embodiment, and argue that “[t]his does not
teach or suggest the use of a pullwire to deflect at least a portion of the distal
end portion of the deflectable catheter in order to direct the catheter toward
and into the pulmonary vein.” (Id.) The Examiner does not address these
arguments in the “Response to Argument” section of the Answer. (See
Ans. 5.)
Yang ‘880 explains that sleeve 32 (which is part of the support
structure 20) carries the electrodes 28, and is attached to the distal end 16 of
the catheter tube 12. (Yang ‘880, col. 7, ll. 38-39, 59-62; see fig. 11.) The
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Examiner does not adequately explain how Yang’s depiction of a sleeve in
figure 11 constitutes the disclosure of the pullwire recited in Appellants’
claim 1. We also note that the Examiner’s finding that Yang’s catheter is
directed “by manipulation of the proximal end portion (14) [of the catheter]”
(Ans. 3) is not commensurate with the language of claim 1. Claim 1 recites
that the catheter is directed “by manipulation of the pullwire along the
proximal end portion [of the catheter].” As Yang’s sleeve 32 appears to be
located only at the distal end of the catheter tube, we fail to see how that
sleeve could be manipulated along the proximal end of the catheter. The
Examiner does not direct our attention to any portion of the secondary
reference, Yang ‘976, that discloses Appellants’ recited pullwire. (Cf. Ans.
3, 5.) Because all of the rejected claims 1-7 and 10-15 require this pullwire,
the Examiner has failed to establish a prima facie case of obviousness of
those claims over Yang ‘880 and Yang ‘976.
Claims 8 and 9 depend indirectly from independent claim 1, and,
therefore, also require a pullwire. The Examiner rejected claim 8 as
unpatentable over Yang ‘880, Yang ‘976, and Lesh, and rejected claim 9 as
unpatentable over Yang ‘880, Yang ‘976, and Vaska. (Ans. 4.) The
Examiner relies on Lesh and Vaska for the disclosures of particular ablation
elements, but did not find that either of those references discloses a pullwire.
(Id. at 4, 6-8.) Accordingly, Lesh and Vaska do not cure the deficiency of
the underlying rejection of independent claim 1 based on the two Yang
references. As such, we cannot sustain the rejection of claims 8 and 9.

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CONCLUSION
We conclude that the Appellants have shown that the Examiner erred
in finding that element 32 of Yang ‘880 corresponds to Appellants’ recited
pullwire. Thus, Appellants have shown that the Examiner erred in rejecting
claims 1-7 and 10-15 as unpatentable over Yang ‘880 and Yang ‘976; in
rejecting claim 8 as unpatentable over Yang ‘880, Yang ‘976, and Lesh; and
in rejecting claim 9 as unpatentable over Yang ‘880, Yang ‘976, and Vaska.

DECISION
The decision of the Examiner to reject claims 1-15 is reversed.

REVERSED

mls

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