Ex Parte Osypka

Patent Trial and Appeal Board

May 29, 2014

11457676 (P.T.A.B. May. 29, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte PETER OSYPKA
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Appeal 2012-001195
Application 11/457,676
Technology Center 3700
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Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for inserting an electrode within a myocardium of a heart. The Examiner
rejected the claims on the ground of nonstatutory obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as Cardiac
Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
(see App. Br. 2).
Appeal 2012-001195
Application 11/457,676

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Statement of the Case
Background
“[T]he present invention is a method for inserting an electrode within
a myocardium of a heart. An anchor coupled to a tension element is inserted
through the myocardium to an operating position adjacent an exterior
surface of the myocardium” (Spec. 2 ¶ 005). “The tension element is affixed
to the electrode at a connection point to prevent movement of the electrode
in a direction away from the anchor” (Spec. 2 ¶ 005).
The Claims
Claims 1-20 are on appeal. Claim 1 is representative and reads as
follows:
1. A method for inserting an electrode within a
myocardium of a heart, the method comprising:
inserting an anchor coupled to a tension element
through the myocardium to an operating position adjacent an
outer surface of the heart;
threading an electrode having an inner guide channel
for accommodating the tension element and a pole for
stimulating the heart over an end of the tension element;
advancing the electrode over the tension element
towards the inserted anchor until the pole contacts the heart;
and
affixing the tension element to the electrode at a
connection point to prevent movement of the electrode in a
direction away from the anchor.

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Application 11/457,676

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The issue
The Examiner rejected claims 1-20 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 10-18
of Shiroff2 (Ans. 4).
The Examiner finds that “[a]lthough the conflicting claims are not
identical, they are not patentably distinct from each other because the claims
of the patent anticipate the current claims since they contain all of the
limitations of the current claims” (Ans. 4).
The issue with respect to this rejection is:
Does the evidence of record support the Examiner’s conclusion that
claims 10-18 of Shiroff render claim 1 obvious for obviousness-type double
patenting?
Findings of Fact
1. Claim 10 of Shiroff is reproduced below:
10. A method of implanting a myocardial lead attachment
system, the method comprising:
delivering an anchor mechanism coupled to a distal end of a
tether to an epicardial surface;
threading a lead body having a proximal end, a distal end, a
lumen extending through the lead body, and a fixation mechanism
positioned at the distal end over a proximal end of the tether;
advancing the lead body and fixation mechanism over the tether
toward the anchor and through the myocardium while the fixation
mechanism is in a first collapsed configuration;
deploying the fixation mechanism to a second configuration on
the epicardial surface of the heart to retain the lead body at a chosen
location; and
coupling the lead body to the anchor mechanism and the tether.

2 Shiroff et al., US 7,418,298 B2, issued Aug. 26, 2008.
Appeal 2012-001195
Application 11/457,676

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Principles of Law
“Obviousness-type double patenting is a judicially created doctrine
intended to prevent improper timewise extension of the patent right by
prohibiting the issuance of claims in a second patent which are not
‘patentably distinct’ from the claims of a first patent.” In re Braat, 937 F.2d
589, 592 (Fed. Cir. 1991) (citation omitted). “It is the claims, not the
specification, that define an invention . . . . And it is the claims that are
compared when assessing double patenting.” Ortho Pharmaceutical Corp.
v. Smith, 959 F.2d 936, 943 (Fed. Cir. 1992) (internal citation omitted).
Analysis
Appellant contends that “while claim 10 of the ‘298 patent does
specify ‘delivering an anchor mechanism coupled to a distal end of a tether
to an epicardial surface,’ the claim does not recite inserting the anchor
mechanism through the myocardium, nor does it specify inserting the
anchor to an operating position adjacent an outer surface of the heart”
(App. Br. 4).
The Examiner finds that “claim 10 recites that the tether is coupled to
the distal end of a tether as it is delivered to the epicardial surface, which is
the outer surface of the heart. Furthermore, claim 10 recites that the lead
body and fixation mechanism are advanced over the tether toward the anchor
through the myocardium” (Ans. 4-5). The Examiner finds that “[c]learly,
if the tether was attached to the anchor prior to insertion, and the tether
extends through the myocardium, the anchor also would necessarily, or at
least obviously, have had to been inserted through the myocardium to reach
the epicardial surface” (Ans. 5). The Examiner finds that “[f]urthermore, the
anchor is considered to be in an ‘operating position’ since ‘operations’ are
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Application 11/457,676

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done with the anchor after it has been placed against the epicardial surface,
as stated in claim 10 of the patent. The epicardium is the outer surface of the
heart” (Ans. 5).
We find that the Examiner has the better position. Claim 10 of Shiroff
teaches “delivering an anchor mechanism coupled to a distal end of a tether
to an epicardial surface.” This limitation clearly requires that the anchor is
implanted, with a tether attached, in a manner which results in a final
position anchor at an outer surface (“epicardial surface”) of the heart,
thereby satisfying the instant claim 1 requirement of placing the anchor in
“an operating position adjacent an outer surface of the heart.”
We also agree with the Examiner’s more subtle point, that when
Claim 10 of Shiroff teaches “advancing the lead body and fixation
mechanism over the tether toward the anchor and through the myocardium”,
the tether itself, and consequently the anchor coupled to the tether, must
necessarily have also been implanted through the myocardium, or else there
would be no path “through the myocardium” over which the lead body and
fixation mechanism could advance to the anchor. Thus, claim 10 of Shiroff
necessarily teaches the instant claim 1 requirement for “inserting an anchor
coupled to a tension element through the myocardium.”
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
claims 10-18 of Shiroff render claim 1 obvious for obviousness-type double
patenting.

Appeal 2012-001195
Application 11/457,676

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SUMMARY
In summary, we affirm the rejection of claim 1 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 10-18 of Shiroff. Pursuant to 37 C.F.R. § 41.37(c)(l)(vii), we also
affirm the rejection of claims 2-20 as these claims were not argued
separately.

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
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