BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Nov 19, 2021

2021002922 (P.T.A.B. Nov. 19, 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.
15/956,824 04/19/2018 Nicholas Lee Tassoni 2001.1780101 2321
11050 7590 11/19/2021
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
BYRD, BRIGID K
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
11/19/2021 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 NICHOLAS LEE TASSONI, KHOI LE, and
JEFFRY D. JOHNSON

Appeal 2021-002922
Application 15/956,824
Technology Center 3700
____________

Before JOHN C. KERINS, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–18 and 20. See Final Act. 1 (Office
Action Summary). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM the Examiner’s rejections of these claims.

1 We use the word “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.
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CLAIMED SUBJECT MATTER
The disclosed subject matter “pertains to medical devices and
methods for manufacturing and/or using medical devices.” Spec. 1:10–11.
System claims 1 and 17, and method claim 20, are independent. Claim 1 is
illustrative of the claims on appeal and is reproduced below.
1. A vascular occlusion system, comprising:
a microcatheter configured to navigate a vasculature;
an elongate shaft slidably disposed within a lumen of the
microcatheter, the elongate shaft having a lumen extending from
a proximal end of the elongate shaft to a distal end of the elongate
shaft;
a plurality of occlusive medical devices releasably
connected to the elongate shaft in series; and
a release wire slidably disposed within the elongate shaft
and at least a portion of each of the plurality of occlusive medical
devices;
wherein the release wire sequentially secures the plurality
of occlusive medical devices to the distal end of the elongate
shaft when the release wire is disposed within at least a portion
of each of the plurality of occlusive medical devices,
wherein the release wire includes one or more indicators
proximate a proximal end of the release wire configured to
communicate to a user of the vascular occlusion system how
many of the plurality of occlusive medical devices have been
released when the release wire is partially withdrawn from the
elongate shaft.
EVIDENCE
Name Reference Date
Buiser et al. (“Buiser”) US 2007/0083226 A1 Apr. 12, 2007
Lee at al. (“Lee”) US 2014/0236127 A1 Aug. 21, 2014
Jones et al. (“Jones”) US 2015/0335333 A1 Nov. 26, 2015
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REJECTIONS
Claims 1–13, 17, 18, and 20 are rejected under 35 U.S.C. § 103 as
unpatentable over Buiser and Lee.
Claims 14–16 are rejected under 35 U.S.C. § 103 as unpatentable over
Buiser, Lee, and Jones.
ANALYSIS
The rejection of claims 1–13, 17, 18, and 20
as unpatentable over Buiser and Lee
Appellant argues the three independent claims (i.e., claims 1, 17, and
20) together. See Appeal Br. 8–11. Appellant’s arguments with respect to
dependent claims 2–13 and 18 are that they depend from an allowable
independent claim. See Appeal Br. 11. We select claim 1 for review, with
the remaining claims (i.e., claims 2–13, 17, 18, and 20) standing or falling
with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv) (2019).
The Examiner primarily relies on the teachings of Buiser for
disclosing the limitations of claim 1, including the disclosure of “a plurality
of occlusive medical devices” and “a release wire (control wire 106).” Final
Act. 5 (referencing Buiser ¶¶ 47, 62). However, the Examiner
acknowledges that “Buiser fails to explicitly disclose wherein the release
wire includes one or more indicators” used to communicate “how many of
the plurality of occlusive medical devices have been released” as recited.
Final Act. 7. The Examiner relies on Lee for also teaching a release wire but
importantly, “wherein the release wire includes one or more indicators” as
recited. Final Act. 7 (referencing Lee ¶ 48). The Examiner, thereafter,
provides a reason for combining Buiser and Lee, i.e., it would have been
obvious “to modify Buiser’s device to include indicators, as taught by Lee,
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in order to alert the operator when the plurality of occlusive medical device
have been released from the delivery device,” and also “how many.” Final
Act. 7.
Appellant disagrees contending that Lee fails to provide “indication of
how many of [the] medical devises have been released, because the
reference teaches a system with a single implant.” Appeal Br. 9. In other
words, “Lee fails to teach or suggest their system as being capable of being
used to deliver multiple implants” because “Lee teaches a single implant.”
Appeal Br. 9.
Appellant’s contentions are not persuasive of Examiner error because
the Examiner relies on Buiser for disclosing the release of multiple implants,
not Lee.2 See, e.g., Buiser ¶¶ 47 (“first embolic coil 16” and “second
embolic coil 26”), 64 (using a control wire for “pushing the coils out of the
catheter or retracting the catheter”). The Examiner relies on Lee as teaching
providing an indicator on a control wire to signal that a medical device has
been released, and determines that the person of ordinary skill in the art
would recognize that multiple indicators could be used (“capable of
communicating . . . how many”) if multiple medical devices are to be
released. Final Act. 7; see also Lee ¶ 48 (discussing disengaging “the male
coupler 56 from the female coupler 40” and that “the control member 70
may include a marker (not shown) near its proximal end to alert the operator
when the male coupler 56 has been completely withdrawn from the female
coupler 40”). Thus, Appellant’s focus on Lee for purportedly pertaining to a

2 Appellant acknowledges, “Buiser teaches a system involving multiple
coils.” Appeal Br. 9.
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single implant is not commensurate with the Examiner’s rejection, or the
teachings the Examiner relied on Lee for.
Appellant also contends the Examiner relied on “hindsight” in
reaching this rejection. See Appeal Br. 9; see also Reply Br. 3 (“the only
rational reason for modifying Buiser with Lee is based on impermissible
hindsight”). We disagree because, as expressed by the Examiner, Lee’s use
of a marker to indicate when a male/female uncoupling occurred would
“teach an indication of how many . . . devices have been released when
[Buiser’s] release wire is partially withdrawn.” Final Act. 7–8 (referencing
Buiser ¶¶ 62, 64). Appellant does not explain how using a marker on a wire
to designate a release as taught by Lee was gleaned only from Appellant’s
Specification.
Appellant further argues that there is no reason to combine Buiser and
Lee because “Buiser already teaches using radiopaque markers on the coils,”
and as such, “[t]he addition of the marker of Lee would appear to be
redundant to the system of Buiser.” Appeal Br. 10; see also Buiser ¶ 77
(“[a]t least one of the coils may include a radiopaque marker”). In other
words, as per Appellant, “Buiser already teaches markers that would
communicate to the user how many of the plurality of coils have been
released.” Appeal Br. 11.
The Examiner responds,
the engaging members of the coils cannot be retracted or moved
until the control wire extending through the engaging members
is retracted (Para. [0062] of Buiser). Therefore, one of ordinary
skill would’ve understood indication means comprised
specifically on the control wire to be useful, since the control
wire has to be retracted a sufficient distance to deploy the coils.
Ans. 4. Continuing in this vein, the Examiner reasons
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Therefore, one of ordinary skill would’ve understood the
indication means of Lee could be included on a control wire, in
a specific location, to communicate when an implant, or
multiple implants, have been deployed due to retraction of the
control wire, which would communicate how many implants
would be deployed.
Ans. 4. The Examiner also states, “the motivation is to alert the operator
when the implant has been uncoupled from the delivery device.” Ans. 4.
Appellant disagrees with this assessment stating that Buiser’s
radiopaque “markers could be viewed during deployment to determine the
position of each marked coil/engaging member relative to the aneurysm.”
Reply Br. 2. Appellant continues stating “[h]aving the markers on the
coils/engaging members would provide the operator the ability to see where
each marked coil was positioned.” Reply Br. 2.
We agree with Appellant that the radiopaque marker would enable a
user to ascertain the position of the medical device when viewed on a screen,
but the Examiner’s rationale is not premised on the position of the medical
device, but on whether or not the medical device has been deployed or
uncoupled from the installing catheter. Lee specifically teaches the use of a
marker for this exact purpose, i.e., the ability to ascertain when an
uncoupling has occurred (see Lee ¶ 48), regardless of where in the body the
device may be located. We thus do not fault the Examiner for finding that a
skilled person “would’ve understood indication means comprised
specifically on the control wire to be useful,” such as “to communicate when
an implant, or multiple implants, have been deployed.” Ans. 4.
Appellant’s further argument contending that by placing markers on
the control wire, the Examiner “would remove this feature” (i.e., remove
Buiser’s radiopaque coating) (Reply Br. 2) is not only unsupported by the
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record but is also without merit because there is no reason they cannot each
be employed for their own special purpose. Appellant also argues that “the
single marker would still fail to provide any information regarding how
many implants were released” (Reply Br. 2), but again, Appellant is too
narrowly applying Lee’s teaching as something of a bodily incorporation in
which only a single marker is ever employed, and does not account for the
Examiner’s use of Lee’s disclosure of using a marker to indicate release of a
medical device, as applied to the release of a plurality of devices, and using
a corresponding plurality of markers to indicate the separation of each of the
devices.
In summation, and based on the record presented, we sustain the
Examiner’s rejection of claims 1–13, 17, 18, and 20 as being obvious in
view of Buiser and Lee.
The rejection of claims 14–16
as unpatentable over Buiser, Lee, and Jones
Appellant argues dependent claims 14–16 together. See Appeal Br.
11–12; Reply Br. 3. We select claim 14 for review, with claims 15 and 16
standing or falling therewith.
Claim 14 depends directly from claim 1 and further recites “a second
release wire” disposed within the catheter. The Examiner relies on the
additional reference to Jones for teaching “a second release wire
(engagement member 170)” as recited. Final Act. 21. The Examiner
reasons that it would have been obvious to combine Jones’ teachings with
that of Buiser and Lee “in order to maintain secure coupling of the embolic
coil with the delivery member until desired release of the coil, which would
prevent unwanted release of the coils until reaching the target location
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within the body.” Final Act. 21; see also Ans. 4 (both referencing Jones
¶ 76).
Appellant disputes that there is a “rational reason” for combining
Jones with that of Buiser and Lee stating that adding Jones’ second release
wire for security purposes to prevent unwanted release is improper “as
Buiser already teaches a structure that achieves these goals.” Appeal Br. 11,
12. Appellant contends that “Buiser already teaches the coil(s) being
securely coupled to the pusher wire 46 via the engaging members 22
(embodiment in FIGS 1 and 2A) and also teaches the coil 128 being securely
coupled to the pusher wire 130 via the engaging members 132 and the
control wire 106 (embodiment in FIG 7A).” Appeal Br. 12. In each of these
embodiments, Buiser maintains inter-coupling via the sole wire extending
through the corresponding engaging members, the same as depicted in
Appellant’s Figures 2–5. This single wire is the only bulwark against an
undesired deployment depicted in Buiser. However, the Examiner is relying
on Jones for its teaching of “a second release wire” to “prevent unwanted
release” by inadvertent withdrawal of Buiser’s sole wire “until reaching the
target location within the body.” Final Act. 21 (referencing Jones Fig. 3B,
item 170, and ¶ 76); see also Ans. 4–5.
Appellant does not explain why the desire to insure against unwanted
deployment is not a “rational reason” to do so. Appeal Br. 11. We further
note that Jones’ teaching of additional security is quite similar to,
structurally and operationally, Appellant’s solution. Compare Jones Fig. 3B
and ¶ 76, with Appellant’s Figs. 6, 7 and Spec. 22:27 to 24:24. Hence,
Appellant’s overly optimistic characterization of Buiser’s couplers above,
while at the same time discussing a manner of achieving greater security
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with respect to Appellant’s couplers, is not persuasive that the Examiner
erred by seeking to restrain Buiser’s couplers with the same level of security
taught by Jones. See Ans. 5 (“Buiser could be modified with Jones to
prevent unwanted release of the coils” such as by “preventing unwanted
retraction” of Buiser’s control wire).
In Appellant’s Reply Brief, Appellant takes a different approach,
focusing upon the embodiment depicted in Figure 8 of Buiser. See Reply
Br. 3. However, there is no indication why this focus on this different
embodiment could not have also been presented in Appellant’s Appeal Brief
when Appellant discussed the embodiments of Figures 1, 2A, and 7A of
Buiser (as noted above and which were addressed by the Examiner). On this
point, 37 C.F.R. § 41.41(b)(2) states, “[a]ny argument raised in the reply
brief which was not raised in the appeal brief . . . will not be considered by
the Board for purposes of the present appeal, unless good cause is shown.”
Here, good cause has not been shown as to why this Figure 8 embodiment of
Buiser could not have also been addressed when Appellant discussed the
Figure 1, 2A, and 7A embodiments of Buiser. We thus decline to consider
this new argument focusing on this different embodiment, especially when
the Examiner was not provided an opportunity to respond to this different
embodiment when responding to the other embodiments.
Appellant also contends that there is “no rational reason” for the
combination with Jones “other than looking to Appellant’s specification,
which is an error.” Appeal Br. 11. However, we do not abide by
Appellant’s charge of “hindsight” when the feature identified and the
benefits achieved are already known in the art.
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Appellant also contends that “Jones fails to teach any configuration in
which either member is prevented from being proximally retracted.” Reply
Br. 3. However, this is not a correct reading of cited paragraph 76 of Jones
(see Final Act. 20, 21; Ans. 4), which specifically teaches that Jones’
corresponding “second release wire” 170 (Final Act. 21) is “slidably
positioned” within the delivery member. Note also Jones’ discussion of
other “release member 180” being retracted from a “first configuration”
(where its distal end is in engagement with the distal end of wire 170 (see
Jones Fig. 3)) to a “second configuration” where member 180 “is moved
proximally.” Jones ¶ 76. Hence, Appellant’s contention regarding the lack
of movement of Jones’ members is not persuasive of Examiner error.
Further, and of perhaps greater importance, is the fact that claim 14 is devoid
of language requiring either member to be “prevented from being proximally
retracted” as argued by Appellant.
Accordingly, and based on the record presented, we sustain the
Examiner’s rejection of claims 14–16 as being obvious in view of Buiser,
Lee, and Jones.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
References/Basis Affirmed Reversed
1–13, 17,
18, 20
103 Buiser, Lee 1–13, 17,
18, 20

14–16 103 Buiser, Lee, Jones 14–16
Overall
Outcome
1–18, 20
TIME PERIOD FOR RESPONSE
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Application 15/956,824

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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)(1)(iv).

AFFIRMED