Ex Parte Christian

Patent Trial and Appeal Board

Oct 20, 2016

11740163 (P.T.A.B. Oct. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111740, 163 0412512007
137540 7590 10/24/2016
Pearl Cohen Zedek Latzer Baratz LLP
Given Imaging Ltd.
1500 Broadway, 12th Floor
New York, NY 10036
FIRST NAMED INVENTOR
Steven C. Christian
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.
P-71490-US 1619
EXAMINER
TOTH, KAREN E
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
10/24/2016 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):
uspto@pearlcohen.com
medtronic_mitg-et_docketing@cardinal-ip.com
SurgicalUS@covidien.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN C. CHRISTIAN
Appeal2013-005924 1
Application 11/740,1632
Technology Center 3700
Before MICHAEL C. ASTORINO, BRUCE T. WIEDER, and
MATTHEWS. MEYERS, Administrative Patent Judges.
MEYERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 1-35. We have jurisdiction under 35 U.S.C. § 6(b). An
oral hearing was held on October 17, 2016.
We REVERSE.
1 Our decision references Appellant's Appeal Brief ("Appeal Br.," filed
October 1, 2012) and Reply Brief ("Reply Br.," filed March 18, 2013), and
the Examiner's Answer ("Ans.," mailed January 17, 2013) and Final Office
Action ("Final Act.," mailed March 1, 2012).
2 Appellant identifies Given Imaging, Ltd., as the real party in interest
(Appeal Br. 1).
Appeal2013-005924
Application 11/740,163
CLAIMED INVENTION
Appellant's invention relates "to medical devices for monitoring
physiological conditions within a body lumen" (Spec. i-f 2).
Claims 1, 18, 29, and 33 are the independent claims on appeal.
Claim 1, reproduced below with added bracketed notations, is illustrative of
the subject matter on appeal:
1. A device comprising:
[a] an elongated probe configured to carry an implantable
capsule for deployment within a patient;
[b] an anchor element configured to anchor the capsule to
tissue within the patient;
[ c] a vacuum chamber;
[ d] a release mechanism configured to release the capsule
from the probe; and
[ e] an actuator configured to activate the anchor element
to cause the anchor element to anchor the capsule to the tissue
during a first motion of the actuator, and activate the release
mechanism to vent the vacuum chamber and to release the
capsule from the probe during a second motion of the actuator.
Appeal Br. (Claims. App.).
REJECTIONS
Claims 1-3, 6, 7, 11, 12, 17-20, 22, 25-31, and33-35 are rejected
under 35 U.S.C. § 103(a) as unpatentable over Kilcoyne (US 2004/0158138
Al, pub. Aug. 12, 2004) and Eerdmans (US 2004/0215128 Al, pub. Oct. 28,
2004).
Claims 4, 5, 8-10, 21, 23, and 24 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kilcoyne, Eerdmans, and Cros (US 7,621,036
B2, iss. Nov. 24, 2009).
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Application 11/740,163
Claims 13 and 14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kilcoyne, Eerdmans, and Gerber (US 2010/0131016 Al,
pub. May 27, 2010).
Claims 15, 16, and 32 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kilcoyne, Eerdmans, and Sauer (US 2005/0165419 Al,
pub. July 28, 2005).
ANALYSIS
Independent claim 1 and dependent claims 2, 3, 6, 7, 11, 12, and 17
We are persuaded by Appellant's argument that the Examiner erred in
rejecting independent claim 1under35 U.S.C. § 103(a) because the
combination of Kilcoyne and Eerdmans fails to disclose or suggest
limitation [ e] of independent claim 1 which recites
an actuator configured to activate the anchor element to cause the
anchor element to anchor the capsule to the tissue during a first
motion of the actuator, and activate the release mechanism to
vent the vacuum chamber and to release the capsule from the
probe during a second motion of the actuator.
(See Appeal Br. 4--9; see also Reply Br. 1--4).
In rejecting claim 1under35 U.S.C. § 103(a), the Examiner relies on
Kilcoyne as disclosing "an actuator configured to activate the anchor
element to cause the anchor element to anchor the capsule to the tissue
during a first motion of the actuator (element 148), and activates the release
mechanism to release the capsule from the probe during a second motion of
the actuator" (Final Act. 2 (citing Kilcoyne i-f 104)), but finds that "Kilcoyne
does not disclose the second motion of the actuator also venting the vacuum
chamber" (Final Act. 2). The Examiner also acknowledges that "Kilcoyne
does not provide any details as to how vacuum is controlled during operation
of the device" (id.). To address these deficiencies, the Examiner turns to
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Application 11/740,163
Eerdmans (id. at 3 ). More particularly, the Examiner relies on Eerdmans as
disclosing
an actuator (element 44), where movement of the actuator in first
and second motions causes anchoring of the capsule of the tissue
and release of the capsule from the probe, and movement of the
actuator also controls the application of vacuum to the vacuum
chamber and overall device, with movement of the actuator
controlling alignment of the chamber with a vacuum inlet, and
movement of the actuator after anchoring causes the chamber's
inlet to be aligned with inlet 34, allowing venting that is
inherently necessary to allow the capsule to detach from the
probe (see figures 4A-D and 5A-D), in order to precisely control
capsule deployment with minimal operator actions.
(Id.). Based on the disclosures of Kilcoyne and Eerdmans the Examiner
concludes
(Id.).
[i]t would have been obvious to one of ordinary skill in the art at
the time the invention was made to have made the device of
Kilcoyne with the actuator configured to also control application
of vacuum, as taught by Eerdmans, in order to allow precise
control with minimal operator actions.
However, we agree with Appellant that the cited portions of
Eerdmans, in combination with Kilcoyne, fail to disclose or suggest "an
actuator configured to ... activate the release mechanism to vent the
vacuum chamber and to release the capsule from the probe during a second
motion of the actuator," as recited in limitation [ e] of independent claim 1
(see Appeal Br. 6-9; see also Reply Br. 1--4).
In making this determination, we note that Kilcoyne is directed to a
"to an implantable probe for monitoring one or more parameters in the
esophagus" (Kilcoyne i-f 2). Kilcoyne discloses that its device includes "a
housing, a concavity on the housing, and a pin which is axially movable
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Appeal2013-005924
Application 11/740,163
from a retracted position within the housing to an extended position which
extends at least part way across the concavity" (id. i-f 18). Kilcoyne further
discloses "a vacuum lumen in communication with the concavity, and the
drawing tissue into the concavity step additionally comprises the step of
applying suction to the lumen" (id. i-f 17). Kilcoyne also discloses that
"[f]ollowing deployment of the pin 164 . .. , the proximal control 186 is
manipulated to proximally retract the sleeve 184, thereby opening collet 168
to release the docking structure 126" (id. i-f 104).
Eerdmans is directed to a delivery device which "includes a handle
and a flexible probe that extends from the handle into the esophagus of the
patient," and a capsule which "is coupled to a distal end of the probe for
delivery to a particular location within the esophagus" (id. i-f 9). Eerdmans
discloses that its
delivery device includes a vacuum inlet on the handle to couple
the delivery device to a vacuum. The vacuum applies suction
\'l1ithin an inner lumen formed by the probe. ii~ vacuum outlet at
the distal end of the probe and, more particularly, at the interface
between the probe and the capsule, applies suction from the
vacuum to the wall of the esophagus in order to draw esophageal
tissue of the wall into a void within the capsule. The delivery
device anchors the capsule to the esophageal tissue drawn into
the void of the capsule and disengages from the capsule thereby
leaving the capsule attached to the wall of the esophagus. The
delivery device may, for example, advance a locking pin through
the esophageal tissue captured in the void to anchor the capsule
to the wall of the esophagus.
(Id. i-f 11 ).
Eerdmans delivery device includes a"[ c ]ontroller 44 [which] may
comprise a plunger that is successively pushed through different stages to
perform sequential operations during the delivery of capsule 18 to the
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Application 11/740,163
appropriate location along esophagus 14" (id. if 35). Eerdmans further
discloses that "controller 44 can be adjusted to cause a shaft 48 to advance a
locking pin (not shown) through the esophageal tissue within void 46 in
order to anchor sensing capsule 18 to a wall of esophagus 14" (id. if 39).
Eerdmans also discloses that
[p ]lunger 56 is advanced another stage further, in tum contacting
and advancing shaft 48 to drive a locking pin or other anchor
mechanism through the esophageal tissue in void 46 of capsule
18 in order to anchor capsule 18 to esophagus 14 (FIG. 4(D)).
Delivery device 22 may then be removed from esophagus 14 of
patient 12.
(Id. if 48).
In response to Appellant's arguments (see Appeal Br. 4--9), the
Examiner states
Eerdmans clearly teaches a first actuator motion to anchor the
tissue (forward motion of element 48 - figures 4A-D and 5A-C)
and a second actuator motion that vents the vacuum and allows
release of the capsule (figure 5D; which shows retraction; and
figures 4A-D which, taken in reverse, show opening of the
vacuum port as part of capsule release).
(Ans. 22). The difficulty with the Examiner response, as Appellant points
out, is "Eerdmans is silent with respect to the relationship between venting
and the detachment of the capsule, and the relationship between the
movement of plunger 56 (the actuator) and the detachment of the capsule"
(Reply Br. 2). In this regard, Eerdmans discloses that "[p ]lunger 56 is
advanced another stage further, in tum contacting and advancing shaft 48"
(Eerdmans if 48)), and as such, we agree with Appellant that because "the
plunger is not apparently attached to the shaft 48 it is not clear how the shaft
is retracted" (id.). Thus, we find the Examiner's statement that
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Application 11/740,163
Figure 5D does not have a corresponding illustration in figure 4
to show the position of the components in the handle during
retraction of element 48 (the second actuator motion); however,
retraction of element 48 would merely be a reversal of the stages
shown in figures 4A-D. Figure 5D clearly shows that element
48 is retracted as part of release. As such, when reversing the
stages, port 34 would be opened, thereby allowing release of the
vacuum
(Ans. 21) to be based on speculation unsupported by the Eerdmans'
disclosure. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) ("The
Patent Office has the initial duty of supplying the factual basis for its
rejection. It may not, because it may doubt that the invention is patentable,
resort to speculation, unfounded assumptions or hindsight reconstruction to
supply deficiencies in its factual basis.").
The Examiner further reasons
[i]n order to function, the c-shaped portion of the distal end of
element 26 which surrounds the probe (unlabeled in figures SA-
D) must be airtight, since any leakage of the vacuum would make
it difficult, if not impossible, to create enough vacuum to break
element 42 and draw tissue into chamber 46. However, if the
vacuum is not released, the components would be held in place
and the delivery device would not be able to be removed.
(Id. at 22). However, as Appellant points out, "[i]n the configurations
shown in figures 4(A) and 5(A) no vacuum is applied" (Reply Br. 2) to
retain the capsule 18 in the distal end of probe 26 while introducing the
probe into the patient (see Eerdmans i-f 45), and thus, "[s]ome other
mechanism, not described, retains the capsule with respect to the probe"
(Reply Br. 2). We also note that Eerdmans simply discloses that "[t]he
capsule is coupled to a distal end of the probe for delivery to a particular
location within the esophagus" (Eerdmans i-f 9; see also id. i-f 2). Therefore,
in the absence of any evidence and/or technical reasoning to the contrary, we
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Application 11/740,163
agree with Appellant that because "neither the vacuum nor the shaft 48 is
responsible for retaining the capsule with respect to the probe" (Reply Br. 2)
during placement, "[a]ny argument that allowing venting through actuator
movement is inherently necessary to allow the capsule to detach is baseless,
as there are any number of ways (all undescribed) that detachment could be
achieved in Eerdmans" (id. at 2-3). We note the Examiner does not rely on
Kilcoyne to cure this deficiency.
In view of the foregoing, we do not sustain the Examiner's rejection
of independent claim 1under35 U.S.C. § 103(a) as unpatentable over
Kilcoyne and Eerdmans. For the same reasons, we also do not sustain the
Examiner's rejection of dependent claims 2, 3, 6, 7, 11, 12, and 17 which
depend from independent claim 1.
Independent claims 18, 29, and 33, and dependent claims 19, 20, 22, 25-28,
30, 31, and 33-35
Independent claims 18, 29, and 33 include a limitation substantially
similar to independent claim 1 's limitation [ e] discussed above. Therefore,
we do not sustain the Examiner's rejection under 35 U.S.C. § 103(a) of
independent claims 18, 29, and 33, and claims 19, 20, 22, 25-28, 30, 31, and
33-35 that depend therefrom, for the same reasons set forth above with
respect to independent claim 1.
Dependent claims 4, 5, 8-10, 13-16, 21, 23, 24, and 32
Claims 4, 5, 8-10, 13-16, 21, 23, 24, and 32 depend, directly or
indirectly, from one of independent claims 1, 18, and 29, and thus,
incorporate limitation [ e] recited in independent claim 1 or the similar
limitations recited in independent claims 18 and 29. The Examiner's
rejections with respect to Cros, in combination with Kilcoyne and Eerdmans,
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Application 11/740,163
as applied to claims 4, 5, 8-10, 21, 23, and 24; Gerber, in combination with
Kilcoyne and Eerdmans, as applied to claims 13 and 14; and Sauer, in
combination with Kilcoyne and Eerdmans, as applied to claims 15, 16, and
32, do not cure the above-discussed shortcomings of Kilcoyne and Eerdmans
identified by Appellant. Thus, we do not sustain the Examiner's rejections
of dependent claims 4, 5, 8-10, 13-16, 21, 23, 24, and 32 under 35 U.S.C.
§ 103(a) for the same reasons set forth above with respect to independent
claim 1.
DECISION
The Examiner's rejections of claims 1-35 under 35 U.S.C. § 103(a)
are not sustained.
REVERSED
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