Boston Scientific Scimed, Inc.

Patent Trials and Appeals Board

Sep 30, 2021

2021002357 (P.T.A.B. Sep. 30, 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.
15/003,308 01/21/2016 John Alan O'Brien 8150BSC0269 9324
121974 7590 09/30/2021
Kacvinsky Daisak Bluni PLLC (8150)
2601 Weston Parkway, Suite 103
Cary, NC 27513
EXAMINER
TYSON, MELANIE RUANO
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
09/30/2021 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):
docketing@kdbfirm.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN ALAN O’BRIEN,
CONOR O’SULLIVAN, and FRANK RYAN

Appeal 2021-002357
Application 15/003,308
Technology Center 3700
____________

Before MICHAEL J. FITZPATRICK, BRANDON J. WARNER, and
MICHAEL L. WOODS, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant, Boston Scientific Scimed, Inc.,1 appeals under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 1–4, 6, 7, 21–
24, 26–30, 32, and 33. Final Act. 1. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies itself as the real party in interest. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification
The Specification’s disclosure “relates generally to occlusive devices
for creating vascular occlusions.” Spec. ¶2. Such “[v]aso-occlusive devices
are implants that are placed within the vasculature of the body . . . to block
the flow of blood through a vessel making up that portion of the vasculature
via the formation of an embolus or to form an embolus within an aneurysm
or other structure stemming from the vessel.” Id. ¶3. They “are typically
implanted using a delivery catheter that is advanced endoluminally to the
treatment site.” Id. “An example of a well-known vaso-occlusive device
has an elongated helically-wound device having ‘primary shape’ when
constrained within a delivery catheter, and a three-dimensional ‘secondary’
[(or ‘memorized’ per the claims)] shape once deployed from the catheter and
left, more or less, unconstrained in the implantation site.” Id. ¶4.
The Claims
Claims 1–4, 6, 7, 21–24, 26–30, 32, and 33 are rejected. Final Act. 1.
No other claims are pending. Id. Claim 1 is representative and reproduced
below.
1. An occlusion device having a memorized spherical
shape and comprising a single wire having a memorized shape in
which the wire comprises a spherical outer wire layer having a
first axis and a spherical inner wire layer having a second axis
disposed within the spherical outer wire layer, wherein the outer
wire layer comprises a first spherical helix about the first axis,
wherein the first axis and the second axis are substantially
perpendicular to each other.
Appeal Br. 17.
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The Examiner’s Rejections
Pursuant to 35 U.S.C. § 103, the Examiner made the following
rejections:
1. claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Ken2
(Final Act. 4);
2. claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over
Dieck3 (id. at 7);
3. claims 1–4, 7, 21–24, 27–30, and 33 as unpatentable over Dieck
and Ken (id. at 11);
4. claims 6, 26, and 32 as unpatentable over Ken and O’Connor4
(id. at 14); and
5. claims 6, 26, and 32 as unpatentable over Dieck, Ken, and
O’Connor (id. at 15).
DISCUSSION
Rejection 1
The Examiner rejected claims 1–4, 7, 21–24, 27–30, and 33 as
unpatentable over Ken. Final Act. 4. Appellant argues against the rejection
of these claims together. Appeal Br. 8–11. We select claim 1 as
representative. See 37 C.F.R. § 41.37(c)(1)(iv) (“When multiple claims
subject to the same ground of rejection are argued as a group or subgroup by
appellant, the Board may select a single claim from the group or subgroup
and may decide the appeal as to the ground of rejection with respect to the
group or subgroup on the basis of the selected claim alone.”).

2 US 5,749,891, issued May 12, 1998 (“Ken”).
3 US 2008/0221600 A1, published Sept. 11, 2008 (“Dieck”).
4 US 2008/0221554 A1, published Sept. 11, 2008 (“O’Connor”).
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Ken discloses “a vaso-occlusive device comprising one or more vaso-
occlusive helical coils which are formed by first winding a wire into a first
helix; the first helix is then wound into a secondary form which is wound
back onto itself to form two or more layers of the primary coil.” Ken 2:42–
45. The Examiner found that Ken expressly teaches or suggests all of the
subject matter of claim 1. Final Act. 4–5, 7 (citing Ken 2:48–50, 3:6–12,
6:23–33, Figs. 2A–2C); see also Ken Fig. 3 (discussed by Ken at 6:23–33).
Appellant argues that “the outer layer 138 and inner layers 132, 134 of
the linear coil of FIG. 2C of Ken are formed with the linear mandrels” and,
thus, “could not form perpendicular ‘spherical’ or ‘variable diameter’
constructions of the inner and outer wire layers as recited in the independent
claims.” Appeal Br. 9 (citing Ken 5:65–6:7, 7:20–35). But Ken is not
limited to linear coils. In that regard, and as the Examiner points out in the
Final Action, “Ken teaches that[,] in addition to the memorized tubular
shape illustrated, the occlusion device may also have an overall memorized
spherical shape and suggests the inner layer may also have a spherical shape
corresponding to the spherical shape of the outer layer.” Final Act. 7 (citing
Ken, Abstract, 2:48–50, 6:23–30).
Appellant further argues that Ken’s disclosure of a spherical shape is
limited to “the overall form of the coil and [is] not a description of ‘a
spherical inner wire layer,’” as recited in claim 1. Appeal Br. 11. However,
as the Examiner points out, the rejection relies on Ken’s disclosure “that
‘The inner layers (not shown in Figure 3) may either correspond in shape to
the outer layer (142) or may be columnar or tubular as shown in earlier
Figures.’” Ans. 14 (citing Ken 6:29–33). In other words, the inner coil
layers of Ken are not necessarily columnar or tubular shaped, as Appellant
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argues, but instead “may . . . correspond in shape to the outer layer,” (Ken
6:29–30), which itself may be “ovoid” (id. at 6:26) or “generally spherical or
ovoid” (id. at 2:48–49).
Appellant additionally argues that “constructi[ng] such an
orthogonally layered occlusive device as purported in the Advisory Action
using the disclosed methods of FIGS. 6A through 6E appears unlikely, if not
impossible, and certainly a suggestion that would not be obvious to one of
skill in the art.” Appeal Br. 10 (emphasis added); see also id. at 17 (claim 1
reciting that “the first axis and the second axis are substantially
perpendicular to each other”). This argument is not persuasive, as neither
the Final Action nor the Advisory Action relies on the method(s) disclosed
in Ken Figures 6A–6E for the rejection.
Figures 6A–6E illustrate a step-by-step “procedure for winding a coil
such as shown in FIGS. 2A to 2C according to the invention.” Ken 3:40–41;
see also id. at 7:20–35 (describing the procedure). The Examiner does cite
Figures 2A–2C for teaching many of the features of claim 1, including an
occlusion device having a memorized shape formed of a single wire in
which an outer and inner layers have axes perpendicular or orthogonal to
each other. Final Act. 4–5. However, the Examiner additionally relies on
Figure 3 and on Ken’s explicit disclosure that, instead of the columnar
shapes of the layers of Figures 2A–2C, Ken’s vaso-occlusive device may
have an outer layer that is “general spherical or ovoid shape” and inner
layers that “may correspond” thereto. Ken 2:48–50, 6:23–33.
We have considered Appellant’s arguments, but they do not apprise us
of error in the Examiner’s rejection of claim 1 as unpatentable over Ken.
Accordingly, we affirm this rejection of claim 1 as well as that of claims 2–
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4, 7, 21–24, 27–30, and 33, which fall therewith. 37 C.F.R.
§ 41.37(c)(1)(iv).
Rejection 2
The Examiner also rejected claims 1–4, 7, 21–24, 27–30, and 33 as
unpatentable over Dieck. Final Act. 7. Appellant argues against the
rejection of these claims together. Appeal Br. 11–13. We select claim 1 as
representative. See 37 C.F.R. § 41.37(c)(1)(iv).
Dieck discloses “devices . . . to occlude blood vessels, such as
endoleaks, to improve the isolation of aneurysms.” Dieck, Abstract. The
Examiner found that Dieck discloses all of the subject matter of claim 1
except for the occlusion device “comprising a single wire,” as recited in
claim 1. Final Act. 7–8, 10 (citing Dieck ¶64, Figs. 18A–18C). The
Examiner determined:
It would have been obvious to one having ordinary skill in the art
before the effective filing date of the claimed invention to form
Dike’s [sic, Dieck’s] inner and outer wire layers from a single
wire since it has been held that the use of a one piece of
construction instead of the structure disclosed in the prior art
would be merely a matter of obvious engineering choice.
Final Act. 10 (citing In re Larson, 340 F.2d 965, 968 (CCPA 1965)).
Appellant argues that “the coil formation methods of Dieck are unable
to produce the single wire comprising inner and outer wire layers as recited.”
Appeal Br. 12. Appellant neither supports this argument with factual
evidence or technical reasoning, nor explains why, if accurate, it would
support non-obviousness. The Examiner’s rejection is based on a
modification to Dieck.
Appellant also argues that the Examiner’s proposed modification of
Dieck’s Figure 18 embodiment is incompatible with the teachings of Dieck
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and, thus, the modification “requires impermissible hindsight bias.” Appeal
Br. 13. In that regard, Appellant points out that in the two-wire (or two-coil)
embodiment of Figure 18, “the first coil 60 engages the smaller ends of the
second coil 62 and vice versa.” Id. (quoting Dieck ¶64). Based on this
disclosure, Appellant asserts that this engagement of Dieck’s inner and outer
coils thus “necessitates four ends of wires” (or coils), whereas in the
proposed modification would be only two ends. Id. We are not persuaded
by this argument. Dieck does not describe the engagement of the two ends
of one coil engaging the other coil and vice versa as being necessary.
Moreover, if there were only one coil as per the Examiner’s modification, all
portions of such coil would be integral and thus not disengaged.
Appellant’s assertion of “impermissible hindsight bias” is also not
persuasive. Appeal Br. 13. The Examiner articulated an adequate reason
why a person of ordinary skill in the art would have made the proposed
modification, namely because “use of a one piece of construction instead of
the [two piece] structure disclosed in the prior art would be merely a matter
of obvious engineering choice.” Final Act. 10 (citing In re Larson, 340 F.2d
965 (CCPA 1965)). Larsen indeed supports this proposition. 340 F2d. at
967–968 (finding that “the brake disc and clamp of Tuttle et al. comprise
several parts” and holding “the use of a one piece construction instead of the
structure disclosed in Tuttle et al. would be merely a matter of obvious
engineering choice”). Appellant has not distinguished Larsen or otherwise
rebutted the Examiner’s reason for the proposed modification. As such, the
assertion of impermissible hindsight bias is unpersuasive. See In re Cree,
Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (explaining that a hindsight
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argument is of no moment where an examiner provides a sufficient, non-
hindsight reason to modify/combine prior art).
We have considered Appellant’s arguments, but they do not apprise us
of error in the Examiner’s rejection of claim 1 as unpatentable over Dieck.
Accordingly, we affirm this rejection of claim 1 as well as that of claims 2–
4, 7, 21–24, 27–30, and 33, which fall therewith. 37 C.F.R.
§ 41.37(c)(1)(iv).
Rejection 3
The Examiner also rejected claims 1–4, 7, 21–24, 27–30, and 33 as
unpatentable over Dieck and Ken. Final Act. 11. Appellant argues against
the rejection of these claims together. Appeal Br. 13–14. We select claim 1
as representative. See 37 C.F.R. § 41.37(c)(1)(iv).
The instant rejection of claim 1 relies on Dieck in the same manner as
in Rejection 2. Final Act. 11–12. However, instead of relying on design
choice for using a single wire instead of Dieck’s two wires, the instant
rejection relies on Ken’s express teaching of a single wire vaso-occlusion
device and the predictable result of incorporating such a feature into Dieck.
Id. at 14 (citing Ken 2:42–3:12, 3:52–67).
Appellant’s arguments against this rejection are limited to those
already considered above. Appeal Br. 14. Those arguments likewise are
unpersuasive here.
Accordingly, we affirm this rejection of claim 1 as well as that of
claims 2–4, 7, 21–24, 27–30, and 33, which fall therewith. 37 C.F.R.
§ 41.37(c)(1)(iv).
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Rejections 4 and 5
The Examiner rejected claims 6, 26, and 32 as unpatentable over Ken
and O’Connor and also over Ken, Dieck, and O’Connor. Final Act. 14–15.
Claims 6, 26, 32 recite “an atraumatic distal coil tip.” Appeal Br. 17, 19, 20.
In these rejections, the Examiner relies on O’Connor for teaching this
feature. Final Act. 14 (citing O’Connor ¶¶66, 70), 15 (same). Appellant
does not present any additional arguments separate from those discussed
above with respect to Rejections 1 and 3, asserting only that O’Connor does
not remedy the asserted deficiencies. Appeal Br. 14. Those arguments
likewise are unpersuasive here, and we thus affirm these rejections.
DECISION SUMMARY
In summary:

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 7,
21–24,
27–30, 33
103 Ken 1–4, 7, 21–
24, 27–30,
33

1–4, 7,
21–24,
27–30, 33
103 Dieck 1–4, 7, 21–
24, 27–30,
33

1–4, 7,
21–24,
27–30, 33
103 Dieck, Ken 1–4, 7, 21–
24, 27–30,
33

6, 26, 32 103 Ken, O’Connor 6, 26, 32
6, 26, 32 103 Dieck, Ken,
O’Connor
6, 26, 32
Overall
outcome
1–4, 6, 7,
21–24, 26–
30, 32, 33

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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