Ex Parte Stancer et al

Patent Trial and Appeal Board

Jul 15, 2013

11669519 (P.T.A.B. Jul. 15, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte CHRISTOPHER C. STANCER and MICHAEL D. FLETCHER
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Appeal 2011-007671
Application 11/669,519
Technology Center 3700
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Before PHILLIP J. KAUFFMAN, PATRICK R. SCANLON, and
BART A. GERSTENBLITH, Administrative Patent Judges.

GERSTENBLITH, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Christopher C. Stancer and Michael D. Fletcher (“Appellants”) appeal
under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 1-20.
We have jurisdiction under 35 U.S.C. § 6(b).
The Claimed Subject Matter
Claims 1 and 19 are the independent claims on appeal. Claim 1 is
representative of the claimed subject matter and is reproduced below.
1. A subcutaneous cardiac activity sensing device,
comprising:
an implantable medical device (IMD), wherein an
exterior surface of the periphery of the IMD housing is rendered
electrically insulative;
a shroud member mounted to the insulated exterior
surface of the periphery of the IMD;
a header portion subsequently coupled to the shroud
member and to a portion of the periphery of the IMD;
at least one electrically insulated elongated conductor
coupled to a hermetic feedthrough pin disposed between the
IMD housing and the header portion; and
at least one electrode mechanically coupled to the
elongated conductor and the shroud member.
App. Br. 9 (Claims App’x, Claim 1). Claim 19 is directed to a “method of
fabricating a cardiac sensing shroud assembly,” comprising, inter alia,
“providing a resilient shroud member adapted to be mounted around at least
a part of the insulative peripheral portion of the housing.” Id. at 11 (Claims
App’x, Claim 19).
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References
The Examiner relies upon the following prior art references:
Wiklund US 5,431,695 July 11, 1995
Byland US 5,456,698 Oct. 10, 1995
Garcia US 5,480,416 Jan. 2, 1996
Davidson US 5,496,359 Mar. 5, 1996
Swanson US 6,212,426 B1 Apr. 3, 2001
Ceballos US 6,522,915 B1 Feb. 18, 2003
Webber US 6,616,614 B2 Sept. 9, 2003
Rejections
The Examiner makes the following rejections under 35 U.S.C.
§ 103(a):
I. Claims 1-4, 13-15, and 18-20 are rejected as being unpatentable
over Ceballos and Garcia;
II. Claims 5 and 6 are rejected as being unpatentable over
Ceballos, Garcia, and Davidson;
III. Claims 7 and 17 are rejected as being unpatentable over
Ceballos, Garcia, Davidson, and Wiklund;
IV. Claim 8 is rejected as being unpatentable over Ceballos, Garcia,
Davidson, Wiklund, and Swanson;
V. Claims 9-11 are rejected as being unpatentable over Ceballos,
Garcia, and Wiklund;
VI. Claim 12 is rejected as being unpatentable over Ceballos,
Garcia, and Byland; and
VII. Claim 16 is rejected as being unpatentable over Ceballos,
Garcia, and Webber.
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SUMMARY OF DECISION
We AFFIRM.
OPINION
Rejection I1
The Examiner found that Ceballos discloses the elements of the
claims, except that it “does not disclose that the exterior surface of the IMD
housing is rendered electrically insulative with a parylene material.” Ans.
3-4. The Examiner found that Garcia teaches “an implantable cardiac
pacemaker with a parylene coating to render the majority of the housing
electrically insulative.” Id. at 4. The Examiner determined that it would
have been obvious to one of ordinary skill in the art at the time of invention
to add a parylene coating as taught by Garcia to the IMD as disclosed by
Ceballos “in order to render the housing electrically Insolative, [sic] and
then additionally add the shroud as disclosed by Ceballos . . . in order to
provide additional leadless electrodes.” Id.
Appellants assert that the Examiner erred in finding that Garcia
“teaches parylene coating of the device housing before attachment of the
connector block, resulting in an insulating layer between the device housing
and the connector block.” App. Br. 5. Appellants assert that one of
ordinary skill in the art would understand that the parylene coating in Garcia
is applied “after the header is attached.” Id. at 6. According to Appellants,

1 Appellants present a single argument for all of the claims on appeal,
mentioning independent claims 1 and 19, but not distinguishing between the
subject matter of these claims. App. Br. 5-7; Reply Br. 2-5. Thus, we select
independent claim 1 as representative, and claims 2-4, 13-15, and 18-20 rise
or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii) (2011).
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because Garcia is coated after the header is attached, coating the device of
Ceballos in the same manner, would result in “a parylene coating
everywhere except beneath the shroud and header of Ceballos, directly
contrary to the Examiner’s argument.” Id.; see Reply Br. 2 (“As Garcia
doesn’t disclose applying the coating before applying the header of Garcia, it
correspondingly does not suggest applying it before attachment of the
shroud of Ceballos.”). Because Garcia “expressly teaches the opposite of
the Examiner’s argument,” Appellants contend that it “teaches directly away
from the claimed invention.” Id. at 7.
Appellants also rely upon U.S. Patent No. 5,925,069 (the “’069
patent”). Id. at 6. Appellants contend that in the ’069 patent “it is expressly
stated that the parylene coating as set forth in Garcia is applied after
mounting the header to the metallic enclosure.” Id. Thus, Appellants assert
that the ’069 patent “confirms what Garcia means . . . when it expressly
teaches coating the ‘entire’ device.” Id. at 7.
Additionally, Appellants contend that coating the entire housing
before attaching the shroud would result in coating all of the device’s
feedthroughs. Id. Coating the feedthroughs would “interfere with the
electrical interconnection of the device’s feedthroughs to the electrode
conductors and to the electrical connectors in the header.” Id. Thus,
Appellants assert that the Examiner’s finding is contrary to common sense
regardless of the teaching of Garcia. Id.
Garcia discloses “a conventional pulse generator 1 for a cardiac
pacemaker . . . adapted for implantation into a patient.” Garcia, col. 4,
ll. 3-5. The pulse generator “has an electrically conductive case 2 that
houses the electronics for the generator” and a “header 3 composed of
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transparent epoxy resin” that is mounted atop the case. Id. at col. 4, ll. 6-8,
12-13; figs. 1-3. Garcia explains that to avoid sensitivity to pectoral muscle-
induced potentials and twitching caused by muscle stimulation “the case is
coated by the manufacturer with a thin, electrically insulating layer 7 of
parylene.” Id. at col. 4, ll. 38-42.
Garcia discloses two embodiments. In one embodiment, best shown
in Figure 1, Garcia discloses that “[t]he entire surface of the case 2 is
coated—back side, front side, and connecting edge—except for a small
centrally located portion or window 8 on the front side which serves as an
uninsulated anodal contact surface for pacing.” Id. at col. 4, ll. 42-46
(emphasis added). In another embodiment, generally shown in Figures 4-7,
Garcia discloses that “the entire surface of the case is coated with an
electrically insulative, biocompatible film except along a portion of the edge
of the case between its two major sides . . . .” Garcia, Abstract (emphasis
added); see id. at col. 3, ll. 36-40 (“A related object is to coat the entire
surface of the case with an electrically insulative, biocompatible film except
along a portion of the edge of the case between its two major sides which is
to serve as an anodal contact surface for stimulating and sensing cardiac
activity of the patient”) (emphasis added); see id. at col. 4, ll. 59-67 (“In the
embodiment of the invention shown in FIGS. 4, 5, and 6, . . . the thin layer
17 of parylene covers the front and back sides of the case, but not at least a
strip 18 of the edge of the case that connects the two sides.”).
In at least the first embodiment disclosed in Garcia, as reflected in
Figure 1, the only surface of the case not coated with parylene is “a small
centrally located portion or window 8 on the front side.” Id. at col. 4,
ll. 42-46; fig. 1. The header, however, sits atop the case and thus the surface
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between the case and header does not include the window. See, e.g., id. at
fig. 1. Accordingly, the most reasonable understanding, by one of ordinary
skill in the art, is that the surface of the case on which the header sits is
coated with parylene.2
For completeness, we address Appellants’ citation of the ’069 patent.
Figure 1A of the ’069 patent is nearly identical to Figure 1 of Garcia.
Compare ’069 Patent, fig. 1A with Garcia, fig. 1 (Figure 1A of the ’069
patent includes an additional element 9 indicating an “exposed metal
surface”); see ’069 Patent, col. 6, l. 13. Thus, the ’069 patent also discloses
the first embodiment of Garcia, in which we found Garcia to disclose
parylene on the exterior surface of the case upon which the header sits.
Appellants assert that the ’069 patent “expressly stated that the parylene
coating as set forth in Garcia is applied after mounting the header to the
metallic enclosure.” App. Br. 6. Appellants fail to identify by column and
line where this teaching is allegedly “expressly stated.” See id. at 6; Reply
Br. 3. Subsequently, Appellants move away from asserting that Garcia
expressly states that the coating is applied after the header is attached to the
IMD by instead contending that Garcia discloses that the coating is applied
to the housing “at some time” with relation to attachment of the header.
Reply Br. 2. From our review of the ’069 patent, we are unable to find any
disclosure that comes even remotely close to indicating such an express

2 Because of our findings with respect to the first embodiment of Garcia, we
need not address whether Garcia’s second embodiment similarly contains
parylene on the surface of the case on which the header sits although
Garcia’s disclosure as cited above indicates that the surface similarly
contains parylene because the only surface that does not is a portion of the
edge.
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statement or a specific order of assembling the device. The ’069 patent
reaffirms our finding regarding the first embodiment of Garcia.
Accordingly, we are not persuaded that the ’069 patent supports Appellants’
argument.
We are similarly not persuaded by Appellants’ assertion that coating
the entire case before attachment of the shroud would result in coating the
device’s feedthroughs and would interfere with the electrical
interconnections. See App. Br. 7. As the Examiner noted, Appellants’
Specification also discloses that a parylene coating can be added to the
outside of the IMD housing “using a simple spraying procedure and/or dip
coating.” Spec., para. [15]; see Ans. 12. Appellants’ Specification,
however, does not identify this alleged problem or how such problem would
be solved. Thus, even assuming such a problem were to exist, it appears that
Appellants’ invention would be similarly vulnerable.3
For the reasons explained above, the Examiner’s finding—that Garcia
teaches parylene coating on the exterior surface of the case on which the
header sits—is supported by a preponderance of the evidence.

3 We see no reason why one of ordinary skill in the art could not coat the
case surface with parylene and yet leave the feedthroughs uncoated such that
when the shroud is attached to the case on a parylene coated surface (an
example of an insulated exterior surface as claimed) the feedthroughs are
functional. “A person of ordinary skill is also a person of ordinary
creativity, not an automaton.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398,
421 (2007); see also Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d
1324, 1329 (Fed. Cir. 2009) (“[W]hile an analysis of obviousness always
depends on evidence that supports the required Graham factual findings, it
also may include recourse to logic, judgment, and common sense available
to the person of ordinary skill that do not necessarily require explication in
any reference . . . .”).
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Accordingly, we sustain Rejection I.
Rejections II – VII
As noted above, Appellants present a single argument for all of the
claims on appeal. Accordingly, for the reasons explained in the context of
Rejection I, we sustain Rejections II – VII.
DECISION
We AFFIRM the Examiner’s decision rejecting claims 1-20.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED

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