Ex Parte Marshall et al

Patent Trials and Appeals Board

Apr 28, 2014

10630547 - (D) (P.T.A.B. Apr. 28, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MARK T. MARSHALL, TERESA A. WHITMAN,
EDUARDO N. WARMAN, JEFFREY M. GILLBERG,
MATTHEW D. BONNER, and MARK L. BROWN
__________

Appeal 2012-001158
Application 10/630,547
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN and ERICA A.
FRANKLIN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON REHEARING

Appellants have requested rehearing of the decision entered
March 3, 2014 (“Decision”). The Decision affirmed rejections of claims for
obviousness. We have reconsidered our Decision and the request for
rehearing is granted. We have jurisdiction under 35 U.S.C. § 6(b).
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Application 10/630,547

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STATEMENT OF CASE
Claim 1 is representative.
1. A medical system, comprising:
an implantable cardiac pacing pulse generator;
a first lead, comprising an elongated lead body including a first
elongated insulated conductor and a first connector formed at a proximal end
thereof; the connector including a first electrical contact electrically coupled
at a first polarity to the pacing pulse generator;
a second lead, comprising an elongated lead body including a second
elongated insulated conductor and a second connector formed at a proximal
end thereof; the connector including a second electrical contact electrically
coupled at
a second polarity to the pacing pulse generator, the pacing pulse
generator comprising means for delivering pulses between the first and
second electrical contacts;
a first pacing electrode joined to the first lead body and coupled to the
first contact of the first connector via the first conductor, the first electrode
adapted for intimate contact with tissue at a first site;
a second pacing electrode joined to the second lead body and coupled
to the second contact of the second connector via the second conductor, the
second electrode adapted for location at a second site; and
a porous layer formed over the second electrode, allowing conduction
therethrough while preventing contact between the second electrode and
tissue in proximity to the second site.

Discussion
Prior to our rehearing discussion we note that the Appeal Brief, page
4, indicated that the invention was that the first electrode “is not provided
with a porous coating,” and the “second pacing electrode” “includes a
porous layer formed over the second electrode.” (id at 5.) The Examiner
found, and we agreed, however, that the claims did not preclude the first
electrode from having a porous coating (Spec. 3) which was taught by
Carson. The only additional argument in the Brief was that the cited prior
art “[n]either discloses nor suggests any benefit that might be obtained by
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delivering pacing stimulation between two electrodes of the two different
types as set forth in the present claims.” (App. Br. 6.) Because patentability
of a product depends upon its structure and not its intended use or benefit,
and because the pending claims read upon the two porous electrodes of
Carson, we found that the Examiner had established a prima facie case of
obviousness. We had no other argument from Appellants regarding
differences in the porous electrode structures which account for “intimate
contact” or the “prevention of contact” of the electrodes. While features of
an apparatus may be recited either structurally or functionally, claims
directed to an apparatus must be distinguished from the prior art in terms of
structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-1478
(Fed. Cir. 1997).
In the Request for Rehearing, Appellants clarify their position that it
is not the porous nature of the electrodes that distinguishes their invention
from the prior art. Indeed, Appellants acknowledge that their “Specification
[discloses] a first porous electrode structure could provide intimate tissue
contact. A second, different porous electrode structure could prevent tissue
contact,” which is reflected in the pending claims. (Rehearing 3.)
Appellants argue that, although in Carson, the two electrodes relied upon by
the examiner (the atrial electrodes) are both coated with a porous coating,
“[t]he porous coated electrode in Carson cannot simultaneously be ‘adapted
for intimate contact with tissue at the site’ and be provided with a porous
coating ‘preventing contact between the second electrode and tissue.’”
(Reply Br. 3.)
According to the Specification, the first electrode has a tine structure
880 “in order to maintain intimate contact . . . with tissue at an implant site.”
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(Spec. 5.) We therefore, interpret the first electrode recited in claim 1 as
requiring some structure, such as a tine structure, to adapt the electrode for
intimate contact with tissue. According to the Specification, page 7, the
second electrode includes “a porous layer separating the second electrode
from direct touching contact with tissue adjacent to an implant site.” The
Specification does not require any structure in addition to a porous layer to
provide this function. Therefore, we interpret the second electrode recited in
claim 1 as not comprising any additional structure which would permit
“direct touching” or “intimate contact”.
Carson discloses that the electrode pore size may be chosen to be
small enough to discourage tissue ingrowth (col. 4, ll. 1-3). Carson discloses
an alternative embodiment wherein gelatin wets the ePTFE, expanding
within the pores to prevent tissue adhesion (col. 9, ll. 1-9.) Thus, Carson
reasonably discloses a porous electrode that prevents tissue contact, i.e.,
satisfying the second electrode recited in claim 1.
The Examiner argued in the Answer, page 7, that
It would have been obvious to one having ordinary skill
in the art at the time of the invention to use separate leads for
the separate electrodes, as taught by Helland et al, in the bipolar
pacing system with electrode porous layer as disclosed by
Carson, in order to allow for implantation in both the cardiac
vein and the right ventricle for pacing/defibrillation therapy.

Although Appellants admit that Helland discloses that it is known to
use an uncoated electrode (App. Br. 6) and Carson discloses that it is known
to use a coated electrode (id.) in an implantable device, what is missing from
the Examiner’s analysis is why one of ordinary skill in the art would have
been motivated to use two different types of electrodes as claimed, one
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providing intimate tissue contact and the other preventing contact, in an
implantable cardiac pacing pulse generator.
Therefore, the obviousness rejection is reversed for the reasons
herein, and the requested relief is granted.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

GRANTED

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