Ex Parte Ospyka

Patent Trial and Appeal Board

Sep 11, 2014

10821421 (P.T.A.B. Sep. 11, 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 OSPYKA
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Appeal 2012-004145
Application 10/821,421
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 an
apparatus for inserting an electrode into a myocardium of the heart. The
Examiner rejected the claims as anticipated and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as Cardiac Pacemakers, Inc.
(see App. Br. 2).
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Application 10/821,421

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Statement of the Case
Background
“This invention relates to a heart pacemaker electrode arrangement
having an electrode that acts upon the outside of a heart and/or is arranged
with a pole in the heart tissue, and runs to an implanted heart pacemaker”
(Spec. 1 ¶ 1). The Specification teaches that the “electrode can be fixed in
the operating position by an anchor. This invention further includes a tool
that serves the positioning and fixing of the anchor” (Spec. 1 ¶ 1).
The Claims
Claims 18, 22, 33, 36, 38–40, 43, 44, and 48–50 are on appeal.2
Claim 18 is representative and reads as follows:
18. An apparatus for inserting an electrode into a myocardium of
the heart, the apparatus comprising:
an anchor configured to penetrate the myocardium in a first
orientation and to anchor against an outside surface of the heart in a
second orientation;
a tension element having a proximal end and a distal end, the
distal end fastened to the anchor; and
an electrode having an inner guide channel to accommodate the
tension element and having a pole at an end adapted for stimulating
the myocardium, the electrode and the tension element configured
such that the electrode can be threaded over the proximal end of the
tension element and slideably advanced over the tension element
towards the anchor during implantation, the guide channel having a
proximal opening adapted to allow the proximal end of the tension
element to exit therethrough;
wherein the anchor and the tension element are configured to
couple to the electrode, thereby chronically retaining the distal end of
the electrode in the heart after implantation.

2 Claims 19, 21, 24, 25, 34, 35, 37, 41, 42, and 45 stand objected to as
depending from a rejected claim (see App. Br. 2).
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The issues
A. The Examiner rejected claims 18, 22, 33, 36, 43, 44, and 50 under 35
U.S.C. § 102(a)/102(e) as anticipated by Hine3 (Ans. 4–5).
B. The Examiner rejected claims 38 and 48 under 35 U.S.C. § 103(a) as
obvious over Hine and Official Notice (Ans. 5–6).
C. The Examiner rejected claims 39, 40, and 49 under 35 U.S.C. § 103(a)
as obvious over Hine and Wesbey4 (Ans. 6).
A. 35 U.S.C. § 102(a)/102(e) over Hine
The Examiner finds that:
Hine discloses
an apparatus with an anchor 204 configured to advance to
myocardial tissue in a first orientation, and then anchor against
an epicardial surface in a second orientation (par. 0029). The
anchor may penetrate the myocardium if enough force were
applied, or if the myocardium were pre-opened. A tension
element 202 is attached to the anchor at a distal end, while an
electrode 300 with an inner guide channel is threaded over the
proximal end of the tension element and advanced towards the
anchor during implantation, where it is then attached in order to
secure the electrode in the heart (see figure 4 and par. 0030).
The electrode has a pole 308 at the distal end for stimulating the
myocardium, as well as a proximal opening that allows the
proximal end of the tension element to exit therethrough.
(Ans. 4–5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Hine teaches an “anchor
against an outside surface of the heart” as required by claims 18, 43, and 50?

3 Hine et al., US 2003/0204231 A1, published Oct. 30, 2003.
4 Wesbey, W.H., US 3,244,174, issued Apr. 5, 1966.
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Application 10/821,421

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Findings of Fact
1. Figure 3a of Hine is reproduced below:

Figure 3A shows a “stylized view of a first embodiment of a device, such as
a balloon catheter 200, which may be used to pass a lead 202 through the
cardiac venous system and then anchor a stent 204 in a desired location in a
cardiac vein” (Hine 2 ¶ 28).
2. Hine teaches that
after the catheter 200 is guided through the cardiac venous
system so that the stent 204 and the balloon 206 are at the
desired location, the balloon 206 may be momentarily inflated,
expanding the helical coil of the stent 204 into substantial
contact with the interior walls of the vein. Thereafter, the
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balloon 206 may be deflated and the catheter 200 removed. At
this point, as illustrated in FIG. 3A, the stent 204 is anchored in
the vein 300 adjacent a chamber of the heart 302 that is to be
sensed or stimulated.
(Hine 2 ¶ 29).
3. Figure 3 of the Specification is reproduced below:

Figure 3 shows “the anchor, after having been moved through the
myocardium, is located outside the myocardium in its unfolded state” (Spec.
2 ¶ 6).
Principles of Law
“[A] prima facie case of anticipation [may be] based on inherency.”
In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Once a prima facie case
of anticipation has been established, the burden shifts to the Appellants to
prove that the prior art product does not necessarily, or inherently, possess
the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255
(CCPA 1977) (“Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical or
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substantially identical processes, the PTO can require an applicant to prove
that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product.”).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 4–5; FF 1–3) and agree that the
claims are anticipated by Hine. We address Appellants’ arguments below.
Appellants contend that “[e]ach of independent claims 18, 43, and 50
require[s] an anchor configured to ‘anchor against an outside surface of the
heart.’ The stent 204 is not capable of anchoring against an epicardial
surface, but, to the contrary, is adapted to anchor with a vessel” (App. Br. 4).
The Examiner finds that the “stent of Hine could be inserted into the
myocardium, and then expanded in a way that the anchor is directly against
the outside surface of the heart” (Ans. 7).
We find that the Examiner has the better position. Hine teaches that
the “balloon 206 may be momentarily inflated, expanding the helical coil of
the stent 204 . . . At this point, as illustrated in FIG. 3A, the stent 204 is
anchored in the vein 300” (Hine 2 ¶ 29; FF 2). We agree with the Examiner
that the helical coil stent structure of the device of Hine, if expanded against
an epicardial surface after being passed through the myocardium, reasonably
would be expected to function as an anchor because the helical coil would
have been expanded to be too large to fit through the smaller opening
through which it entered.
Appellants contend that “the stent 204 of Hine is formed as a spiral or
helix. This structure is inherently incapable of anchoring ‘against an outside
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surface of the heart.’ To the contrary, this structure would simply ‘unwind’
and pass through the surface, as opposed to anchor against the surface”
(App. Br. 4–5).
We are not persuaded. While the stent 204 is a helical coil (FF 2),
Appellants provide no evidence that when anchored, this coil would unwind.
See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s
argument in a brief cannot take the place of evidence.”). The only evidence
of record also opposes Appellants’ logic, since Hine teaches that the stent
functions as an anchor in a vein (FF 1–2). If tension would result in
unwinding when the stent was anchoring against a surface, Appellants do
not provide evidence as to why the same result would not apply when the
stent was anchored in a vein. Because Hine clearly teaches that the stent can
anchor in a vein (FF 1–2), and therefore, does not unwind when anchored,
the Examiner may reasonably find that the stent of Hine will inherently
function as an anchor, in the absence of rebuttal evidence. “[W]hen the PTO
shows sound basis for believing that the products of the applicant and the
prior art are the same, the applicant has the burden of showing that they are
not.” In re Spada, 911 F.2d 705, 708 (Fed.Cir. 1990).
Appellants contend that the “skilled artisan having ‘common sense,’
would have no reason to modify or combine Hine with any other cited
reference. Thus, each of the independent claims (claims 18, 43, and 50), and
the various claims depending therefrom, stand in allowable form” (App. Br.
5).
We are not persuaded by Appellants’ argument that there is no reason
to combine because the rejection over claims 18, 43, and 50 is anticipation,
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not obviousness. Consequently, the argument regarding “reason to
combine” is not relevant to an anticipation rejection, where a “single prior
art reference that discloses, either expressly or inherently, each limitation of
a claim invalidates that claim by anticipation.” Perricone v. Medicis Pharm.
Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Hine
teaches an “anchor against an outside surface of the heart” as required by
claims 18, 43, and 50.
B–C. 35 U.S.C. § 103(a)
Appellants do not argue separately the claims in these obviousness
rejections. Having affirmed the anticipation rejection over Hine for the
reasons given above, we also find that the further obvious combinations with
Official Notice and Wesbey render the remaining claims obvious for the
reasons given by the Examiner (see Ans. 5–6).

SUMMARY
In summary, we affirm the rejection of claims 18, 43, and 50 under 35
U.S.C. § 102(a)/102(e) as anticipated by Hine. Pursuant to 37 C.F.R.
§ 41.37(c)(1), we also affirm the rejection of claims 22, 33, 36, and 44, as
these claims were not argued separately.
We affirm the rejection of claims 38 and 48 under 35 U.S.C. § 103(a)
as obvious over Hine and Official Notice, as these claims were not argued
separately.
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We affirm the rejection of claims 39, 40, and 49 under 35 U.S.C.
§ 103(a) as obvious over Hine and Wesbey, 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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