Ex Parte Wallace et al

Patent Trial and Appeal Board

Nov 21, 2018

13051738 (P.T.A.B. Nov. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/051,738
90041 7590
Covidien LP
ATTN: IP Legal
5920 Longbow Drive
Mail Stop A36
03/18/2011
Boulder, CO 80301-3299
11/26/2018
FIRST NAMED INVENTOR
Michael P. Wallace
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
10077-720.200 5106
EXAMINER
FOWLER, DANIEL WAYNE
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
11/26/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
covidien@hollandhart.com
rs. patents. two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL P. WALLACE, ROBERT GARABEDIAN,
DAVID S. UTLEY, BRENT C. GERBERDING, and JOHN DE CSEPEL
Appeal2017-007156
Application 13/051,738 1
Technology Center 3700
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS and DAVID
COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device. The Examiner rejected the claims on appeal under 35 U.S.C.
§ 103(a) as obvious and under 35 U.S.C. § 112 as failing to comply with the
written description requirement.
We affirm-in-part.
1 According to Appellants, the real party in interest is Medtronic Inc. App.
Br. 2.
Appeal2017-007156
Application 13/051,738
STATEMENT OF THE CASE
The Specification discloses that "[t]he invention relates to devices that
provide therapy directed to the inner aspect of walls of hollow or lmninal
organs as typically exemplified by organs of the gastrointestinal tract."
Spec. ,r 33. The devices include an operative element, which may be an
electrode array, and which "may be brought into effective contact with a
target, at least in part, by way of a volumetric expansion of a member or
support structure that causes pressing of an operative element against the
target site." Id. ,r,r 33, 34.
The Specification discloses that "[i]f an operative element, such as an
ablation element, is mounted directly on a support structure whose volume
expands, the expansion of the surface area that supports the operative
element can potentially complicate the consistency of energy delivery from
an ablation structure." Id. ,r 33. This is because the surface area on which
the operative element is supported expands, but the operative element itself
may not expand, thus changing the density of energy delivered per unit of
surface area. Id. The claimed device solves this problem by "sectoring an
instrument support surface that is expandable as a whole into at least two
portions, a first portion which supports the ablational instrument and which
expands to a minimal degree, and another portion or portions with which the
instrument is not associated, and which provides the entirety or substantial
majority of the expandability of the support." Id.
Claims 1-5, 7-20,23,24,28-36,38,45,47,50,52,54,55,61,63,64
and 66 are on appeal. Claim 1 is illustrative and reads as follows:
1. A medical device, comprising:
an expandable support member having a first portion and
a second portion, wherein the first portion is arranged such that
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Appeal2017-007156
Application 13/051,738
it occupies an arc orthogonal to a longitudinal axis of the
expandable support member and extends less than a full length
along the longitudinal axis of the expandable support member,
the first portion of the expandable support member having an
exterior surface with a first surface area;
an expansion-resistant reinforcing element having a first
side with a second surface area and a second side opposite the
first side, the second surface area being substantially the same as
the first surface area, the entire first side fixedly coupled with the
exterior surface of the first portion of the expandable support
member, wherein expansion of the first portion is constrained by
at least the expansion-resistant reinforcing element such that the
first portion has a smaller expansion index than that of the second
portion; and
an operative element fixedly coupled with the second side
of the expansion resistant reinforcing element, wherein the
operative element is operative over a third surface area that is
substantially the same as the first surface area.
App. Br. 14.
The claims stand finally rejected by the Examiner as follows.
Claims 14--20 and 28 were rejected under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement.
Claims 1-5, 7-13, 27, 29-36, 38, 45, 47, 50, 52, 54, 61, 63, 64, and 66
were rejected under 35 U.S.C. § I03(a) as obvious over the combination of
Edwards2 and Utley. 3
Claims 23 and 24 were rejected under 35 U.S.C. § I03(a) as obvious
over the combination of Edwards, Utley and Stem. 4
2 Edwards et al., US Patent No. 6,589,238 B2, issued July 8, 2003
("Edwards").
3 Utley et al., US Patent Publication No. 2009/0012512 Al, published Jan. 8,
2009 ("Utley").
4 Stem et al., US Patent Publication No. 2008/0097427 Al, published Apr.
24, 2008 ("Stem").
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Appeal2017-007156
Application 13/051,738
Claims 14--20 were rejected under 35 U.S.C. § I03(a) as obvious over
the combination of Edwards, Utley and Maguire. 5
Claim 28 was rejected under 35 U.S.C. § I03(a) as obvious over the
combination of Edwards, Utley, Maguire and Bonutti. 6
Claim 55 was rejected under 35 U.S.C. § I03(a) as obvious over the
combination of Edwards, Utley and Chin. 7
WRITTEN DESCRIPTION
Appellants do not address the Examiner's written description
rejection. We, therefore, summarily affirm the indefiniteness rejection. See
MANUAL OF PATENT EXAMINING PROCEDURE§ 1205.02 (9th Ed., Rev., Jan.
2018) ("If a ground of rejection stated by the examiner is not addressed in
the appellant's brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it, unless the examiner
subsequently withdrew the rejection in the examiner's answer").
5 Maguire et al., US Patent No. 6,514,249 Bl, issued Feb. 4, 2003
("Maguire").
6 Bonutti, US Patent No. 7,311,719 B2, issued Dec. 25, 2007 ("Bonutti").
7 Chin et al., US Patent Publication No. 2006/0271032 Al, published Nov.
30, 2006 ("Chin").
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Appeal2017-007156
Application 13/051,738
OBVIOUSNESS
Edwards discloses "an apparatus and method for the treatment of
sphincters, and more specifically ... an apparatus and method that treat
esophageal sphincters." Edwards, 1: 11-13. Edwards' apparatus includes an
expandable member, which is illustrated in Figures 9A-9C (reproduced
below).
RarJial Oistribu\bn 46
Fig. 9A
Spim: D1sb'i1Julion 50
Fig. 9C
Figures 9A-9C of Edwards provide a lateral view illustrating radial,
longitudinal, and spiral distribution of electrodes on an expandable member
of Edwards' apparatus. Id. at 3:40-47. As shown in Figures 9A-9C,
electrodes 44 are positioned on expandable members 16. Id. at 7:25-27.
Figure 9A shows electrodes positioned in a radial distribution; Figure 9B
shows a longitudinal distribution; and Figure 9C shows a spiral distribution.
Id. at 7:32-37.
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Appeal2017-007156
Application 13/051,738
Utley discloses "[ d]evices and methods ... for ablational treatment of
regions of the digestive tract in post-bariatric surgery patients who fail to
achieve or maintain the desired weight loss." Utley Abstract. One of the
devices disclosed in Utley includes an expandable balloon, as illustrated in
Figures 57 A-57D (reproduced below).
FIG. 57A
100,
,:_
360 364-~ ·----~
/
/(
105 i'f
"-···-f'
100)
"' 105 f,
FIG. 57B 41 "---{' \
,,;--:;?-1:::;-::::::::;
FIG. 57C
100.,
( 105
FIG. 57D
41 't
,;;;:~:.~-:~
. i~::::~7
t"364
.~/
360
/ --380
"FIGS. 57 A-57D provide perspective views of an ablation device 100 with
an overlapping electrode support 360 furled around an expandable balloon
105." Id. ,r 132. In the embodiment of Figures 57 A-57D, inner edge 362 of
the electrode support 3 60 is attached to the balloon, but the remainder of the
electrode support not connected to the balloon. Id. This allows the electrode
support to furl and unfurl as the balloon inflates and deflates. Id. Thus,
"[a]lthough the circumference of the device as a whole expands with the
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Appeal2017-007156
Application 13/051,738
balloon, the ablational surface itself is non-distensible, and maintains its
electrode density." Id.
Claims 1-5, 7-20, 23, 24, 28-36, 38, 45, 52, 54, 55, 61, 63, and 64
Independent claims 1, 36, and 52, and the claims depending
therefrom, require "an expansion-resistant reinforcing element having a first
side with a second surface area and a second side opposite the first side" in
which "the entire first side" is "fixedly coupled with the exterior surface" of
a portion of an "expandable support member." In finding these claims
obvious, the Examiner found that Edwards disclosed most of the elements of
the claims, but acknowledged that it did not disclose an "expansion-resistant
reinforcing element." Final Act. 8 5. The Examiner found that this element
was supplied by Utley's electrode support 360. Id. The Examiner
concluded that it would have been obvious to "provide the device of
Edwards shown in figure 9B with the plurality of electrodes placed on an
expansion-resistant reinforcing element to maintain the desired electrode
density, as taught by Utley." Id. at 5---6.
The Examiner acknowledged that Utley did not disclose that the entire
first side Utley' s expansion resistant reinforcing element ( electrode support
360) was fixedly coupled with the exterior surface of the expandable support
member (balloon 105). Id. at 6. The Examiner, however, concluded that it
would have been obvious to attach the entire side of the expansion resistant
reinforcing element to the balloon. The Examiner explained:
[W]hile the expandable support member disclosed by Utley is
only connected to the expansion resistant reinforcing element at
a portion of the first side (rather than the entire first side as
8 Office Action mailed June 17, 2016 ("Final Act.").
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Appeal2017-007156
Application 13/051,738
Id.
claimed), this allows the electrodes to be located around the
entire circumference of the expandable support member. The
embodiment of Edwards shown in figure 9B does not disclose
circumferential electrodes, so there is no reason to leave any
portion of the expansion resistant reinforc [ ing] element
unattached from the balloon. In fact there are distinct
disadvantages to bodily incorporation of the partial attachment
of the expansion resistant reinforcing element into the device of
Edwards. For instance, less attachment means a higher chance
that the reinforcing element comes unattached. Further, leaving
one end free increases the probability that the electrode side of
the reinforcing element becomes pointed toward the support
member, if for instance the device is rotated in the esophagus
and the free edges "catches" on tissue and pivots about the
attached side. Therefore, at the time of the invention, it would
have been obvious to one of ordinary skill in the art to construct
the device of Edwards-Utley in such a manner that reduces the
likelihood of undesirable performance, such as unattachement
and improper positioning as discussed above, by attaching the
entire first side of the reinforcing element to the support
member surface.
Appellants argue that "the arrangement of the electrode support and
the balloon in Utley fails to teach or suggest 'the entire first side [ of the
expansion-resistant reinforcing element] fixedly coupled with the exterior
surface of the first portion of the expandable support member,' as recited in
claims 1 and 36." App. Br. 8.
As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
"[T]he examiner bears the initial burden ... of presenting a prima facie case
of unpatentability." Appellant has persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
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Appeal2017-007156
Application 13/051,738
The electrode support 360 of the embodiment depicted in Utley's
Figures 57 A-57D is purposefully attached to the balloon only along its inner
edge 362 so that it can unfurl as the balloon 105 expands. Utley ,r 132.
Attaching the entire surface of Utley' s electrode support to the balloon, as
proposed by the Examiner, would defeat this purpose. We acknowledge that
if only a portion ofUtley's electrode support were used, such that the
electrodes do not extend around the entire circumference of the balloon, it
may not be necessary for Utley's electrode support to unfurl. We further
acknowledge that Edwards discloses an embodiment in which the electrodes
do extend around the entire circumference of the balloon (see Edwards Fig.
9B) and that Utley teaches maintaining electrode density. Utley ,r 132.
However, the Examiner does not identify, and we do not find, a suggestion
in either reference to maintain electrode density on an expandable support
(e.g. a balloon) by preventing a portion of that support from expanding, as is
claimed. Absent such a suggestion, the Examiner has not carried the burden
to establish that it would have been obvious to modify the references in the
manner described by the Examiner. Accordingly, we reverse the Examiner's
rejection of claims 1-5, 7-20, 23, 24, 28-36, 38, 45, 52, 54, 55, 61, 63, and
64.
Claim 47
Claim 4 7 requires a "radio frequency (RF) ablation element having a
first side with a first surface area and the entire first side fixedly coupled
with an exterior surface of a first partially-circumferential portion of the
expandable member ... the RF ablation element adapted to resist expansion
of the first partially-circumferential portion .... " The Examiner analogizes
the electrode support 360 in Utley to the claimed "ablation element," and
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Appeal2017-007156
Application 13/051,738
relies on the same reasoning discussed above in finding that it would have
been obvious to "fixedly couple" the "entire first side" of the ablation
element to a portion of the "expandable member." Final Act. 9.
Accordingly, we reverse the Examiner rejection of claim 47 for the reasons
discussed above.
Claims 50 and 66
Claims 50 and 66 require "an electrode support comprising a flexible,
non-distensible backing and having a first side with a first surface area and a
second side opposite the first side, the entire first side of the electrode
support fixedly coupled with a partially circumferential exterior surface of
the expandable member .... " The Examiner analogizes the electrode support
360 in Utley to the claimed "electrode," and relies on the same reasoning
discussed above in finding that it would have been obvious to "fixedly
couple" the "entire first side" of the electrode support to a surface of the
"expandable member." Final Act. 10. Accordingly, we reverse the
Examiner's rejection of claim 50 and 66 for the reasons discussed above.
SUMMARY
In summary, we affirm the Examiner's rejection of claims 14--20 and 28
under 35 U.S.C. § 112(a) as failing to comply with the written description
requirement.
We reverse the Examiner's rejection of claims 1-5, 7-13, 27, 29-36,
38, 45, 47, 50, 52, 54, 61, 63, 64, and 66 under 35 U.S.C. § 103(a) as
obvious over the combination of Edwards and Utley.
We reverse the Examiner's rejection of claims 23 and 24 under 35
U.S.C. § 103(a) as obvious over the combination of Edwards, Utley and
Stem.
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Application 13/051,738
We reverse the Examiner's rejection of claims 14--20 under 35 U.S.C.
§ 103(a) as obvious over the combination of Edwards, Utley and Maguire.
We reverse the Examiner's rejection of claim 28 under 35 U.S.C.
§ 103(a) as obvious over the combination of Edwards, Utley, Maguire and
Bonutti.
We reverse the Examiner's rejection of claim 55 under 35 U.S.C.
§ 103(a) as obvious over the combination of Edwards, Utley and Chin.
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.
§ 41.50(±).
AFFIRMED-IN-PART
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