Ex Parte Javois

Patent Trial and Appeal Board

Jul 19, 2018

11245421 (P.T.A.B. Jul. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/245,421 10/07/2005 Alex Javois
22428 7590 07/23/2018
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
052309-0101 2639
EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
07/23/2018 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEX JA VOIS
Appeal 2016-007 653
Application 11/245,421
Technology Center 3700
Before STEFAN STAICOVICI, CHARLES N. GREENHUT, and
ERIC C. JESCHKE, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE-
Alex Javois ("Appellant") 1 appeals under 35 U.S.C. § 134(a) from the
Examiner's decision in the Final Office Action (dated June 17, 2015,
hereinafter "Final Act.") rejecting claims 1, 5, 15, 23, 27, 29, 30, 33, and 44--
47.2 Appellant's representative presented oral argument on July 10, 2018.
We have jurisdiction over this appeal under 35 U.S.C. § 6(b).
1 Dr. Alex Javois, the inventor, is identified as the real party in interest in
Appellant's Appeal Brief (filed Feb. 2, 2016, hereinafter "Appeal Br.").
Appeal Br. 2.
2 Claims 2--4, 6-14, 16-22, 24--26, 28, 31, 32, 34--43, and 48 are canceled.
See Appeal Br. 17-19 (Claims App.).
Appeal 2016-007653
Application 11/245,421
We REVERSE.
SUMMARY OF DECISION
INVENTION
Appellant's invention relates to a device "for occluding the left atrial
appendage." Spec. para. 25.
Claim 1, the sole independent claim, is representative of the claimed
invention and reads as follows:
1. A left atrial appendage occlusion device comprising:
a deformable wire having a proximal portion and a distal
portion, wherein the deformable wire is configured to form a
first predetermined expanded shape and a second predetermined
relaxed shape;
a distal anchor that includes a plurality of hooks or barbs
extending from a point at an overall distal end of the
deformable wire, the distal anchor being configured to attach
the device to an interior wall of the left atrial appendage; and
a sheet attached to the proximal portion of the
deformable wire,
wherein the deformable wire and sheet are configured
such that, when the deformable wire forms the first
predetermined expanded shape:
(i) the deformable wire has a substantially
linear shape,
(ii) a length of the sheet is substantially greater
than a width of the sheet, the length of the sheet
extending in about the same direction as a
longitudinal direction of the deformable wire, and
(iii) the width of the sheet extends in a flagged
manner from the deformable wire in about a
normal direction from the longitudinal direction of
the deformable wire, and
wherein the deformable wire and sheet are configured
such that, when the deformable wire forms the second
predetermined relaxed shape:
2
Appeal 2016-007653
Application 11/245,421
(i) the deformable wire has a shape of a single
substantially conical helix that includes a plurality
of orbits that become progressively larger in a
direction from the overall distal end of the
deformable wire to an overall proximal end of the
deformable wire, a distal-most orbit having a
smallest diameter among the plurality of orbits and
being adjacent to the distal anchor,
(ii) a proximal orbit of the deformable wire has
a diameter greater than a diameter of an opening of
the left atrial appendage to be occluded, and
(iii) the proximal orbit of the deformable wire is
completely eclipsed by overlapping sections of the
sheet.
REJECTIONS
I. The Examiner rejects claims 1, 5, 15, 23, 33, and 44 under 35 U.S.C.
§ I03(a) as being unpatentable over Baccaro (US 6,010,517, issued
Jan. 4, 2000) and Shaw et al. (US 6,080,182, issued June 27, 2000,
hereinafter "Shaw").
II. The Examiner rejects claim 27 under 35 U.S.C. § I03(a) as being
unpatentable over Baccaro, Shaw, and Van Tassel et al. (US
2004/0127935 Al, published July 1, 2004, hereinafter "Van Tassel").
III. The Examiner rejects claim 29 under 35 U.S.C. § I03(a) as being
unpatentable over Baccaro, Shaw, Van Tassel, and Wallace et al. (US
2002/0002382 Al, published Jan. 3, 2002, hereinafter "Wallace").
IV. The Examiner rejects claim 30 under 35 U.S.C. § I03(a) as being
unpatentable over Baccaro, Shaw, and Wallace.
V. The Examiner rejects claims 45--47 under 35 U.S.C. § I03(a) as being
unpatentable over Baccaro, Shaw, and Huebsch et al. (US 5,853,422,
issued Dec. 29, 1998, hereinafter "Huebsch").
3
Appeal 2016-007653
Application 11/245,421
ANALYSIS
Rejection I
The Examiner finds that the combined teachings of Baccaro and Shaw
disclose the structure of"[ a] left atrial appendage occlusion device," as
called for by independent claim 1. See Final Act. 4---6. According to the
Examiner,
Baccaro discloses an occluding device having a conical helix
configuration that is adaptable to fit the device within vascular
regions of varying diameters making the device of Baccaro in
view of Shaw nearly identical in structure of the present
invention and fully capable of being used as claimed if one so
desires to do so.
Examiner's Answer 3 (dated June 30, 2016, hereinafter "Ans.").
Appellant argues that "[ t ]he devices of Baccaro and Shaw are not
intended for use in the left atrial appendage, nor are they capable of acting as
left atrial appendage occlusion devices." Appeal Br. 8.
In response, the Examiner takes "the position that mere statements of
intended use and/ or other functional statements do not impose any structural
limitations on the claims distinguishable over the device of Baccaro in view
of Shaw which is capable of being used as claimed if one so desires to do
so." Ans. 2.
If the claim preamble is "'necessary to give life, meaning, and
vitality"' to the claim, then the claim preamble should be construed as if in
the balance of the claim. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182
F.3d 1298, 1305 (Fed. Cir. 1999) (citing Kropa v. Robie, 187 F.2d 150, 152
(CCPA 1951)). In this case, we agree with Appellant that the preamble of
claim 1, namely, "[a] left atrial appendage occlusion device," "is no mere
4
Appeal 2016-007653
Application 11/245,421
statement of intended use," but rather, "defin[ es] the structure of the claimed
device." Reply Brief 2 ( filed Aug. 9, 2016, hereinafter "Reply Br."). In
other words, Appellant is correct in that the phrase "[a] left atrial appendage
occlusion device" defines a device "of a size and shape appropriate to
occlude the left atrial appendage." Id.
Here, Appellant's Specification describes the claimed "left atrial
appendage occlusion device" as a device intended to prevent formation and
migration of clots from the left atrial appendage into the bloodstream by
completely or substantially preventing blood flow into the appendage from
occurring. Spec. paras. 9, 25. According to the Specification, "[b ]lood
pooling in the appendage may arise spontaneously ... as a result of atrial
fibrillation" and "[ w ]hen blood pools in the appendage, blood clots form"
such that "[t]he migration of clots from the left atrial appendage to the
bloodstream can cause serious problems when they embolize in the arterial
system." Spec. para. 1.
A left atrial appendage (Figure 4) is illustrated below:
/(1,),n.._,.._._,
}('.,
~
i
\
( ~. '
'-~ ....
... ._ --··••·u~•··•···· • ....- ,,)
Appellant's Figure 4 illustrates a left atrial appendage 100 with an occlusion
device deployed therein.
5
Appeal 2016-007653
Application 11/245,421
In contrast to the irregularly shaped left atrial appendage illustrated
above, the defects of Baccaro and Shaw are "through-hole type defects ...
[that] extend[] entirely through a tissue wall" and "are narrow, cylindrical or
slightly conical openings," and, thus, "have a relatively simpl[e] shape."
Appeal Br. 8.
For example, an annotated portion of Baccaro's Figure 3 and Shaw's
Figure 40A, shown below, illustrates conical through-hole defects 4 and 254,
respectively:
FlG. 40A
Baccaro' s Figure 3 illustrates an occluding device "a" located within
through-wall defect 4 connecting vessel conduits band b' and Shaw's Figure
40A illustrates occlusion device 132 located within through-wall defect 254.
The Examiner does not adequately explain how the device of Baccaro,
as modified by Shaw, would be capable of occluding a left atrial appendage,
which is an irregularly shaped blind-hole, whereas each of the Baccaro and
Shaw devices occludes a completely different structure, namely, "through-
hole type defects" that have relatively simple shapes. The Examiner's
conclusory statement that "the device of Baccaro in view of Shaw ... is
capable of being used as claimed" is not enough to satisfy the Examiner's
obligation to provide a reasoned explanation for such a statement. Ans. 2.
In other words, just because Baccaro' s device "is adaptable to fit ... within
6
Appeal 2016-007653
Application 11/245,421
vascular regions of varying diameters" does not mean that it is capable of
occluding "[a] left atrial appendage" so that it prevents blood flow into the
appendage from occurring. See id. at 3 (emphasis added); claim 1. We
agree with Appellant that there is "no indication [ on record] that the
dimensions and shape" of the device of Baccaro, as modified by Shaw,
would allow its use as "[a] left atrial appendage occlusion device," as called
for by claim 1. Reply Br. 2.
Furthermore, we note that the Examiner's position that "the
thrombogenic coating of the device of Baccaro is completely optional" is
untenable as Baccaro explicitly discloses its device forming a thrombus (i.e.,
blood clot) on itself to occlude a through-opening defect. See Ans. 4; see
also Baccaro, col. 1, 11. 5-9 ("device for occluding abnormal vessel
communications ... [by] allowing the formation of a self-occluding
thrombus"). Accordingly, a person skilled in the art of cardiology would
readily understand that if the device of Baccaro, as modified by Shaw, is
positioned within the left atrial appendage, as the Examiner proposes, it
would tend to form blood clots.
As such, we agree with Appellant that in contrast to the "left atrial
appendage occlusion device" of claim 1, which "works by preventing
migration of clots from the left atrial appendage," Baccaro's device works
"by intentionally forming a clot on the device itself." Appeal Br. 9
( emphasis added). Therefore, it is doubtful whether Baccaro' s device, as
modified by Shaw, is suitable as "[a] left atrial appendage occlusion device,"
which constitutes a device intended to prevent formation and migration of
clots from the left atrial appendage into the bloodstream. The Examiner has
not offered any persuasive evidence or technical reasoning to support a
7
Appeal 2016-007653
Application 11/245,421
finding that a person of ordinary skill in the art of cardiology would have
recognized the device of Baccaro, as modified by Shaw, as "[a] left atrial
appendage occlusion device."
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 103(a) of claims 1, 5, 15, 23, 33, and 44 as
unpatentable over Baccaro and Shaw. 3
Rejections 11-V
The Examiner's use of the Van Tassel, Wallace, and Huebsch
disclosures does not remedy the deficiency of the Examiner's combination
ofBaccaro and Shaw discussed supra. See Final Act. 7-9. Therefore, for
the reasons noted above, we also do not sustain the rejections under
35 U.S.C. § 103(a) of claims 27, 29, 30, and 45--47.
SUMMARY
The Examiner's decision to reject claims 1, 5, 15, 23, 27, 29, 30, 33,
and 44--47 under 35 U.S.C. § 103 is reversed.
REVERSED
3 We do not need to reach the evidence submitted by Appellant in the
Declaration of Dr. Daniel S. Levi, filed under 37 C.F.R. § 1.132 on April 17,
2015.
8