BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Oct 16, 2020

15237270 - (D) (P.T.A.B. Oct. 16, 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.
15/237,270 08/15/2016 CLAUDE O. CLERC 1001.3899101 8370
11050 7590 10/16/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
SNOW, BRUCE EDWARD
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/16/2020 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 CLAUDE O. CLERC,
JOHN A. HINGSTON,
MARK RIVARD, and
ARNOLD M. HERSKOVIC

Appeal 2020-000815
Application 15/237,270
Technology Center 3700
____________

Before MICHAEL L. HOELTER, JEREMY M. PLENZLER, and
LEE L. STEPINA, 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 1–13, 15–17, 19, and 20, which

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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constitute all the claims pending in this application. See Appeal Br. 7. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM the Examiner’s rejection of these claims.
CLAIMED SUBJECT MATTER
The disclosed subject matter “pertains to medical devices, and
methods for manufacturing medical devices.” Spec. 1:9–10. Apparatus
claims 1, 16, and 20 are independent. Claim 1 is illustrative of the claims on
appeal and is reproduced below.
1. A medical device, comprising:
a stent including a plurality of longitudinally extending
filaments, the stent having an inner surface, an outer surface
and a proximal end;
a plurality of tubular members extending along the stent;
wherein each of the plurality of tubular members is
coupled with one or more of the plurality of longitudinally
extending filaments; and
a plurality of strands including a first strand fully loaded
into a first tubular member of the plurality of tubular members
and a second strand fully loaded into a second tubular member
of the plurality of tubular members, wherein each strand
includes a plurality of radioactive seeds and spacers surrounded
by a covering, and wherein the first strand includes a first
radioactive seed being the proximal most radioactive seed of
the first strand, positioned a first distance from the proximal
end of the stent, and wherein the second strand includes a
second radioactive seed being the proximal most radioactive
seed of the second strand, positioned a second distance from the
proximal end of the stent, and wherein the first distance is
different than the second distance;
wherein each of the plurality of strands is removably
positioned in one of the plurality of tubular members.
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EVIDENCE
Name Reference Date
Herskovic2 WO 2014/031950 A1 Feb. 27, 2014
REJECTION3
Claims 1–13, 15–17, 19, and 20 are rejected under 35 U.S.C. § 103 as
obvious over Herskovic.
ANALYSIS
Appellant argues the three independent claims 1, 16, and 20 together.
See Appeal Br. 7–13. We select claim 1 for review, with claims 16 and 20
standing or falling with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). Appellant
also presents separate arguments for dependent claim 4 and dependent claim
11. See Appeal Br. 13–14. Regarding remaining claims 2, 3, 5–10, 12, 13,
15, 17, and 19, Appellant contends that since their respective independent
claims are allowable, these claims are also “patentable over Herskovic.”
Appeal Br. 14. No further separate argument is presented for these
remaining claims and thus they stand or fall with their respective parent
claim. Accordingly, we select claims 1, 4, and 11 for review.
Claim 1
Claim 1 recites a stent having a proximal end and a plurality of
tubular members extending along the stent. Claim 1 further recites a first

2 The Examiner references “US equivalent 2015/0190654” dated July 9,
2015. Final Act. 4. We do the same.
3 The Examiner withdrew the rejection of all the claims under 35 U.S.C.
§ 102(a)(1). Final Act. 2 (“the anticipation portion of the rejection which the
examiner has withdrawn”).
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strand “loaded into a first tubular member” and a second strand “loaded into
a second tubular member.” Claim 1 recites that “each strand includes a
plurality of radioactive seeds and spacers” and that the “radioactive seed of
the first strand” is located “a first distance from the proximal end” while the
“radioactive seed of the second strand” is located “a second distance from
the proximal end.” What is of further importance is the recitation “wherein
the first distance is different than the second distance.”
“Appellants argue that Herskovic teaches that proximal most
radioactive seeds of the first strand and the second strand will align with
each other and not have a different distance from the proximal end of the
stent.” Appeal Br. 8; see also Reply Br. 4. Appellant relies on Figure 2 of
Herskovic for such support stating “[t]he figure clearly shows the axial
alignment of the first and second seeds of a first and second strand.” Appeal
Br. 8 (referencing Herskovic ¶¶ 25 and 66 (of the U.S. equivalent)); see also
Reply Br. 3. Appellant additionally references Figure 3 of Herskovic stating
“Appellants note that the two outer sleeves shown in FIG. 3 are shown
having substantially equal lengths and being substantial aligned.” Appeal
Br. 10 (citations omitted); see also id. at 11 (“Appellants maintain that at
least FIG. 2 and FIG. 3 support that the proximal most seeds in adjacent
strands will longitudinally align with one another.”), Reply Br. 2–4
(“Appellants maintain that at least FIG. 2 (and FIG. 3) support that the
proximal most seeds in adjacent strands will be longitudinally aligned with
one another.”).
However, the various paragraphs referenced by Appellant in support
of the above contentions are silent to the effect that Herskovic teaches that
the radioactive seeds of adjacent strands are only axially aligned, or that such
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respective seeds are not to ever be misaligned. Herskovic instead teaches
the ability “to adjust the position . . . of the radioactive source . . . in
response to changes in tumor shape and size, carrier position, and other
relevant therapeutic factors.” Herskovic ¶ 14. In particular, paragraph 15 of
Herskovic teaches that “[t]he device should also allow the radioactive
sources to be positioned in a preformed geometry that is customized to
patient anatomy and the target tissue.” More tellingly, paragraph 67 of
Herskovic teaches the use of spacers to “maintain the desired geometry of
the radioactive particles 20 relative to each other” and that “additional
spacers or combinations thereof” may be employed. To be clear, paragraph
71 of Herskovic teaches that “[t]he position of the radioactive particles
relative to the target tissue can be adjusted by changing the order and
position of the spacers 22 and radioactive particles 20 in situ at a later time
after stent insertion.” Hence, in view of the above, the radioactive seeds of
adjacent strands may or may not be in perfect alignment with each other.
As a consequence, even should Herskovic’s drawings illustrate perfect
alignment between the strand’s radioactive seeds as Appellant contends
above, such drawings do not preclude misalignment between them (i.e.,
differences in their respective distances from the stent’s proximal end) in
view of Herskovic’s express teachings. See Ans. 6 (“Appellant does not
specifically cite any part of the specification [of Herskovic] that inherently
teaches the first distance is the same as the second distance.”).
Appellant disputes that Herskovic discloses such misalignment
stating, “there is nothing in [Herskovic’s] specification that supports that the
arrangement of seeds and spacers in adjacent strands may be different.”
Appeal Br. 10; see also id. at 11, Reply Br. 2–5. However, in view of the
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redundant teachings in Herskovic cited above, Appellant’s contention is not
persuasive. In other words, because Herskovic teaches variable alignment
between radioactive particles of the various strands, we are not persuaded by
Appellant’s reliance on Herskovic’s figures in an attempt to restrict
Herskovic to only disclosing radioactive particles in adjacent strands as
solely being axially aligned.
Additionally, Appellant’s reliance on Herskovic’s figures as
disclosing equal distances from the proximal end of the stent (i.e., axial
alignment) is contrary to guidance provided by our reviewing court. For
example, we have been instructed that drawings in a patent are merely
illustrative of the principles embodied therein and do not define the precise
proportions of elements relied upon. See In re Kinderman, 178 F.2d 937
(CCPA 1949). In other words, “patent drawings do not define the precise
proportions of the elements and may not be relied on to show particular sizes
if the specification is completely silent on the issue.” Hockerson-
Halberstadt, Inc. v. Avia Group Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir.
2000). Not only may patent drawings, in general, not be relied upon for
“precise proportions” should the patent be silent as to such drawings being
to scale; but here, Herskovic’s Specification is not silent on the issue at
hand. Instead, as indicated above, Herskovic specifically discusses the
ability to adjust the location of the radioactive seeds as needed in order to
customize the strands to conform to the shape and size of the target tissue, as
well as stent position. See Herskovic ¶¶ 14, 15; see also Ans. 7–9. Thus,
Appellant’s focus on Herskovic’s figures without addressing the express
teachings of Herskovic (see Appeal Br. 8, 9, Reply Br. 2–5) is not persuasive
that the Examiner erred in finding claim 1 obvious.
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Appellant additionally contends that “the Examiner appears to be
basing the rejection on an opinion rather than the actual teachings of the
reference.” Reply Br. 4. However, Appellant does not indicate how the
Examiner’s findings can be based “on an opinion rather than the actual
teachings” of Herskovic when such findings are, instead, based on
Herskovic’s express teachings. Appellant also contends that “Appellants
argue that the Examiner’s position offers no evidence outside of that taught
by Herskovic.” Reply Br. 4; see also id. at 5. However, Appellant fails to
indicate why or how Herskovic’s teachings might be lacking or deficient or
otherwise in need of further clarification or support.
Appellant additionally seems to consider the Examiner’s rejection as
one based on anticipation instead of obviousness. This is because Appellant
addresses inherency stating that “the fact that a certain characteristic may
occur in Herskovic is not sufficient.” Appeal Br. 11. Such arguments are
not persuasive that the Examiner erred in determining that claim 1 would
have been obvious in view of Herskovic.
Furthermore, Appellant acknowledges that “[t]he stated motivation or
reason to modify Herskovic is ‘to match an irregular or angled boarder [sic.]
of the target tissue relative to the longitudinal axis of the stent.’” Appeal Br.
12 (quoting Final Act. 6). Appellant contends that “[t]he Examiner’s
asserted motivation appears to be based on an assumption that the
radioactive seeds of Herskovic need to match the border of the target tissue”
and that “there is no teaching of such a need or requirement in Herskovic.”
Appeal Br. 12.
We disagree with Appellant on this point because Herskovic is
specifically directed to customization of the location of the radioactive
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sources vis-à-vis the tumor, and Herskovic also recognizes that tumor shape
and size may change. See Herskovic ¶¶ 14, 15; see also id. at 71 (“[t]he
position of the radioactive particles relative to the target tissue can be
adjusted”). The Examiner further states “that cancer is not limited to a
boundary perpendicular to an axis of the lumen/duct etc. Boundaries can be
angled or irregular to the lumen axis or on one side thereof.” Ans. 7.
Hence, the Examiner’s rationale for the modification (i.e., “to match an
irregular or angled boarder [sic.] of the target tissue”) does not appear to be
“conclusory” as asserted (Appeal Br. 12), but instead appears to be based on
the actual teachings of Herskovic.
Accordingly, and based on the record presented,4 we are not
persuaded the Examiner erred in rejecting claims 1, 16, and 20 as being
obvious in view of Herskovic. We sustain the rejection.
Claim 4
Claim 4 depends directly from claim 1 and further recites wherein the
various filaments of the stent and the one or more tubular members “are
braided together.” The Examiner relies on paragraph 62 of Herskovic as
teaching such interconnectivity. See Final Act. 5, Ans. 10. To be clear,
paragraph 62 of Herskovic states that a preferred embodiment “comprises
tubular members . . . that are woven into the mesh of an expandable stent.”
Appellant contends that because Herskovic addresses a “woven”

4 We note that Appellant also addresses Herskovic’s “loading method” and
“loading methodology” (Appeal Br. 9, 10), but the claims at issue are
apparatus claims and Appellant is not persuasive that even should
Herskovic’s figures also disclose such methodology, Appellant is still not
persuasive the Examiner erred in relying on Herskovic for the reasons
expressed above.
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arrangement, “the reference fails to teach the tubular members being
braided” as recited. Appeal Br. 13; see also Reply Br. 7.
Appellant contends that a skilled person would understand that the
recited “braiding . . . would necessarily involve the tubular members curving
in a non-parallel manner relative to the longitudinal axis.” Appeal Br. 13;
Reply Br. 7. First, claim 4 is silent as to any requirement of parallelism.
Further, Appellant does not explain why Herskovic’s woven arrangement
would be any different (i.e., “curving in a non-parallel manner”) from
Appellant’s braided requirement. Appellant may be seeking to distinguish
“woven” from “braided,” but does not provide different definitions of these
terms that would explain their distinctiveness. Instead, Appellant’s
Specification appears to consider these terms to be comparable in scope.
This is because Appellant’s Specification states, “[f]or example, stent
filaments may be braided, intertwined, interwoven, weaved, knitted or the
like to form the stent structure.” Spec. 7:17–18. Each of these terms involve
some degree of interlacing or co-mingling. Hence, because Appellant’s
Specification treats these two terms as synonyms, we are not persuaded the
Examiner erred in relying on Herskovic’s disclosure of a “woven”
construction as teaching or suggesting Appellant’s “braided” construction.
We sustain the Examiner’s rejection of claim 4.
Claim 11
Claim 11 depends directly from claim 1 and further recites the
limitation wherein a portion of the “tubular members extends from the inner
stent surface to the outer stent surface.” Appellant contends “there is
nothing in Herskovic teaching or suggesting” this limitation. Appeal Br. 13;
Reply Br. 7. However, Appellant does not address Figures 1 and 2 of
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Herskovic which clearly depict tubular members 12 whose radially inner and
outer surfaces are tangent to the radially inner and outer surfaces of stent 10.
To be clear, as regarding the use of figures in this manner, we have
been instructed by our reviewing court that “we did not mean that things
patent drawings show clearly are to be disregarded.” In re Mraz, 455 F.2d
1069, 1072 (CCPA 1972). Here, unlike Appellant’s usage of Herskovic’s
figures above, it is permissible to rely on such drawings for what they
“clearly” show, but unlike above, Herskovic’s drawings are not sufficient to
show only distances that are the same when the accompanying text states
otherwise. Accordingly, we are not persuaded the Examiner erred in finding
claim 11 obvious in view of Herskovic.

CONCLUSION
In summary:

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–13, 15–
17, 19, 20
103 Herskovic 1–13, 15–17,
19, 20

Overall
Outcome
1–13, 15–17,
19, 20

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