ATRITECH, INC.

Patent Trials and Appeals Board

Jun 30, 2020

2020000358 (P.T.A.B. Jun. 30, 2020)

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.
15/333,945 10/25/2016 Erik J. van der Burg 1001.2706129 7657
11050 7590 06/30/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
BACHMAN, LINDSEY MICHELE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/30/2020 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 ERIK J. VAN DER BURG, DINO DE CICCO, ANDREW G.C.
FRAZIER, ALEXANDER K. KHAIRKHAHAN, MARC S. KREIDLER,
MICHAEL D. LESH, and CHAD C. ROUE
____________

Appeal 2020-000358
Application 15/333,945
Technology Center 3700
____________

Before BENJAMIN D. M. WOOD, WILLIAM A. CAPP, and
LISA M. GUIJT, Administrative Patent Judges.

GUIJT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the rejection
of claims 2–4 and 6–22. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” 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.
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THE INVENTION
Appellant’s invention relates to a “System for Left Atrial Appendage
Occlusion.” Spec., Title. Claim 1, reproduced below as the sole
independent claim on appeal, is illustrative of the subject matter on appeal.
1. A device configured for implantation in a left atrial
appendage, the device comprising:
a membrane support structure having a radially
compressed configuration and a radially expanded configuration,
wherein the membrane support structure has a distal end and
defines a proximal diameter in the radially expanded
configuration;
a membrane extending across at least part of a proximal
portion of the membrane support structure; and
one or more distal anchoring segments configured to
engage a wall of the left atrial appendage which one or more
distal anchoring segments extend distally from the distal end of
the membrane support structure in the radially expanded
configuration,
wherein in the radially expanded configuration the one or
more distal anchoring segments define a distal diameter which is
less than the proximal diameter of the membrane support
structure.

THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Simon US 5,669,933 Sept. 23, 1997
Daniel US 5,814,064 Sept. 29, 1998
Ambrisco US 6,007,557 Dec. 28, 1999
Brooks US 6,346,116 B1 Feb. 12, 2002
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The following rejections are before us for review:
I. Claims 2, 4, 6–9, and 15–22 stand rejected under 35
U.S.C. § 102(b) as anticipated by Simon.
II. Claim 3 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Simon.
III. Claims 10 and 14 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Simon and Ambrisco.
IV. Claims 11 and 12 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Simon and Daniel.
V. Claims 13 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Simon and Brooks.

OPINION
Rejection I
Appellant argues claims 2, 4, 6–9, and 15–22 as a group. Appeal
Br. 6–10. We select independent claim 2 as representative, and claims 4, 6–
9, and 15–22 stand or fall therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
Regarding independent claim 2, the Examiner finds that Simon
discloses a device (i.e., blood clot filter 10) comprising a membrane support
structure (i.e., filter basket section 16) having radially compressed and
radially expanded configurations, and also a distal end (i.e., “area between
elements 14 and 16”) and a proximal diameter in the radially expanded
configuration. Final Act. 4–5 (citing Simon 3:46–58, Figs. 1, 2). The
Examiner also finds that Simon discloses a membrane (i.e., flexible
mesh 30) extending across at least part of a proximal portion of the
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membrane support structure (i.e., filter basket section 16), and distal
anchoring segments (i.e., wires 18) configured to engage a wall of the left
atrial appendage and extending distally from the distal end of the membrane
support structure in the radially expanded configuration. Id. at 5 (citing
Simon, Figs. 1, 2, 4). The Examiner explains that Simon’s distal anchoring
segments (i.e., wires 18) are configured to engage a wall of the left atrial
appendage, as claimed, because “the anchoring segments extend outwardly
from the support structure.” Id. The Examiner further finds that Simon
discloses that, in the radially expanded configuration, the distal anchoring
segments (i.e., wires 18) define a distal diameter which is less than the
proximal diameter of the membrane support structure. Id. (citing, Simon,
Fig. 2). The Examiner determines that “[t]he terms ‘distal’ and ‘proximal’
are well known in the art to be relative terms to describe parts of the human
body, surgical tool and implants and do not impart a structural limitation.”2
Ans. 4.

2 The Examiner’s reliance on U.S. Pat. No. 4,425,908 is unnecessary to the
Examiner’s rejection of claim 2 as stated in the Final Office Action. Ans. 5–
6. Notwithstanding, we are not persuaded by Appellant’s argument that the
Examiner improperly relied on a new reference (i.e., U.S. Pat. 4,425,908)
without including the new reference in the statement of the rejection or
indicating that the new reference is a new ground of rejection. Reply Br. 2.
Simon expressly discloses use of the insertion tool disclosed in U.S. Pat.
4,425,908, such that Appellant is on notice regarding the subject matter of
U.S. Pat. 4,425,908 relative to Simon’s blood clot filter. Simon 6:46–48
(“[t]he filter may be positioned initially within a vessel by known delivery
devices such as the one shown in U.S. Pat. No. 4,425,908”). In addition,
allegations that an examiner’s answer contains undesignated new grounds of
rejection must be resolved by filing a petition to reopen prosecution under
37 C.F.R. § 1.181, the absence of which constitutes waiver of such
arguments. 37 C.F.R. §41.40 (“Failure of appellant to timely file such a
petition will constitute a waiver of any arguments that a rejection must be
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Appellant argues that the Examiner errs by assigning a distal-proximal
reference system inconsistent with the “ordinary and common meanings as
used by the art of medical devices” and also inconsistent with the “self-
consistent usage” of the terms proximal and distal in the Specification (with
particular reference to the Figures) and claims. Appeal Br. 7; Reply Br. 4–7.
In particular, Appellant submits that, with reference to Figure 4 of Simon,
the Examiner “erroneously identified [optional flexible mesh 30] as
corresponding to the membrane of instant claim 2,” which “is explicitly
attached to second filter basket section 16.” Appeal Br. 7. Appellant
submits that, conventionally, the claim term “distal” “refers to the portion of
the device distant from the point of reference” and the claim term
“proximal” “refers to the portion proximate the point of reference” (id. at 6),
and thus, a person of ordinary skill in the art would understand Simon’s
device, according to Appellant’s annotated Figure 7 of Simon below,
wherein “[the] second filter basket section 16 is distally remote from the
proximal operator’s handle” (id. at 8).

designated as a new ground of rejection.”); accord MPEP § 1207.03.
Appellant did not file a petition and, therefore, waived any argument that the
Examiner’s Answer includes new grounds of rejection.

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Appellant’s annotated Figure 7 of Simon depicts a removal tool for blood
clot filter 10 and includes Appellant’s arrows identifying proximal and distal
directions with respect to the removal tool, such that second filter basket
section 16 is distal from (or situated away from) the point of attachment to
the removal tool. Id. at 6; Simon 3:28–29, Fig. 7. Appellant submits that
“[o]ne of ordinary skill in the art of left atrial appendage occlusion devices
would have known that a transvenous approach to the left atrial appendage
would dictate the instantly indicated implantation approach direction in
which the distal end of the device enters the left atrial appendage first.”
Reply Br. 3.
We are not persuaded by Appellant’s argument. The Examiner is
correct in that claim 2 does not specify a structure for referencing the
proximal diameter or portion, and distal end of the membrane support
structure, which can be relied on to distinguish the claimed device from
Simon’s device, in view of the proximal and distal positions assigned by the
Examiner to Simon’s device. Thus, claim 2 reads on Simon’s blood clotting
device.
Appellant also argues that Figure 4 of Simon is the only figure
depicting mesh 30, which the Examiner “erroneously identified . . . as
corresponding to the membrane of instant claim 2.” Appeal Br. 7; see also
id. at 12 (“Simon does not teach a membrane but instead teaches an optional
mesh 30”). To the extent Appellant is arguing that Simon’s mesh does not
disclose a membrane, Appellant does not provide sufficient argument or
evidence as to why Simon’s mesh is not, structurally, also a membrane. To
the contrary, the prior art recognizes that mesh is considered a membrane:
“[m]esh 22 is preferably formed of woven or braided fibers or wires, or a
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microporous membrane, or other suitable filtering or netting-type material,”
and more particularly, “mesh 22 is a microporous membrane having holes
therein with a diameter of approximately 100 μm.” Daniel 3:33–37
(emphasis added).
Appellant also argues that
one of ordinary skill in the art would not view the temporary
venous filter of Simon, explicitly described as a removable
implant, as directed toward the same field of art as a left atrial
appendage implanted for reducing the risk of thrombus
formation in and release from a left atrial appendage through
occluding the atrial appendage opening, optionally through
tissue ingrowth.
Appeal Br. 9 (emphasis added). Appellant submits that
one of ordinary skill in the art would not have turned to . . .
venous filter references . . . disclosing designs which result in
substantially unimpeded axial flow of blood through the
respective lumens, for guidance in designing an occlusive
element for implantation in a left atrial appendage, especially
given the clearly different geometries of the implantation sites
for the two categories of devices, i.e., an open tubular vein vs, a
closed-end tapered left atrial appendage.
Reply Br. 2 (emphasis added).
To the extent Appellant is arguing that Simon is non-analogous and
therefore, improperly relied on by the Examiner, Appellant’s argument is
misplaced. The test to determine whether a reference is analogous is
relevant to an obviousness determination, but not to an anticipation
rejection. See Celeritas Techs., Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354,
1361 (Fed. Cir. 1998) (“[T]he question whether a reference ‘teaches away’
from the invention is inapplicable to an anticipation analysis.”); see also In
re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (“[T]he question whether
a reference is analogous art is irrelevant to whether that reference
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anticipates.”). Here, not only is the Examiner’s reliance on U.S. Pat.
4,425,908 unnecessary (and alternatively, only evidentiary), but the
Examiner is not proposing any modification to Simon’s blood clot filter in
view of any prior art, but states a prima facie case that claim 2 is anticipated
by Simon pursuant to 35 U.S.C. § 102(a)(1).
Appellant further argues that Simon fails to disclose that Simon’s
anchoring segments are configured to engage a wall of the left atrial
appendage, as required by claim 2. Appeal Br. 9. Appellant submits that
this claim recitation is not “merely intended use, . . . but rather imparts
meaningful limitations upon the structure of the device, which limitations
are related to the dimensions and structure of an expressly recited left atrial
appendage.” Id. Appellant submits that
one of ordinary skill in the art would be aware that a generally
cylindrical venous filter of uniform diameter along its length,
which could be appropriate for deployment within a tubular vein
would not necessarily be adapted to engage and be retained
within a left atrial appendage. For example, were the overall
cylindrical filter of Figs. 1 and 2 of Simon to be sized to have an
expanded diameter appropriate to engaging the wall of a left
atrial appendage deep within the left atrial appendage while
maintaining the length to diameter ratio indicated by the various
figures of Simon, the distal basket 14 would not be expected to
have a diameter large enough to span the ostium of the left atrial
appendage at the device’s proximal end. One of ordinary skill in
the art would be well aware that this mismatch between the
geometry of a vein and the left atrial appendage and would be
aware that a venous filter of Simon when inserted into a left atrial
appendage would be unsuited for filtering blood flow into and
out of the left atrial appendage or for the instant purpose of
occluding the flow of debris out of the left atrial appendage as
taught by the instant invention.
Reply Br. 8–9.
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We are not persuaded by Appellant’s argument. The Specification
discloses that “[f]or patients who develop atrial thrombus from atrial
fibrillation, the clot normally occurs in the left atrial appendage (LAA) of
the heart,” wherein “[t]he LAA is a cavity which looks like a small finger or
windsock and which is connected to the lateral wall of the left atrium.”
Spec. 1:25–27. The Specification also discloses that
FIG. 4 depicts an occluding device 30 similar to that depicted in
FIGS. 1-3 deployed within the left atrial appendage 31 of a
patient. An outer rim or periphery 32 of the occluding device 30
is disposed adjacent the opening 33 of the left atrial appendage
31 in a position which allows for a substantial seal of the outer
rim against the inside surface 34 of the LAA. A helically shaped
distal extremity 35 of a tissue penetrating shaft 36 has been
screwed into the wall tissue of the LAA and is mechanically
secured thereto. A retention member 38 maintains the position
of an occluding member 41 in a substantially perpendicular
orientation with respect to a longitudinal axis of the LAA 42.
Spec. 11:24–31. Figure 4 is reproduced below.

Figure 4 depicts “an elevational view of an apparatus having features of the
invention in a deployed state within a body cavity.” Spec. 5:26–27.
In comparison, Simon discloses, with reference to Figure 2
reproduced below (rotated to correspond to the orientation of the device
depicted in Figure 4 supra), that “two filter sections provide peripheral
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portions which engage the inner wall of the vein at two longitudinal spaced
locations.” Simon 3:63–65.

Figure 2 of Simon depicts a filter “in place within a vessel.” Id. at 3:17–18.
Simon discloses that “first filter basket section 14 is formed from short,
arcuate lengths of wire 18 which form arms that curve downwardly,
outwardly and upwardly from the hub 12 toward the trailing end of the filter
10,” wherein “tip sections 20 of the wires 18 are substantially straight
lengths with ends which lie on a circle at their maximum divergence and the
tip sections engage the wall 22 of a vessel at a slight angle 23 . . . to anchor
the filter 10 against upward movement.” Id. 4:1–8. Although Simon is
silent with respect to placement of Simon’s device within a left atrial
appendage, which has a closed end, as compared to an open-ended vein,
Appellant does not provide sufficient argument or evidence as to why
Simon’s wires 18 are not also configured to engage a wall of the left atrial
appendage. In other words, Appellant does not identify any structure
relative to Simon’s wires 18 which distinguish Simon’s wires 18 from the
distal anchoring segments disclosed in the Specification, or which would
cause wires 18 not to engage a wall of the left atrial appendage.
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Accordingly, we sustain the Examiner’s rejection of independent
claim 2, and claims 4, 6–9, and 15–22 fall therewith.
Rejection II
Claim 3, which depends from independent claim 2, recites, in relevant
part, “wherein the one or more distal anchoring segments extend radially
outward in a proximal direction in the radially expanded configuration.”
Appeal Br. 15 (Claims App.). The Examiner finds that Simon teaches “an
alternate embodiment,” with reference to Figures 5 and 6, wherein a distal
anchoring segment (i.e., first filter basket 40) extends radially outwardly in a
proximal direction in an expanded configuration, as claimed. Final Act. 7.
The Examiner reasons that it would have been obvious to have used such a
“known technique” and that positioning the segments as claimed would have
been within “the ordinary capabilities of one skilled in the art.” Final
Act. 7–8.
Appellant argues that, similar to claim 2 supra, wire segments 16, 18,
with particular reference to Figures 5 and 6, “as a whole extend distally
radially outward when viewed relative to the directional convention of the
instant specification and claims.” Appeal Br. 10–11. Appellant also argues
that “there is no articulated motivation to modify the apparently fully
functional filters of Simon by a proximal-to-distal inversion, as articulated
by the Examiner, with a reasonable expectation of success for the purpose of
Simon.” Id. at 11.
We are not persuaded by Appellants argument, in that we do not agree
that the Examiner erred by assigning the proximal-distal reference system as
set forth in the Examiner’s rejection and as discussed supra with respect to
independent claim 2. Further, we find that wires 18, as depicted in
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Figures 4, and wires arms 38, as depicted in Figures 5 and 6, have portions
that extend radially outwardly in a proximal direction, as claimed, as well as
portions that extend radially outwardly in a distal direction, such that claim 3
reads on Simon’s wires 18. Regarding Appellant’s argument addressing the
Examiner’s lack of “articulated motivation,” we disagree that the Examiner
failed to provide reasoning, to the extent Simon’s Figure 4 embodiment
requires modification, in that the Examiner reasons, in sum, that the
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results. See KSR Int'l
Co. v. Tele-flex Inc., 550 U.S. 398, 416 (2007).
Accordingly, we sustain the Examiner’s rejection of claim 3.
Rejection III
Claims 10 and 14, which depend from independent claim 2, recite, in
relevant part, “wherein the membrane is a barrier membrane” and “wherein
the membrane is formed as a composite laminate,” respectively. Appeal
Br. 16 (Claim App.). The Examiner finds that Simon discloses a membrane,
but not a barrier membrane or a membrane formed as a composite laminate,
and the Examiner relies on Ambrisco for teaching that “the filtering material
can be in the form of a . . . barrier membrane (because it resists tissue
ingrowth) or a laminate (because it is disclosed as being layered).” Final act.
7–8 (citing Ambrisco 3:10–30). The Examiner reasons that it would have
been obvious to modify Simon’s membrane, as taught in Ambrisco, because
“the particular known technique of composite filter membranes and drug-
coated filter membranes was recognized as part of the ordinary capabilities
of one skilled in the art.” Final Act. 8.
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Appellant argues that “Simon does not teach a membrane and instead
teaches an optional mesh 30,” and further, that Ambrisco does not teach “a
composite laminate” or “a barrier membrane.” Appeal Br. 11 (citing
Ambrisco 3:10–30).
As discussed supra Simon discloses a mesh, which the prior art
considers a membrane, and also that “mesh 30 will permit blood to pass
through the section 16 but will capture bone chips and small particles which
might otherwise pass between the wires 24 and 18.” Simon 4:16–5:5
(emphasis added). Thus, Simon discloses a membrane that serves as a
barrier to bone chips and small particles, and we are not apprised by
Appellant as to why Simon’s membrane does not qualify as a barrier
membrane. Notwithstanding, the Examiner relies on Ambrisco, which
discloses that “filter mesh pore sizes ideally range[] from 40 to 120 microns,
but other sizes may be used,” suggesting that the mesh may be selected to
block the passage of certain material, the characteristic ascribed to barrier 15
by the Specification. Ambrisco 3:13–14; see also id. at 20:28–30
(“[o]cclusion techniques include reducing the mesh pore size, and thereby
the permeability of the mesh”). In sum, we are not apprised of error in the
Examiner’s finding that claim 10 is obvious in view of Simon and Ambrisco.
Regarding claim 14, the Specification also discloses that “bonding
layer 254 preferably comprises a mesh or other porous structure having an
open surface area,” which is “positioned in-between a first membrane 250
and a second membrane 252 to provide a composite stack.” Id. 20:27–
21:12. In other words, we are not apprised of error in the Examiner’s
finding that the claim term “composite” means layered. Ambrisco discloses
that “[t]he mesh,” which as discussed supra is considered a membrane in the
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prior art, may be “layered,” and thus, Appellant’s recitation of the claim
language does not apprise us of error in the Examiner’s finding or reasoning.
Notably, statements that merely point out what a claim recites are not
considered to present an argument for separate patentability of the claim. 37
C.F.R. § 41.37(c)(1)(iv); see also In re Lovin, 652 F.3d 1349, 1357 (Fed.
Cir. 2011) (Rule 41.37 requires more than recitation of the claim elements
and a naked assertion that the elements are not found in the prior art).
Accordingly, we sustain the Examiner’s rejection of claims 10 and 14.
Rejection IV
Claims 11 and 12, which depend from independent claim 2, recite, in
relevant part, “wherein the membrane is a porous membrane” and “wherein
the membrane includes opening or pores within a range of from about
0.0005 inches to about 0.010 inches,” respectively. Appeal Br. 16 (Claim
App.). The Examiner finds that Daniel discloses a porous membrane
(i.e., 22) with openings in the claimed range, because “this allows blood to
flow through but retains stenosis fragments carried in the blood flow.” Final
Act. 9. The Examiner reasons that it would have been obvious to have
modified Simon’s filter, as taught by Daniel, to allow blood to flow through
the filter, but to retain stenosis fragments carried in the blood flow. Id.
Appellant argues that “Simon does not teach a membrane and instead
teaches an optional mesh 30,” which as discussed supra, we do not find
persuasive. Appellant also argues that “there is no motivation to combine
the teaching of Simon and Daniel.” Appeal Br. 12. Appellant submits that
“the presence of a membrane of unspecified fractional openness in a venous
filter would be expected to undesirably occlude a vessel in which it might be
deployed, such as a vena cava, thereby rendering the device unsatisfactory
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for its intended purpose.” Id. However, Appellant does not provide
sufficient argument or evidence that modifying the pores sizes of Simon’s
mesh 30, as taught in Daniel, would cause Simon’s mesh to function
unsatisfactorily as a blood clot filter.
Accordingly, we sustain the Examiner’s rejection of claims 11 and 12.
Rejection V
Claim 13, which depends from independent claim 2, recites, in
relevant part, “wherein the membrane is formed from materials which
facilitate cellular in-growth.” Appeal Br. 16 (Claims App.). The Examiner
relies on Brooks for teaching a filter membrane made of ePTFE, which is a
material disclosed in the Specification as resisting tissue in-growth.3 Final
Act. 9 (citing Brooks 3:62–64, 4:3–6; Spec. 20:15–20). The Examiner
reasons that it would have been obvious to make Simon’s filter from ePTFE,
as taught by Brooks, because “the particular known technique of using
ePTFE as a filter membrane was recognized as part of the ordinary
capabilities of one skilled in the art.” Id.
Appellant argues that the Examiner improperly relied on Appellant’s
Specification and mischaracterized Appellant’s Specification “as disclosing
that ePTFE resists tissue ingrowth.” Appeal Br. 13. In particular, Appellant
submits that the Specification discloses that “barrier 15 may comprise any of
a variety of materials which facilitate cellular in-growth, such as ePTFE.”
Appeal Br. 13.

3 The Examiner states that, in the Final Rejection, the Examiner meant to
find that that ePTFE is a material disclosed in the Specification for
facilitating, not resisting, tissue in-growth. Ans. 10 (“should say
‘facilitate’”).
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We are not persuaded by Appellant’s argument. Indeed, Brooks
discloses that “suitable filter materials may include . . . ePTFE . . . and the
like having an appropriate porous construction to filter emboli from blood
passing through the filter” (Brooks 4:3–6), and the Specification discloses
that “barrier 15 may comprise any of a variety of materials which facilitate
cellular in-growth such as ePTFE” (Spec. 20:16–17). The Examiner may
properly rely on the Specification for disclosing that it is known that ePTFE
is one of a variety of materials recognized for facilitating cellular in-growth.
Accordingly, we sustain the Examiner’s rejection of claim 13.

CONCLUSION
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s) Affirmed Reversed
2, 4, 6–9,
15–22
102(b) Simon 2, 4, 6–9,
15–22

3 103(a) Simon 3
10, 14 103(a) Simon and Ambrisco 10, 14
11, 12 103(a) Simon and Daniel 11, 12
13 103(a) Simon and Brooks 13
Overall
Outcome
2–4, 6–22
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED