Ex Parte Janke et al

Board of Patent Appeals and Interferences

Sep 26, 2008

10650207 (B.P.A.I. Sep. 26, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte
AARON W. JANKE, MARY LEE COLE, RONALD W. HEIL, JR.,
JEFFREY T. BARTIG, GARY W. GOEBEL, DOUGLAS A. HEITKAMP,
and RANDALL M. PETERFESO
__________

Appeal 2008-4330
Application 10/650,207
Technology Center 3700
__________

Decided: September 26, 2008
__________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

REMAND TO THE EXAMINER
This is an appeal under 35 U.S.C. § 134 involving claims to an
electrode for implantation into the heart. The Examiner has entered a
number of obviousness rejections. We have jurisdiction under 35 U.S.C.
§ 6(b).
Appeal 2008-4330
Application 10/650,207

Because the appealed rejections are not set forth in a manner that
allows meaningful review, we remand the case to the Examiner to reconsider
them in light of the following discussion.
STATEMENT OF THE CASE
Claims 1-8 and 16-19 stand rejected and are on appeal (App. Br. 4).
Claim 1 is illustrative of the appealed subject matter and reads as follows:
1. A distal tip electrode adapted for implantation on or
about the heart and for connection to a system for monitoring or
stimulating cardiac activity, said electrode comprising:
an electrode tip;
a mesh screen disposed at a distal end of the electrode
tip;
a surface at the distal end of the electrode tip;
a helix disposed within said electrode, said helix adapted
for travel along a radial axis of the electrode through said
surface, the helix including non-soluble insulating material
coated on at least a portion of its surface to conform to the outer
surface of the helix, the insulating material including an active
ingredient;
a guiding mechanism for directing movement of the
fixation device during travel; and
a movement assembly, said movement assembly for
providing movement to said fixation device.

The Examiner cites the following documents as evidence of
unpatentability:
Grassi US 4,624,265 Nov. 25, 1986
Heil, Jr. et al. US 4,819,661 Apr. 11, 1989
Bisping US 4,886,074 Dec. 12, 1989
Dutcher et al. US 5,217,028 Jun. 8, 1993
Jammet US 5,447,534 Sep. 5, 1995
Vachon US 5,531,780 Jul. 2, 1996
Altman US 5,551,427 Sep. 3, 1996
Pohndorf et al. US 5,776,178 Jul. 7, 1998

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Application 10/650,207

Ocel et al. US 5,837,006 Nov. 17, 1998
Struble US 5,871,531 Feb. 16, 1999
Hoffmann et al. US 5,902,329 May, 11 1999

The following rejections are before us for review:
Claims 1-5, 7, 8, and 16-19 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Bisping (Ans. 3-6).
Claims 1, 2, 3, 7, 8, and 16-19 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Grassi (Ans. 6-9).
Claims 4 and 5 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Grassi (Ans. 9-10).
Claim 6 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Bisping or Grassi (Ans. 10).
OBVIOUSNESS
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992).
In rejecting claims 1-5, 7, 8, and 16-19 as obvious over Bisping, the
Examiner finds that Bisping discloses a device having all the features of
claim 1, “except for the mesh screen disposed on the electrode tip and the
helix having a non-soluble insulating conforming coating with an active
ingredient, such as an anti-inflammatant” (Ans. 3). The Examiner’s
statement of rejection does not directly cite any prior art to show that these
differences would have been obvious to a person of ordinary skill in the art.
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Application 10/650,207

Rather, the Examiner’s statement of rejection merely states that the
missing features were “known in the art” (Ans. 3-4). For example, regarding
the coating on the claimed electrode’s helix, the Examiner concludes:
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify the heart lead
as taught by Bisping, with . . . the helix having a non-soluble
insulating conforming coating with an active ingredient, such as
an anti-inflammatant . . . since it was known in the art for heart
leads to use a helix having a non-soluble insulating conforming
coating with an active ingredient, such as an anti-inflammatant,
to provide a biocompatible coating that does not
degrade/breakdown in the body, to allow the electrical
properties (impedance, current density, etc) of the helix to be
changed for more effective sensing and pacing, the conforming
coating to allow the fixation to still be inserted into the heart
with out causing increased damage, and to include an active
ingredient in the insulation to reduce irritability and
inflammation of the helix.

(Id.)
However, the Examiner points to no specific disclosure in the prior art
that supports the above assertions regarding the claimed coating’s
art-recognized advantages. Instead, after essentially asserting that a single
reference, Bisping, demonstrates the obviousness of the rejected claims, the
Examiner provides a separate listing of five references -- Dutcher, Heil,
Altman, Struble, and Pohndorf -- that are asserted to show that the
limitations in claim 1 not taught by Bisping were “notoriously well known”
elements of the type of electrode disclosed by Bisping (Ans. 4-6).
However, “[w]here a reference is relied on to support a rejection,
whether or not in a ‘minor capacity,’ there would appear to be no excuse for
not positively including the reference in the statement of the rejection.” In
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Application 10/650,207

re Hoch, 428 F.2d 1341, 1342 n.3 (CCPA 1970); see also MPEP §
706.02(j).
Thus, in the instant case, if the Examiner considers claims 1-5, 7, 8,
and 16-19 to be obvious in view of Bisping, Dutcher, Heil, Altman, Struble,
and Pohndorf, then the statement of rejection should say so, rather than
saying that the claims are obvious over Bisping by itself.
Also, the statement of rejection is self-contradictory because, on one
hand, the Examiner initially asserts, in essence, that the rejected claims
would have been obvious in view of a single reference, while on the other
hand, the Examiner later cites five references in addition to the primary
reference as evidence of obviousness. Moreover, because the statement of
rejection lists Bisping as the only specific prior art basis for the conclusion
of obviousness, it is unclear whether the Examiner is relying on all, or only a
few, of the later-cited references; it is also not clear whether those references
are intended to be applied alternatively, cumulatively, or in combination to
reach the limitations of the claims.
Every one of the appealed rejections suffers from this same
deficiency. Specifically, in rejecting claims 1, 2, 3, 7, 8, and 16-19 as
obvious over Grassi by itself, the Examiner acknowledges Grassi’s failure to
disclose an electrode having the mesh and coating recited in claim 1 (Ans.
6), but concludes that an electrode having those features would have been
obvious because the claimed elements were “known in the art” (id. at 7).
The Examiner then separately cites Dutcher, Heil, Altman, Struble,
and Pohndorf to show that the limitations in claim 1 not taught by Grassi
were “notoriously well known” elements of an electrode of the type
disclosed by Grassi (Ans. 8-9). Again, however, if the Examiner considers
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Appeal 2008-4330
Application 10/650,207

claims 1, 2, 3, 7, 8, and 16-19 to be obvious over Grassi, Dutcher, Heil,
Altman, Struble, and Pohndorf, then the statement of rejection should say so,
rather than saying that the claims are obvious over Grassi by itself.
Similarly, in rejecting claims 4 and 5 as obvious over Grassi (Ans. 9-
10), the Examiner does not cite any prior art to demonstrate the obviousness
of the asserted missing elements, a knob and slot in the electrode
mechanism, until citing the Bisping, Ocel, and Jammet references in
response to Appellants’ arguments (id. at 15). Again, if the Examiner
considers claims 4 and 5 to be obvious over Grassi, Bisping, Ocel, and
Jammet, then the statement of rejection should say so, so that the rationale
for the rejection is clear.
Similarly, in rejecting claim 6 as obvious over Bisping or Grassi (Ans.
10), the Examiner fails to cite any prior art to demonstrate the obviousness
of the asserted missing element, a groove guide in the mesh screen, until
citing the Vachon and Ocel references in response to Appellants’ arguments
(id. at 16). Again, if the Examiner considers claim 6 to be obvious over
Bisping or Grassi in view of Vachon and Ocel, then the statement of
rejection should say so, so that the rationale for the rejection is clear.
Thus, when the Examiner takes this case up for action, if the
Examiner is still of the opinion that the claims are obvious, the Examiner
should provide a statement of rejection that includes all of the prior art
references relied on, even those relied on in a minor capacity. Also, the
Examiner’s statement of rejection should clearly say where the references
disclose the asserted claim limitations, and why one of ordinary skill in the
art would have combined those specific disclosures with the disclosures in
the other references to obtain the claimed invention.
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SUMMARY
We remand for further action not inconsistent with this opinion.

REMANDED

cdc

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