Ex Parte Walters et al

Patent Trial and Appeal Board

Jan 25, 2019

14569291 (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
14/569,291
103199 7590
OFFIT KURMAN
FILING DATE
12/12/2014
01/29/2019
8171 Maple Lawn Boulevard
Suite 200
Fulton, MD 20759
FIRST NAMED INVENTOR
Greg A. Walters
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.
04840003.00035 6034
EXAMINER
HIGHLAND, RACHEL S
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
01/29/2019 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):
eofficeaction@appcoll.com
patentdocket@offitkurman.com
patents@offitkurman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GREG A. WALTERS, GARY ROUBIN, MICHAEL THOMAS
NISPEL, MICHAEL AUSTIN DOT SEY, and PIYUSH ARORA 1
Appeal 2018-001340
Application 14/569,291
Technology Center 3700
Before MICHAEL L. HOELTER, JEREMY M. PLENZLER, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from the
Examiner's Final Rejection of claims 1-9, 11-13, 16-27, and 31-36. Br. 1.
We have jurisdiction under 35 U.S.C. § 6(b). For the reasons explained
below, we REVERSE the Examiner's rejection of these claims.
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates generally to closing
percutaneous punctures." Spec. ,r 2. Apparatus claims 1 and 16 are
1 "The real party in interest is the appellant-applicant, Essential Medical
Inc." Br. 1. We thus proceed on the basis that, for purposes of this appeal,
Essential Medical Inc. is the "Appellant."
Appeal 2018-001340
Application 14/569,291
independent. Claim 1 is illustrative of the claims on appeal and is
reproduced below.
1. A deployment instrument configured to seal a
percutaneous puncture in a wall of an artery, the deployment
instrument configured to slide along a guide wire positionable
through the puncture, the deployment instrument comprising:
a closure device including a toggle and a plug connected
to the toggle, the toggle defining a distal surface, an opposed
proximal surface, and a cavity that extends from the distal
surface to the proximal surface, the cavity sized and configured
to receive the guide wire so that at least the toggle is slidable
along the guide wire when the guide wire is 1) received by the
cavity, and 2) is positioned to extend through the percutaneous
puncture;
a handle member;
a delivery component that is supported by the handle
member and that extends relative to the handle member in a distal
direction;
a release component supported by the handle member and
extending relative to the handle member along the delivery
component in the distal direction; and
an actuator supported by the handle member and operably
coupled to the delivery component and the release component,
the actuator configured to actuate at least one of the delivery
component and the release component from a first state where
the toggle is fixed between the distal end of the delivery
component and the release component, into a second state where
the toggle is released from between the distal end of the delivery
component and the release component.
REFERENCES RELIED ON BY THE EXAMINER
Kensey et al.
Nash et al.
Ginn
us 5,282,827
us 5,662,681
US 2003/0078616 Al
2
Feb. 1, 1994
Sept. 2, 1997
Apr. 24, 2003
Appeal 2018-001340
Application 14/569,291
THE REJECTION ON APPEAL
Claims 1-9, 11-13, 16-27, and 31-36 are rejected under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Nash (which incorporates Kensey by
reference) and Ginn.
ANALYSIS
Appellant argues independent claim 1 (Br. 5-14) separate from
independent claim 16 (Br. 15-17) because of their different recitations. See
Br. 17. The Examiner rejects both independent claims employing the same
rationale. Final Act. 3--4. We address these two claims as follows.
Claim 1, unlike claim 16, recites a toggle that "is slidable along the
guide wire." The Examiner acknowledges that "Nash does not teach" this
limitation and relies on Ginn for such teaching. Final Act. 4. The Examiner
states that it would have been obvious "to add a guidewire ... as taught by
Ginn" to ensure proper sealing and easy navigation of the toggle to the
proper position. Final Act. 4.
Nash discloses a toggle 32 that is navigated to the proper position
within a body lumen and employed to seal a puncture from within that
lumen. See, e.g., Nash Abstract and Figures. The Examiner is not
expressive as to why Nash needs additional structure (i.e., "add a
guidewire") to achieve what is already accomplished without such additional
structure.
Further, Appellant contends that "Nash-Kensey and Ginn are not
capable of performing the function recited in the claims" and that "the
proposed modification of Nash-Kensey with Ginn is not proper because it
would destroy Nash-Kensey's principle of operation." Br. 10.
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Appeal 2018-001340
Application 14/569,291
There is merit to these concerns because Nash itself is wholly silent as
to any "guide wire" and Kensey (which Nash incorporates by reference)
teaches that any guide wire employed in an initial procedure is removed
prior to insertion of the toggle into the patient. See Kensey 4:45-55; see
also Br. 11-12. Hence, the Examiner's reason to "add a guidewire" (Final
Act. 4) must be either based on hindsight (because Nash is silent on this
point) or such addition would run counter to the teachings of Kensey (which
removes the guide wire prior to toggle insertion). See supra. We thus agree
with Appellant's assertion that "Nash-Kensey discloses neither the structure
for receiving a guidewire nor the capability to slide along a guidewire even
if one knew to do so." Br. 11. This is because "Nash-Kensey's instrument
is designed to be inserted inside an empty introducer sheath and not inside
an introducer sheath that has a guidewire in place." Br. 12. Accordingly,
we are not persuaded the Examiner has provided articulated reasoning with
rational underpinning to support a legal conclusion of obviousness. We do
not sustain the Examiner's rejection of independent claim 1, or its dependent
claims 2-9, 11-13, 31-33, and 36, as being obvious over Nash and Ginn.
In addition to the above, both independent claim 1 and 16 recite an
"actuator" that is configured to actuate a "release component" from a first
state to a second state. Regarding the recited "actuator," the Examiner
states, "[ s Jee gripping sections of device of Kensey," and regarding the
"release component," the Examiner correlates this to item 104 (both Nash
and Kensey identify item 104 as a "bypass tube"). Final Act. 3.
Kensey does not employ the word "grip" or "gripping," but
nevertheless, we understand Kensey' s "gripping sections" to be the portion
of Kensey's instrument 20 that is illustrated in Figure 19 as being gripped by
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Appeal 2018-001340
Application 14/569,291
the hand of a user. Within this gripping section/actuator of Kensey's
instrument 20 (i.e., within luer fittings 110, 112), is a tensioning assembly,
which tensions filament 34. See Kensey 8:40-45; 12:64---66 ("tensioner
assembly described heretofore controls the force on the filament 34 during
the retraction procedure"); Fig. 1. This filament 34 extends through
instrument 20 and is secured to toggle 32 located (pre-deployment) within
bypass tube 104. 2 See Kensey 8:20-22, Figs. 5, 11.
Hence, as we understand the Examiner's rejection, Nash/Kensey is
relied on to teach an actuator (Kensey's "gripping sections") configured to
actuate ( or "cause" ( claim 16)) a release component (bypass tube 104) to
transition from a first state to a second state. Because, as discussed above,
Kensey's gripping section/actuator is designed to control tension on filament
34, which passes into and through bypass tube 104 (filament 34 is used to
position toggle 32 within a patient's artery), the Examiner does not make
clear how Kensey's gripping section/actuator actuates or causes the bypass
tube to translate between states as recited. 3 Instead, any movement of
bypass tube 104 is due to a user's manual manipulation of instrument 20 as a
whole, and is not due to any operation of Kensey's actuators as recited. See
Kensey 8:7-13; 12:2--4 ("[t]he bypass tube 104 remains within the portion of
the introducer sheath housing the hemostasis valve 28A"); 12:50-52 ("[t]o
that end the introducer sheath 28 and the instrument 20 are held together and
withdrawn as a unit from the puncture"). Accordingly, the Examiner has not
2 For clarity, Appellant's Specification makes a distinction between a
filament and a guide wire. See Spec. ,r,r 41, 54, Fig. 3B.
3 Appellant contends "the gripping section/proximal end on the instrument
does not cause the bypass tube 104 to transition from [a] first state to a
second state." Br. 15.
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Appeal 2018-001340
Application 14/569,291
established by a preponderance of the evidence that Nash (or the
Nash/Kensey combination) can be properly relied upon for disclosing the
above recited limitation (Ginn is relied on for other reasons and does not
cure this defect). Thus, we do not sustain the Examiner's rejection of
independent claims 1 and 16, or of dependent claims 2-9, 11-13, 17-27, and
31-36.
DECISION
The Examiner's rejection of claims 1-9, 11-13, 16-27, and 31-36 is
reversed.
REVERSED
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