Ex Parte Janke et al

Board of Patent Appeals and Interferences

Nov 5, 2010

10650207 (B.P.A.I. Nov. 5, 2010)

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 2010-002399
Application 10/650,207
Technology Center 3700
__________

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

PRATS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims to an electrode
implantable in the heart. The Examiner entered six rejections for
obviousness.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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We have jurisdiction under 35 U.S.C. § 6(b). We reverse two of the
rejections, but affirm the other four.

STATEMENT OF THE CASE
Claims 1-8 and 16-19 stand rejected and appealed (App. Br. 4).2
Claims 1 and 16, the independent claims, are representative and read 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.

16. 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; and

2 Appeal Brief entered April 27, 2009.
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a fixation helix disposed within said electrode, said
fixation helix adapted for travel along a radial axis of the
electrode through said surface, the fixation helix including a
non-soluble insulating material coated on at least a portion of
its outer surface so as to conform to the outer surface of the
helix, the insulating material including an active ingredient.

The Examiner cites the following documents as evidence of
unpatentability:
Rockland et al. US 4,010,758 Mar. 8, 1977
Grassi US 4,624,265 Nov. 25, 1986
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
Ocel et al. US 5,837,006 Nov. 17, 1998
Hoffmann et al. US 5,902,329 May 11, 1999

The following rejections are before us for review:
(1) Claims 1-5, 7, 8, and 16-19, rejected under 35 U.S.C. § 103(a) as
obvious over Bisping and Dutcher (Ans. 4-6);3
(2) Claims 1-5, 7, 8, and 16-19, rejected under 35 U.S.C. § 103(a) as
obvious over Bisping and Rockland in view of Altman or Hoffman (Ans. 7-
9);
(3) Claims 1-3, 7, 8, and 16-19, rejected under 35 U.S.C. § 103(a) as
obvious over Grassi and Dutcher (Ans. 10-12);
(4) Claims 1-3, 7, 8, and 16-19, rejected under 35 U.S.C. § 103(a) as
obvious over Grassi and Rockland in view of Altman or Hoffman (Ans. 13-
15);

3 Examiner’s Answer entered August 6, 2009.
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(5) Claims 4 and 5, rejected under 35 U.S.C. § 103(a) as obvious over
“modified Grassi rejected above” in view of Bisping, Jammet, or Ocel (Ans.
16); and
(6) Claim 6, rejected under 35 U.S.C. § 103(a) as obvious over “either
modified Bisping or either modified Grassi as applied to claim 1 above” in
view of Ocel or Vachon (Ans. 16).
OBVIOUSNESS -- BISPING AND DUTCHER
ISSUE
In rejecting claims 1-5, 7, 8, and 16-19 as obvious over Bisping and
Dutcher, the Examiner concluded that an ordinary artisan would have
considered it obvious to incorporate the drug-containing coating and mesh of
Dutcher’s heart-implantable electrode into Bisping’s heart-implantable
electrode (Ans. 4-5).
Appellants contend that Dutcher does not disclose a drug-containing
insulating material that is coated onto the helical element of its electrode, but
instead discloses a drug-containing plug around which the helical element is
wrapped (App. Br. 11-12). In particular, Appellants argue, “the plug 138 is
merely held within the rear inner area of the helix. The plug 138 itself does
not conform to or coat the helix outer surface” (Reply Br. 2).4
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether a preponderance of the
evidence of record supports the Examiner’s determination that an ordinary
artisan would have been prompted by Dutcher to include a coating having
the features recited in claims 1 and 16 on Bisping’s device.

4 Reply Brief entered October 6, 2009.
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FINDINGS OF FACT (“FF”)
1. Bisping discloses an “implantable electrode type lead assembly of the
flexible type which is particularly adapted for implantation in the cardiac
muscle for applications such as use with a pacemaker. The lead assembly
has an electrode head which includes a fixation spiral for implantation into
tissue” (Bisping, abstract; see also Figures 1 and 4).
2. Dutcher discloses a “bi-polar cardiac lead for transmitting electric
current to the heart” (Dutcher, abstract).
3. Figure 5 of Dutcher, reproduced below, is a side view of Dutcher’s
cardiac lead:

Figure 5 shows helical electrode 125, which is “a rigid helical wire
131 terminating in a pointed or sharpened end 132. A sheath 133 of non-
electrical conductive material, such as medical grade silicone rubber, covers
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the helical wire 131 except for about the end one half turn portion 134
thereof” (id. at col. 3, ll. 56-60).
4. Figure 5 of Dutcher also shows:
[T]he mid-section of the inner side of head 124 has a cylindrical
recess or pocket 137 accommodating a plug 138 impregnated
with a drug to elution [sic] at the stimulation site. . . . The inner
end section 126 of wire 131 is turned around the outer
circumference of plug 138 to locate plug 138 in co-axial
alignment with helical electrode 125. The drug will be
dispensed from the outer surface of plug 138 to the heart tissue
as plug 138 positioned in contacting relationship with the heart
tissue.

(Id. at col. 4, ll. 46-56.)
PRINCIPLES OF LAW
“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 KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, but also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
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ANALYSIS
We agree with Appellants that the teachings of Bisping and Dutcher
do not support the Examiner’s prima facie case.
Claim 1 recites an electrode for implantation on or about the heart, the
electrode having a “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.” Claim 16 similarly
requires the active ingredient-containing insulating material to be “coated on
at least a portion of [the helix’s] outer surface so as to conform to the outer
surface of the helix.”
As seen in Figure 5 of Dutcher, while the helical wire element of
Dutcher’s electrode has an insulating coating or sheath 133 (FF 3), the active
ingredient-containing portion of the electrode is drug plug 138 (FF 4).
Rather than being coated with the drug, however, the wire constituting
Dutcher’s helix is wrapped around drug plug 138 (Dutcher, col. 4, ll. 50-53
(“[t]he inner end section 126 of wire 131 is turned around the outer
circumference of plug 138”)).
Given these teachings, we are not persuaded that an ordinary artisan
would have viewed Dutcher as teaching or suggesting the drug plug coated
on the helix in the manner recited in claims 1 and 16, nor are we persuaded
that the drug plug conforms to the outer layer of the helix, since wrapping
the wire around the plug results in the plug only being on the inner part of
the helix.
The Examiner argues, alternatively, that when Dutcher’s device is
deployed, the active ingredient in the plug will migrate along the insulated
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coating, the result being that Dutcher’s device at that point has an insulating
coating on the helix that includes an active ingredient (Ans. 17).
The Examiner points to no teaching in Dutcher, however, suggesting
that the drug moves in this way. To the contrary, Dutcher discloses that the
“drug will be dispensed from the outer surface of plug 138 to the heart tissue
as plug 138 [is] positioned in contacting relationship with the heart tissue”
(Dutcher, col. 4, ll. 53-56).
In sum, we agree with Appellants that the Examiner has not
adequately explained why an ordinary artisan viewing the teachings in the
cited references would have been prompted to prepare an electrode having
the coated helix recited in claims 1 and 16. Accordingly, we reverse the
Examiner’s rejection of those claims, as well as their dependent claims 2-5,
7, 8, and 17-19, as obvious over Bisping and Dutcher.
OBVIOUSNESS --
BISPING, ROCKLAND, ALTMAN, AND HOFFMAN
ISSUE
Claims 1-5, 7, 8, and 16-19 stand rejected under 35 U.S.C. § 103(a) as
obvious over Bisping and Rockland in view of Altman or Hoffman (Ans. 7-
9). Based on the references’ teachings, the Examiner concludes that an
ordinary artisan would have considered it obvious to incorporate the mesh
from Rockland’s heart-implantable electrode, and the drug-containing
coating used in either Altman’s or Hoffman’s heart-implantable devices, into
Bisping’s device (id. at 7-8).
Appellants contend that an ordinary artisan would not have applied
Altman’s teachings to Bisping because, rather than stimulating the heart
muscle like Bisping’s electrode, Altman’s device was intended to inhibit the
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heart muscle activity at arrhythmogenic sites (App. Br. 12-13). Appellants
further argue that Hoffman teaches away from applying its hydrogel
composition as an insulating coating (id. at 13).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports the Examiner’s position that an ordinary artisan would have been
prompted by either Altman or Hoffman to include a coating having the
features recited in claims 1 and 16 on Bisping’s device.
FINDINGS OF FACT
5. Altman discloses “implantable devices for the effective elimination of
an arrhythmogenic site from the myocardium” (Altman, abstract).
6. Specifically, Altman discloses that “[b]y inserting small
biocompatible conductors, insulators, and/or combinations thereof into the
heart tissue at the arrhythmogenic site, it is possible to effectively eliminate
the arrhythmogenic effects of a portion of the tissue from the electric field
and current paths within the heart” (id. at col. 9, ll. 39-44).
7. Altman’s devices include a corkscrew-shaped helix that is inserted
into the heart tissue, the helix being “constructed with a rigid core material
58 coated or covered with an insulative controlled release matrix 60. Matrix
60 is a drug diffusion polymer system for the sustained release of drugs” (id.
at col. 10, ll. 27-30).
8. Altman discloses that its devices can deliver a number of different
types of drugs, including “anti arrhythmic agents, anti thrombogenic agents,
angiogenic factors, and/or steroidal anti inflammatory agents over an
extended period of time directly to endocardial regions” (id. at col. 6, ll. 64-
67).
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9. Altman notes that steroidal anti-inflammatory agents had been
previously incorporated into cardiac stimulation leads “to limit tissue
response to the implanted lead, and to maintain the viability of the cells in
the region immediately surrounding the implanted device” (id. at col. 6, ll. 6-
9).
ANALYSIS
We are not persuaded that the evidence fails to support the
Examiner’s obviousness determination. The Examiner contends that an
ordinary artisan would have been prompted to use either Altman’s or
Hoffman’s coating on Bisping’s device “to allow the fixation to still be
inserted into the heart with out [sic] causing increased damage, and to
include an active ingredient in the insulation to reduce irritability and
inflammation due to the helix” (Ans. 8).
Appellants do not directly address the Examiner’s position regarding
the desirability of administering anti-inflammatory agents to heart tissue via
affixed helical devices, but instead argue that “there appears to be no
motivation or reason to apply any of Altman’s or Hoffman’s discussions to
the lead of Bisping, since they are used for generally different purposes”
(App. Br. 13).
In particular, Appellants note, “Bisping gives no indication of a need
for any of the Objects of Invention described in Altman at col. 6, line 20 -
col. 7 line 3, where the Altman disclosure discusses different purposes of the
device to treat arrythmogenic sites” (id.). Thus, Appellants argue, “[m]erely
because Altman discusses a helix shape for the arrythmogenic treatment
device does not mean that his disclosure applies to a helix used for a
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completely different purpose, such as the Bisping helix, which is used as a
fixation device to hold an electrode in place” (id.; see also Reply Br. 3-4).
The Examiner has the better position, in our view.
We acknowledge Altman’s disclosure that its devices are used to
decrease or eliminate cardiac activity at problematic sites in the heart muscle
(FF 5-6). We also acknowledge that, in contrast, Bisping’s helix-containing
electrode is explicitly described as being part of a pacemaker, that is, a heart
stimulating device (FF 1).
However, as the Examiner points out, Altman discloses that its drug-
containing coating allows its device to administer anti-inflammatory drugs
directly to the heart (FF 8). Altman further discloses that anti-inflammatory
drugs are not only useful on its own anti-arrhythmogenic devices, but also
on heart-stimulating cardiac leads, to limit undesirable tissue response to the
implants (FF 9).
Thus, we agree with the Examiner that an ordinary artisan, advised by
Altman that it was desirable for heart-stimulating implants to include
anti-inflammatory agents, and also advised by Altman that its drug-
containing coating imparts anti-inflammatory properties to helical heart-
affixing devices, would have been prompted to coat at least a portion of
Bisping’s heart-affixing helix with Altman’s coating. Thus, because an
ordinary artisan would have recognized that an anti-inflammatory coating
would have been useful in heart-stimulating devices such as Bisping’s, as
well as anti-arrhythmogenic devices, Appellants’ arguments do not persuade
us that the Examiner failed to make a prima facie case of obviousness.
Accordingly, we affirm the Examiner’s rejection of claims 1-5, 7, 8,
and 16-19 as obvious over Bisping, Rockland, and Altman.
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OBVIOUSNESS -- GRASSI AND DUTCHER
Claims 1-3, 7, 8, and 16-19 stand rejected as obvious over Grassi and
Dutcher (Ans. 10-12). This rejection is similar to the rejection over Bisping
and Dutcher, except that the Examiner cites Grassi instead of Bisping as
teaching a helical/corkscrew device for affixing the electrode into the
cardiac muscle (id. at 10). As with the previous rejection, the Examiner
cites Dutcher as teaching the insulating active ingredient-containing coating
recited in claims 1 and 16.
For the reasons discussed above, we are not persuaded that Dutcher
teaches or suggests an active ingredient-containing coating with the features
required in claims 1 and 16. Accordingly, we reverse the Examiner’s
obviousness rejection of those claims, and their dependent claims 2, 3, 7, 8,
and 17-19, over Grassi and Dutcher.
OBVIOUSNESS --
GRASSI, ROCKLAND, ALTMAN, AND HOFFMAN
Claims 1-3, 7, 8, and 16-19 stand rejected as obvious over Grassi and
Rockland in view of Altman or Hoffman (Ans. 13-15).
This rejection is similar to the earlier rejection over Bisping and
Rockland in view of Altman or Hoffman, except that the Examiner cites
Grassi instead of Bisping as teaching a helical/corkscrew device for affixing
the electrode into the cardiac muscle (id. at 13). As with the earlier
rejection, the Examiner cites Rockland to show the obviousness of using
mesh on heart-affixing electrodes, and either Altman or Hoffman to show
the obviousness of an insulating active ingredient-containing coating on such
devices (id. at 13-14).
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Similar to the earlier rejection, Appellants’ argument is that an
ordinary artisan would not have applied Altman’s teachings to Grassi’s
device because the two references’ devices are used for different purposes
(App. Br. 15; see also Reply Br. 4-5). However, as discussed above, given
that an ordinary artisan would have understood from Altman that
anti-inflammatory coatings were useful on heart-stimulating implantable
devices, we are not persuaded that the artisan would have lacked impetus for
applying Altman’s coating to Grassi’s device.
Accordingly, we affirm the Examiner’s rejection of claims 1-3, 7, 8,
and 16-19 as obvious over Grassi and Rockland in view of Altman.
OBVIOUSNESS --
GRASSI, BISPING, JAMMET, AND OCEL
Claims 4 and 5 stand rejected as obvious over “either modified Grassi
rejected above” in view of Bisping, Jammet, or Ocel (Ans. 16). Claims 4
and 5 read as follows:
4. The distal tip electrode as recited in claim [1, wherein said
movement assembly comprises a piston and a base, and] wherein the
piston has a slot therein, and the base further comprises a knob, said
slot for mating with said knob.

5. The distal tip electrode as recited in claim 4, wherein the slot is
mated with said knob to form a stop mechanism for said fixation
device.

The Examiner finds that “[m]odified Grassi discloses the claimed
invention except for the knob and slot mating with the knob to form a stop
mechanism” and cites Bisping, Jammet, or Ocel to meet that feature (id.).
Based on the references’ teachings, the Examiner concludes that an ordinary
artisan would have considered it obvious
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to modify the heart lead as taught by the modified Grassi, with
a knob and slot mating with the knob to form a stop mechanism
as taught by Bisping, Jammet, or Ocel since it was known in the
art that heart leads use a knob and slot mating with the knob to
form a stop mechanism to provide the predictable results of
preventing the helix from being retracted further into the lead
and causing damage to the lead.

(Ans. 16.)
Appellants argue that claims 4 and 5 are unobvious for the reasons
advanced with respect to claim 1 (App. Br. 16). Moreover, Appellants
argue, the Examiner “has provided insufficient motivation to modify the
cited reference. Appellant notes that the mere fact that a reference can be
modified does not render the resultant combination obvious unless the prior
art also suggests the desirability of the combination” (id. (citing In re Mills,
916 F.2d 680 (Fed. Cir. 1990); MPEP § 2143.01)).
Appellants’ arguments do not persuade us that the Examiner failed to
make a prima facie case of obviousness. As discussed above, we are not
persuaded that the Examiner’s prima facie case was lacking with respect to
claim 1.
As to the motivation issue, the Examiner has provided evidence,
undisputed by Appellants, that stop mechanisms encompassed by claims 4
and 5 were known to be useful in heart-affixing electrodes like Grassi’s
(Ans. 16). In contrast, Appellants point to no evidence controverting the
Examiner’s further finding that an ordinary artisan would have considered
such mechanisms useful in Grassi’s device.
As the preponderance of the evidence supports the Examiner’s
position, we affirm the Examiner’s obviousness rejection of claims 4 and 5.
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OBVIOUSNESS --
GRASSI, BISPING, VACHON, AND OCEL
Claim 6 stands rejected as obvious over “either modified Bisping or
either modified Grassi as applied to claim 1 above” in view of Ocel or
Vachon (Ans. 16).
Claim 6 recites “[t]he distal tip electrode as recited in claim 1,
wherein the guiding mechanism includes a groove guide disposed within the
mesh screen.”
The Examiner finds that “modified Bisping or Grassi discloses the
claimed invention with a traveling helix through a mesh screen except for
the groove guide” and cites Ocel or Vachon to meet that feature (id.). Based
on the prior art teachings, the Examiner concludes that an ordinary artisan
would have considered it obvious
to modify the mesh and helical lead as taught by the modified
Bisping or Grassi, with a groove guide as taught by Ocel or
Vachon since it was known in the art that leads with traveling
helixes use a groove guide to provide the predictable results of
guiding the helix through the distal end of the lead body/mesh
to smoothly guide the helix to exit and enter the lead body.

(Id.)
Appellants argue that claim 6 is unobvious for the reasons advanced
with respect to claim 1 (App. Br. 16). Moreover, Appellants argue, the
Examiner “has provided insufficient motivation to modify the cited
reference. Appellant notes that the mere fact that a reference can be modified
does not render the resultant combination obvious unless the prior art also
suggests the desirability of the combination” (id. (citing In re Mills, 916 F.2d
680; MPEP § 2143.01)).
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Appellants’ arguments do not persuade us that the Examiner failed to
make a prima facie case of obviousness. As discussed above, we are not
persuaded that the Examiner’s prima facie case was lacking with respect to
claim 1.
As to the motivation issue, the Examiner has provided evidence,
undisputed by Appellants, that groove guides encompassed by claim 6 were
known to be useful in heart-affixing electrodes like those of Grassi and
Bisping (Ans. 16). In contrast, Appellants point to no evidence
controverting the Examiner’s further finding that an ordinary artisan would
have considered such mechanisms useful in Grassi’s or Bisping’s devices.
As the preponderance of the evidence supports the Examiner’s
position, we affirm the Examiner’s obviousness rejection of claim 6.
SUMMARY
We reverse the Examiner’s rejection of claims 1-5, 7, 8, and 16-19
under 35 U.S.C. § 103(a) as obvious over Bisping and Dutcher.
However, we affirm the Examiner’s rejection of claims 1-5, 7, 8, and
16-19 under 35 U.S.C. § 103(a) as obvious over Bisping, Rockland and
Altman.
We also reverse the Examiner’s rejection of claims 1, 2, 3, 7, 8, and
16-19 under 35 U.S.C. § 103(a) as obvious Grassi and Dutcher.
However, we affirm the Examiner’s rejection of claims 1, 2, 3, 7, 8,
and 16-19 under 35 U.S.C. § 103(a) as obvious over Grassi, Rockland and
Altman.
We also affirm the Examiner’s obviousness rejections of claims 4, 5,
and 6.

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TIME PERIOD
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

cdc

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