BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Jun 25, 2021

2020006606 (P.T.A.B. Jun. 25, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/493,736 04/21/2017 Brian Joseph Tischler 1001.3049102 8362
11050 7590 06/25/2021
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
LAUER, CHRISTINA C
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/25/2021 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BRIAN JOSEPH TISCHLER et al.

Appeal 2020-006606
Application 15/493,736
Technology Center 3700
____________

Before JOHN C. KERINS, BENJAMIN D. M. WOOD, and
MICHAEL L. WOODS, Administrative Patent Judges.

KERINS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision to reject claims 2–16 and 21–25.1 We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 The term “Appellant” is used herein to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Boston Scientific Scimed, Inc., as the
real party in interest. Appeal Br. 4.
Appeal 2020-006606
Application 15/493,736

2
THE CLAIMED SUBJECT MATTER
Appellant’s invention relates to a left atrial appendage closure
implant. Claims 2 and 11 are illustrative, and are reproduced below:
2. A medical device for left atrial appendage closure,
comprising:

a rotatable seal runner;

a delivery catheter having a lumen extending therethrough;
and

a left atrial appendage closure implant comprising:

a proximal collar;

a distal collar,

the proximal collar and the distal collar together
defining a longitudinal axis; and

a monolithic support frame formed of a plurality of
struts, the plurality of struts defining an interior
volume of the left atrial appendage closure implant
and including proximal strut ends and distal strut
ends,
wherein the proximal strut ends of the monolithic
support frame are fixedly attached to the proximal
collar and initially extend distally from the proximal
collar,

wherein the distal strut ends of the monolithic support frame
are fixedly attached to the distal collar and initially extend
distally from the distal collar,

wherein the proximal collar is located outside the interior
volume of the left atrial appendage closure implant and the
Appeal 2020-006606
Application 15/493,736

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distal collar is located within the interior volume of the left
atrial appendage closure implant, and

wherein the struts of the plurality of struts of the monolithic
support frame include, when unconstrained, in proximal-to-
distal sequence first, concave outward, bends formed from
the proximal strut ends extending from the proximal collar
to second, convex outward, bends, first segments extending
from the second, convex outward, bends to third convex
outward, bends, second segments extending from third,
convex outward, bends to fourth, convex outward, bends,
and extending from the fourth, convex outward, bends to the
distal collar, wherein the struts of the plurality of struts have
no other intervening bends,

wherein the monolithic support frame is actuatable from a
first constrained configuration to a second flowering
configuration to a third mid-deployment configuration to a
fourth unconstrained configuration.

11. A left atrial appendage closure implant, comprising:

a self-expanding support frame, having a circumference, a
central longitudinal axis, a proximal collar, and a distal
collar, the self-expanding support frame extending between
the proximal collar and the distal collar and comprising
struts which each include:

a first, outwardly concave, bend which extends
distally and radially outward from a point of fixed
attachment to the proximal collar in a C-shaped bend
from the proximal collar to a second, outwardly
convex, C-shaped bend;

a first segment which extends distally and radially
inward from the second, outwardly convex, C-shaped
bend to a third, outwardly convex, bend;

Appeal 2020-006606
Application 15/493,736

4
a second segment which extends radially inward and
distally from the third, outwardly convex, bend to a
fourth, outwardly convex, bend; and

a distal strut end which extends from the fourth,
outwardly convex, bend proximally and radially
inward to be fixedly attached to the distal collar;
wherein the struts are devoid of outwardly concave
bends between the first, outwardly concave, bend and
the fourth, outwardly convex, bend;

a membrane disposed over at least a portion of the self-
expanding support frame; and

a plurality of anchors arranged into a first row and a second
row such that the first row and the second row together form
a staggered pattern about the circumference of the self-
expanding support frame between second, convex outward,
bends and third, convex outward, bends.

THE REJECTIONS
The Examiner rejects:
(i) claims 2–8, 10–13, and 21–25 under 35 U.S.C. § 103(a) as being
unpatentable over Mazzocchi (US 2001/0000797 A1, published May 3,
2001) in view of Berrada (US 2005/0283186 A1, published Dec. 22, 2005)
and Khairkhahan (US 2002/0111647 A1, published Aug. 15, 2002); and
(ii) claims 9 and 14–16 under 35 U.S.C. § 103(a) as being
unpatentable over Mazzocchi in view of Berrada, Khairkhahan, and Sutton
(US 9,883,936 B2, issued Feb. 6, 2018).
Appeal 2020-006606
Application 15/493,736

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ANALYSIS
Claims 2–8, 10–13, and 21–25--§ 103--Mazzocchi/Berrada/Khairkhahan
The Examiner finds that Mazzocchi discloses a medical device
capable of and sized for being placed within a left atrial appendage for
closure comprising a closure implant with a proximal collar (74 and anchor
portion 70), a distal collar (15) along a longitudinal axis (Figs. 5B and 6), a
self-expanding support frame (80) that defines an interior volume, the
support frame including struts that, in proximal-to-distal sequence include a
first concave outward or C-shaped bend formed from proximal strut ends
extending from the proximal collar to a second, convex outward or C-shaped
bend, first segments extending from the second, convex outward bend to a
third convex outward bend, second segments extending from the third
convex outward or C-shaped bend to a fourth convex outward bend, and
extending from the fourth convex outward bend to the distal collar. Final
Act. 3–4. An Examiner-annotated version of Figure 5B of Mazzocchi
appears below, identifying which portions correspond to the claim elements,
Appeal 2020-006606
Application 15/493,736

6
and the figure having been further modified by the Examiner by adding a
rectangle around the area considered to be the proximal collar.

Depicted above is an Examiner-annotated version of Figure 5B of
Mazzocchi, which is a schematic side cross section view of an aneurysm
occlusion device. Mazzocchi ¶ 22.
Appellant argues that, because the clamps (15, 74, Figure 5B) of
Mazzocchi are consistently described as being attached to proximal and
distal ends of the metal fabric, to interpret the proximal collar as including a
portion of the metal fabric, namely anchor portion (70) thereof, improperly
construes a portion of the metal fabric as being part of the proximal collar
recited in claim 2. Appeal Br. 9.
The Examiner responds that the proximal collar is defined by the
shape of the occluding device, and that the claim language does not require
that the wires or struts cannot be part of the clamp. Ans. 3. The Examiner
therefore takes the position that, with the anchor portion 70 being part of the
claimed proximal collar, Mazzocchi discloses the claimed sequence of bends
Appeal 2020-006606
Application 15/493,736

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as shown in the above Examiner-annotated version of Figure 5B thereof. Id.
at 3–4.
The Examiner misunderstands the disclosure of Mazzocchi as applied
to the claims. The wires of Mazzocchi are struts which make up the support
frame. The claim language requires that the struts of the support frame
extend from the proximal collar to the distal collar. As such, we believe the
Examiner has applied an unreasonably broad interpretation to claim 2 in
finding a portion of the support frame to instead be part of the proximal
collar. As the claims also require that the sequence of bends extend from
proximal to distal with no other intervening bends, Mazzocchi cannot
disclose this sequence if only element 74 is considered the distal collar. This
is because Mazzocchi discloses other bends between element 74 and the first
concave outward bend identified by the Examiner.
As we find that the inclusion of the portion of Mazzocchi’s struts as
indicated by the Examiner as being a portion of the claimed proximal collar
is unreasonable, the Examiner’s finding that the Mazzocchi discloses the
claimed proximal and distal collar, support frame comprising struts, with the
sequence of bends having no other intervening bends, is not supported in the
record. Accordingly, the rejection of 2–8, 10–13, and 21–25 as being
unpatentable over Mazzocchi, Berrada, and Khairkhahan is not sustained.

Claims 9 and 14–16 --§ 103--Mazzocchi/Berrada/Khairkhahan/Sutton
Appellant argues that Sutton does not cure the alleged deficiencies in
Mazzocchi, Berrada, and Khairkhahan. Appeal Br. 18–19. In that we find
Mazzocchi, Berrada, and Khairkhahan deficient as applied by the Examiner,
for the reasons presented above, these rejections are not sustained.
Appeal 2020-006606
Application 15/493,736

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CONCLUSION
The rejection of claims 2–8, 10–13, and 21–25 under 35 U.S.C.
§ 103(a) as being unpatentable over Mazzocchi, Berrada, and Khairkhahan
is reversed.
The rejection of claims 9 and 14–16 under 35 U.S.C. § 103(a) as
being unpatentable over Mazzocchi, Berrada, Khairkhahan, and Sutton is
reversed.

DECISION SUMMARY
In summary:

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
2–8, 10–
13, 21–25
103(a) Mazzocchi, Berrada,
Khairkhahan
2–8, 10–
13, 21–25
9, 14–16 103(a) Mazzocchi, Berrada,
Khairkhahan, Sutton
9, 14–16
Overall
Outcome
2–16, 21–
25

REVERSED