Dennis A. Peiffer et al.

Patent Trials and Appeals Board

Feb 10, 2020

13939383 - (D) (P.T.A.B. Feb. 10, 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.
13/939,383 07/11/2013 Dennis A. Peiffer 2001.1495101 7362
11050 7590 02/10/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
HIGHLAND, RACHEL S
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
02/10/2020 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 DENNIS A. PEIFFER, BRIAN JOSEPH TISCHLER,
TIMOTHY J. LEY, CHRISTOPHER J. CLARK, and THYNA M. CHAU
____________

Appeal 2019-000334
Application 13/939,383
Technology Center 3700
____________

Before MICHAEL L. HOELTER, MICHAEL J. FITZPATRICK, and
MICHELLE R. OSINSKI, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1–5, 7–16, 18, and 19.2 We have jurisdiction over
the appeal under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Br. 3.
2 Claims 6 and 17 are cancelled, and claim 20 is withdrawn. Appeal Br. 20–
21 (Claims App.); Final Act. 1.
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THE CLAIMED SUBJECT MATTER
Claims 1, 19, and 20 are independent. Claim 1 is reproduced below.
1. An occlusion device for an atrial appendage, the device
having proximal and distal ends and a central axis and
comprising a cage-like structure formed of struts, the struts
having proximal strut ends and distal strut ends,
wherein at the proximal end of the device the struts extend
towards the central axis and are connected to each other at their
proximal strut ends, and
wherein at least some of the struts are connected to each
other at their distal strut ends within the cage-like structure so
that the struts form an atraumatic distal end of the device such
that the distal ends of the struts point in a direction towards the
proximal end of the cage-like structure,
further wherein the cage-like structure has a proximal
section defining a first maximum diameter, a distal section
defining a second maximum diameter less than the first
maximum diameter, and an intermediate section between the
proximal section and the distal section which tapers from the first
maximum diameter to the second maximum diameter,
the occlusion device further comprising a filter membrane
affixed at the proximal end of the device.

EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Cox US 2011/0022149 A1 Jan. 27, 2011
Ferrera US 2011/0319917 A1 Dec. 29, 2011

REJECTIONS
I. Claims 1–5, 7–14, 16, 18, and 19 stand rejected under 35 U.S.C. § 103
as unpatentable over Cox. Final Act. 3–11.
II. Claim 15 stands rejected under 35 U.S.C. § 103 as unpatentable over
Cox and Ferrera. Id. at 11–12.
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OPINION
Rejection I
Appellant presents arguments for independent claims 1 and 19
together (Appeal Br. 8–17) and relies on the same arguments for dependent
claims 2–5, 7–14, 16, and 18 (id. at 17). We select claim 1 as representative
of the issues that Appellant presents in the appeal, and claims 2–5, 7–14, 16,
18, and 19 stand or fall therewith. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Cox teaches, among other things, “an
occlusion device . . . having a proximal end (near reference number 504 in
Fig. 51) and a distal end (near reference number 506 in Fig. 43).” Final
Act. 4. A first Examiner-annotated version of Cox’s Figure 51 (“First
Annotated Figure 51”) is reproduced below.

First Annotated Figure 51
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Figure 51 of Cox depicts an elevation view of a laser cut tube that is heat set
with first and second ends of the tube axially collapsed towards each other
into an everted globe like structure for a device for treatment of a patient’s
vasculature. Cox ¶¶ 70, 72. The First Annotated Figure 51 includes boxes
showing the Examiner-identified “proximal section” and “distal section” of
the device.
The Examiner also finds that Cox teaches the device “comprising a
cage-like structure.” Final Act. 4. In particular, the Examiner finds that “the
cage-like structure is deemed to be defined by the outermost sections of the
struts as marked by the dashed line in [second] annotated Fig. 51.” Id. This
second Examiner-annotated version of Cox’s Figure 51 (“Second Annotated
Figure 51”) is reproduced below.

Second Annotated Figure 51
The Second Annotated Figure 51 includes dotted lines and an
annotation stating “outermost sections of cage defined by struts (between
dotted lines).” Final Act. 3. The Second Annotated Figure 51 also includes
arrows pointing to first and second hubs/rings 514, 516 and indicates via
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annotation that they are both “inside cage formed by struts.” Id. That is, the
Examiner finds that “at least some of the struts are connected to each other
at their distal strut ends (at 514) within the cage-like structure.” Id. at 4.
The Examiner also finds that Cox teaches
struts (512) . . . having . . . distal strut ends (connected at 514 in
Fig. 51) . . . such that the distal ends (the distal ends are deemed
to be the s-shaped portions as circled in [first] annotated Fig. 51
. . . ) of the struts point in a direction toward the proximal end
of the cage-like structure.
Id. at 4. The Examiner takes the position that Cox “show[s] at least a
portion of the distal ends of the struts pointing towards the proximal end”
and “the claim as presently presented only requires a portion of the distal
end of the struts to point in the proximal direction.” Id. at 4–5. The
Examiner asserts that Appellant “has not defined any particular cut off point
which defines the distal end, nor has [Appellant] required the entirety of the
distal end to be pointing in the proximal direction.” Id. at 5. The First
Annotated Figure 51 includes “small arrows which show at least a portion of
the distal ends of the struts pointing towards the proximal end” according to
the position taken by the Examiner. Final Act. 4–5.
As to the occlusion device being “for an atrial appendage,” the
Examiner takes the position that “this is a recitation of intended use” and
“[a] recitation of intended use of the claimed invention must result in a
structural difference between the claimed invention and the prior art in order
to patentably distinguish the claimed invention from the prior art.” Id. at 4.
The Examiner also takes the position that “[i]f the prior art structure is
capable of performing the intended use, then it meets the claim” and “[i]n
the instant case, the structure of Cox is capable of being placed in any
vascular abnormality including an atrial appendage.” Id.
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As to “a filter membrane affixed at the proximal end of the device” as
claimed, the Examiner finds that Cox teaches a filter membrane at what the
Examiner has identified as the distal end of the device. Id. at 5 (citing Cox
Fig. 43). The Examiner finds that other embodiments of Cox teach a filter
membrane at what the Examiner has identified as the proximal end of the
device. Id. (citing Cox Figs. 20, 25–27). The Examiner concludes that it
would have been obvious to place the filter on either end of the device as is
known in the art as evidenced by Cox itself and which is a mere
rearrangement of parts and/or reversal of the essential working parts of a
device. Id. (citing In re Japikse, 181 F.2d 1019 (CCPA 1954) and In re
Einstein, 46 F.2d 373 (CCPA 1931)). The Examiner further finds that “Cox
teaches having the filter located at either end of the device depending upon
where the device is to be placed in the body” and concludes it would have
been obvious “to have the filter membrane be located at whatever portion of
the device was best so as to optimize the device to accommodate variations
in patient anatomy so as to better treat the particular location where the
device will be deployed.” Id. at 6.
Appellant first argues that:
Cox teaches that the end of the device of Figs. 43 or 51 near
first ring or hub 514 [and having the smaller diameter] is a
proximal end and, correspondingly the end of the device near
second ring or hub 516 [and having the larger diameter] [is] to
be considered the distal end of the device 500.
Appeal Br. 10. Appellant asserts that “this clear error in the identification of
the elements of Cox has led the Examiner to annotate Fig. 51 of Cox as
having an enlarged proximal end and a smaller distal end which is the
reverse of the teaching of Cox.” Reply Br. 3. Appellant supports its
argument with reference to Cox’s delivery system for device 500, in which
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the delivery system includes actuator 112 and a release mechanism 114
disposed on the distal end of actuator 112, such that end 508 of device 500
in contact with release mechanism 114 must be the proximal end. Appeal
Br. 9–10 (citing Cox Fig. 44, ¶ 143); see also Cox ¶ 210 (stating that
“release mechanism 114 . . . releasably secures a distal end of the actuator
member 112 to the device 500” and “detachment mechanism 114, or portion
thereof, may be secured within the lumen of the first ring 514”) and Cox
¶ 73 (stating that “FIG. 52 [which includes a portion of ring/hub 514] is an
enlarged view of a proximal portion of a strut element of the heat set support
structure of FIG. 51”).
Appellant’s Specification states that “the term ‘proximal’ refers to
those parts of the device which, when following a delivery catheter or
delivery instrument during regular percutaneous delivery, are closer to an
end of the catheter or instrument that is configured for manipulation by the
user.” Spec. 6:4–6. The Specification further states that “the term ‘distal’ is
used to refer to those parts of the device that are more distant from the end
of the catheter or instrument that is configured for manipulation by the user
and/or that are inserted further into the body of a patient.” Id. at 6:7–9.
We agree with Appellant that in accordance with how Cox discloses
delivery of device 500 (see, e.g., Cox Fig. 44), the end with ring/hub 514 is
the proximal end and the end with ring/hub 516 is the distal end. The
Examiner, however, responds that (i) “the claims are directed only to ‘an
occlusion device,’” (ii) “Appellant has not claimed a delivery device,” and
(iii) “[t]he Cox reference teaches all of the structures in the relative
orientation as claimed.” Ans. 3. We find the Examiner to have the better
position. That a certain end of the claimed occlusion device is deemed a
proximal end and that an opposing end is deemed a distal end does not
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impose any structural limitations on the occlusion device itself as claimed,
but rather simply reflects how the occlusion device would be oriented
relative to a delivery instrument when placed within a human body—i.e., is a
recitation with respect to the manner in which the claimed occlusion device
is intended to be employed. The particular manner in which a device or
article is intended to be employed, however, cannot be relied on to
distinguish structure from the prior art. See, e.g., In re Schreiber, 128 F.3d
1473, 1477 (Fed. Cir. 1997).
With respect to the structure of the proximal and distal ends, the claim
recites that the proximal section defines a first maximum diameter, the distal
second defines a second maximum diameter less than the first maximum
diameter, and there is an intermediate section between the proximal and
distal sections that tapers from the first maximum diameter to the second
maximum diameter. Appeal Br. 19 (Claims App.). The Examiner has
shown how Cox’s occlusion device meets these structural limitations. The
Examiner also found that Cox’s occlusion device is capable of being
oriented during delivery with the larger diameter end being closer to the
delivery instrument and the smaller diameter end being more distant from
the delivery instrument. See Ans. 3 (the Examiner stating that “[t]here are
no structures in the device of Cox which would prevent the device from
being deployed with the larger diameter end at the proximal side of the
device (closest to the surgeon) and the smaller diameter end at the distal
side”). Appellant has not rebutted this finding. Whether Cox’s occlusion
device actually is employed in such a manner is immaterial to whether Cox’s
occlusion device is capable of being so employed. A device of the prior art
meets a functionally-defined limitation if it is capable of the recited function,
and the prior art reference need not envision the device actually being used
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to perform the claimed function. See Schreiber, 128 F.3d at 1477. Any
difference between the claimed occlusion device and Cox’s occlusion device
is in its use, not its structure. Thus, we are not persuaded of error in the
Examiner’s finding that Cox teaches an occlusion device with a proximal
section defining a first maximum diameter, a distal section defining a second
maximum diameter less than the first maximum diameter, and an
intermediate section between the proximal section and the distal section
which tapers from the first maximum diameter to the second maximum
diameter, as claimed.
Appellant next argues that Cox fails to teach “at least some of the
struts are connected to each other at their distal strut ends within the cage-
like structure,” as claimed. Appeal Br. 10. In particular, Appellant argues
that even if the distal strut ends may be “within the outer periphery of the
cage,” this is not equivalent to the claimed limitation. Id. Appellant argues
that “neither first ring or hub 514 nor second ring or hub 516 is disclosed as
residing ‘within’ the cage-like structure,” but rather “rings or hubs 514, 516
of Cox are located external to the cage-like structure and within proximal
and distal dimples which are conditioned to form as the device is released
from a delivery system.” Id. In other words, Appellant argues that rings or
hubs 514, 516 are “outside of the volume defined by the struts 512 in
Fig. 51” and instead are “within the volume external to the cage-like
structure defined by the struts 512 in Fig. 51.” Id. at 11–12. Appellant
further argues that the Examiner “errs in attempting to substitute an
unsupported definition of ‘within’ amounting to ‘between the extreme
longitudinal extents of the deployed device’ for ‘within the volume defined
by the cage structure,’ where ‘within’ (adv.) is used in the sense of ‘in or
into the interior : inside.” Id. at 12. Appellant additionally argues that “one
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of ordinary skill in the art would understand the latter definition to be more
in keeping with the instant specification and figures.” Id.
The Examiner does not disagree with Appellant’s proffered definition
of “within” as meaning “in or into the interior: inside.” Ans. 4. But the
Examiner responds that in order to understand what is “in or into the
interior: inside” of the cage-like structure, “the outer boundary of the ‘cage-
like structure’ must be known.” Id. The Examiner asserts that in the
absence of any explanation in the claims of what is the outer boundary of the
cage-like structure, apart from indicating that it is “formed of struts with
proximal and distal ends,” “all the space that is contained within the outer
peripheries of the struts is deemed to be ‘within’ the cage-like structure.” Id.
at 4–5.
We agree with the Examiner that in the absence of further limiting
language in the claim, or of a clear indication in the Specification that
“within” specifically refers to being within a “volume” of the cage-like
structure, the Examiner’s position in which the Examiner shows how
rings/hubs 514, 516 of Cox are within or inside of an outer periphery of the
cage-like structure is sufficient to show that Cox teaches “struts . . .
connected to each other at their distal strut ends within the cage-like
structure,” as claimed.
Appellant next argues that Cox fails to teach that “the distal ends of
the struts point in a direction towards the proximal end of the cage-like
structure” as recited in claim 1 in that the distal ends point in a distal
direction. Appeal Br. 13, 14 (underlining omitted). Appellant’s argument
does not respond with sufficient particularity to the position taken by the
Examiner in the Final Action in which the Examiner is specifically pointing
to portions of the s-shaped portions of the struts as identified in the First
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Annotated Figure 51 to meet the claim limitations. Accordingly, we do not
find this argument persuasive of error.
Appellant next argues that “Cox does not . . . teach an occlusion
device for an atrial appendage and does not mention an atrial appendage.”
Appeal Br. 14. Appellant further argues that “[w]hile a suitably
dimensioned device of Fig. 43 of Cox may physically be positioned within
an atrial appendage, if so positioned it would no longer work for its intended
purpose of providing an intrasaccular device for treatment of a berry type
aneurysm.” Id. at 15. In addition, Appellant argues that:
[t]he Examiner’s proposed positioning of the device of Fig. 43
of Cox within a left atrial appendage does not inherently
occlude the ostium of the left atrial appendage and it is not clear
that it would be retained within the left atrial appendage upon
implantation, both of which would be required for the device to
serve the intended purpose of a device of Cox.
Id. at 16.
The Examiner responds that the statement of the device being “for an
atrial appendage” “is in the preamble of the claim and does not impart
structure or limit the structure of the claimed invention.” Ans. 5. The
Examiner asserts that the preamble is “merely a recitation of intended use.”
Id. at 6. Moreover, the Examiner asserts that there is support for the device
of Cox being able to be placed in any vascular abnormality in that Cox
explicitly states “‘embodiments of devices and methods herein are directed
to blocking a flow of fluid through a tubular vessel or into a small interior
chamber of a saccular cavity within a mammalian body’” and “an atrial
appendage can reasonably be interpreted as a subset of ‘saccular cavities’
and within the scope of the teachings of Cox.” Id. (quoting Cox ¶ 2). We
agree with the Examiner that the recitation of “for an atrial appendage” is
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merely an intended use and lacks patentable weight. Regardless, and even if
that recitation carries patentable weight, the device of Cox would be capable
of being placed in an atrial appendage, which is all that would be required in
that the claim recites no particular functionality of the device upon its
placement in the atrial appendage. Appellant appears to concede that “a
suitably dimensioned device of Fig. 43 of Cox may physically be positioned
within an atrial appendage.” Appeal Br. 15.
Appellant next argues that:
the Examiner’s proposed modifications of Cox, the exchange of
the proximal end of the device for the distal end of the device
within the aneurysm would place the defect spanning structure
membrane, mesh or microfiber matrix deep within the aneurysm
and would fail to substantially block flow into the defect 106 at
the mouth thereof or otherwise isolate the vascular defect 106
when the device 500 is deployed in an expanded state. Similarly,
relocating the defect spanning structure from the small diameter
proximal end as disclosed by Cox to the large distal end would
also fail to substantially block flow into the defect 106 at the
mouth thereof or otherwise isolate the vascular defect 106 when
the device 500 is deployed in an expanded state. Both of the
proposed modifications to Cox would alter the principle of
operation of the device[,] rendering the resulting device unsuited
for its intended purpose.
Appeal Br. 16–17.
We do not find these arguments persuasive. The Examiner has
explained adequately that having the filter at one end or at the other end of
the device would be dependent on where the device is to be placed in the
body, and also that Cox itself discloses that a filter can be on either end of its
devices depending on the location and orientation of the particular device.
Final Act. 5–6; Ans. 3–4 (citing Cox ¶¶ 176, 201–209, Figs. 20, 25–27).
Appellant has not provided any factual evidence or persuasive technical
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reasoning to explain why ensuring that the defect spanning structure is at the
end of the device that is located at the mouth of the defect, depending upon
how the device is intended to be delivered and employed within the human
body, would have been beyond the level of ordinary skill in the art or
unpredictable to a person of ordinary skill in the art. “A person of ordinary
skill is also a person of ordinary creativity, not an automaton.” KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). We agree with the Examiner
one of ordinary skill in the art would recognize that the device of Cox could
have the defect spanning structure at different ends of an occlusion device
depending upon how and where the occlusion device was going to be placed
in the human body. Final Act. 5.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s determination that Cox renders obvious the subject matter of
independent claim 1. Accordingly, we sustain the rejection of claim 1, and
claims 2–5, 7–14, 16, 18, and 19 falling therewith, under 35 U.S.C. § 103 as
unpatentable over Cox.
Rejection II
Claim 15 recites that “the distal strut ends in part or completely differ
in wall thickness and/or a strut width from the other struts of the cage-like
structure.” Appeal Br. 21 (Claims App.). The Examiner determines that
Cox does not explicitly teach this feature, although the Examiner notes that
Cox teaches that the struts may have a variety of cross-sections. Final
Act. 11 (citing Cox ¶ 126). The Examiner turns to Ferrera, finding that
“Ferrara teaches an implantable cage device in which the struts have varying
thicknesses.” Id. (citing Ferrera ¶¶ 41, 246, 285). The Examiner also finds
that “Ferrera teaches that varying the thickness of the struts allows the
device to be more flexible overall, as well as allowing the device to bend in
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more directions without breaking.” Id. at 11–12 (citing Ferrera ¶ 285). The
Examiner concludes that it would have been obvious “to modify the device
as taught by Cox to include varying strut thickness as taught by Ferrera at
the distal strut ends so as to impart additional flexibility to the device
ensuring that it is sufficiently flexible to fill the desired space.” Id. at 12.
Appellant argues that the Examiner’s stated reasoning “does not
appear to address a disclosed deficiency of the device of Cox which is not
disclosed as requiring flexibility or bending” and that “there appears to be no
expressed motivation for one of ordinary skill in the art to modify the
structure of Cox to address a problem which does not appear explicitly to be
present in the devices of Cox.” Appeal Br. 17–18. To the extent that
Appellant is insisting on an explicit teaching, suggestion, or motivation in
Cox for the Examiner’s proposed modification, such an argument has been
foreclosed by the Supreme Court. KSR, 550 U.S. at 419 (stating that a rigid
insistence on teaching, suggestion, or motivation is incompatible with its
precedent concerning obviousness). Rather, the Court requires that we look
to whether the Examiner has provided “some articulated reasoning with
some rational underpinning to support the legal conclusion of obviousness.”
In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (cited with approval in KSR,
550 U.S. at 418). Here, where Cox has a device with arched struts with a
“reverse bend at each end” (Cox ¶ 203, Fig. 43), the Examiner has
adequately explained why Ferrera’s teachings of varying strut thickness for
flexibility and/or bending are relevant to Cox. Moreover, it is not necessary
for a determination of obviousness that the reference to be modified
recognize or acknowledge a deficiency with its own design in order to
provide a motivation to modify or improve it. See KSR, 550 U.S. at 417
(“[I]f a technique has been used to improve one device, and a person of
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ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.”).
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s determination that the combination of Cox and Ferrera
renders obvious the subject matter of dependent claim 15. Accordingly, we
sustain the rejection of claim 15 under 35 U.S.C. § 103 as unpatentable over
Cox and Ferrera.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 7–14,
16, 18, 19
103 Cox 1–5, 7–14,
16, 18, 19

15 103 Cox, Ferrera 15
Overall
Outcome
1–5, 7–16,
18, 19

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED