BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Nov 12, 2020

15237147 - (D) (P.T.A.B. Nov. 12, 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.
15/237,147 08/15/2016 JOHN A. HINGSTON 2001.1324101 1060
11050 7590 11/12/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
PREBILIC, PAUL B
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
11/12/2020 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 JOHN A. HINGSTON and CLAUDE O. CLERC

Appeal 2020-000413
Application 15/237,147
Technology Center 3700
____________

Before MICHAEL L. HOELTER, BRETT C. MARTIN, 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 1–3, 5–8, 21, and 23–29, which
constitute all the claims pending in this application. 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. 4.
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CLAIMED SUBJECT MATTER
The disclosed subject matter “pertains to medical devices, and
methods for preparing medical devices.” Spec. 1:10–11. Apparatus claims
1, 21, and 27 are independent. Claim 1 is illustrative of the claims on appeal
and is reproduced below.
1. A stent, comprising:
an expandable framework;
a plurality of polymeric tubular members disposed along
the expandable framework, each of the plurality of tubular
members including a lumen extending therein; and
a silicone coating;
wherein the coating is simultaneously applied directly to
both an outer surface of the plurality of tubular members and an
outer surface of the expandable framework;
wherein the plurality of tubular members and the
expandable framework are embedded in the coating.
EVIDENCE
Name Reference Date
Nolting et al. (“Nolting”) US 6,488,701 B1 Dec. 3, 2002
Neary US 2008/0071360 A1 Mar. 20, 2008
Burnside et al. (“Burnside”) US 8,062,351 B2 Nov. 22, 2011
Herskovic WO 2014/031950 A1 Feb. 27, 2014
REJECTIONS
Claim 1–3, 5, 7, 8, 21, and 24–26 are rejected under 35 U.S.C. § 103
as unpatentable over Herskovic and Nolting or Neary.
Claims 6, 23, and 27–29 are rejected under 35 U.S.C. § 103 as
unpatentable over Herskovic, Nolting or Neary, and Burnside.

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ANALYSIS
The rejection of claims 1–3, 5, 7, 8, 21, and 24–26
as unpatentable over Herskovic and Nolting or Neary
Appellant presents separate arguments for claims 1, 3, and 21. See
Appeal Br. 6–12. We select these three claims for review, with the
remaining claims (i.e., dependent claims 2, 5, 7, 8, and 24–26) standing or
falling with their respective parent claim. See 37 C.F.R. § 41.37(c)(1)(iv).
Claim 1
Claim 1 recites a stent comprising a framework and tubular members.
Claim 1 also recites a coating that “is simultaneously applied” to the outer
surfaces of the framework and tubular members “wherein the plurality of
tubular members and the expandable framework are embedded in the
coating.” The Examiner relies on Herskovic for disclosing a stent having the
recited framework and tubular members, but relies on either Nolting or
Neary for teaching that it is “known to encapsulate similar stents as a way to
prevent stent contact with tissues.” Final Act. 3. The Examiner thus reasons
that it would have been obvious to a skilled artisan “to coat the Herskovic
stent and tube structure with an encapsulating coating [of] Neary or Nolting
et al as a way to prevent the harmful effects of stent [metals] materials
contacting the tissue of the vessel.” Final Act. 4; see also Ans. 5.
Appellant contends the Examiner engaged in “arbitrarily handpicking
the rationale from Nolting/Neary and applying to Herskovic (whose
teachings have nothing to do with stent coatings) [which] is clearly
erroneous.” Appeal Br. 8. We disagree with this assessment by Appellant
because, instead, we have been instructed by our reviewing court that
“picking and choosing may be entirely proper in the making of a 103,
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obviousness rejection, [provided Appellant is] afforded an opportunity to
rebut with objective evidence any inference of obviousness which may
arise.” In re Arkley, 455 F.2d 586, 587–88 (CCPA 1972). See also KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“a patent composed of
several elements is not proved obvious merely by demonstrating that each of
its elements was, independently, known in the prior art. Although . . . it can
be important to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does”). In view of the above, we are not persuaded
the Examiner failed to provide a reason for the stated combination of
selected teachings, or that Appellant is being denied an opportunity to rebut.
Addressing Nolting, Appellant contends that “Nolting only appears to
teach coating the stent itself” and that a skilled person “applying the coating
of Nolting to the stent of Herskovic . . . would not expect the coating to be
applied to the outer surface of the plurality of tubular members.” Appeal Br.
8; see also Reply Br. 2. To be clear, Herskovic teaches that the relied-upon
tubular members can be “embedded within the stent itself,” such as by
weaving. Herskovic ¶ 63. Nolting teaches, “[t]he stent is coated via either a
dipping process or a spraying process.” Nolting 9:28–29. In view of the
above, Appellant does not explain how Herskovic’s woven device, which is
dip or spray coated, would result in a coating applied only to the stent and
not also to the interlaced tubular members.
Appellant also contends, “Nolting is silent with respect to the effect
on the structural integrity of the stent” and that “Nolting cannot teach or
suggest improving the structural integrity between those components of
Herskovic.” Appeal Br. 8; see also Reply Br. 2. Appellant makes similar
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arguments regarding Neary, i.e., “Neary fails to teach that adding a coating
to the stent of Herskovic will provide ‘external support’ to the stent.”
Appeal Br. 9. However, with respect to claim 1, neither Nolting nor Neary
were relied upon for enhancing the “structural integrity” of the stent or for
providing “external support” to the stent, but instead, were relied upon for
teaching the application of a coating. See Final Act. 3–4; see also Ans. 5
(“Nolting was utilized to teach coating to encapsulate similar stents with
such a coating.”). This is primarily because claim 1 is silent as to any
limitation directed to the coating providing structural support to the stent.
Appellant also challenges the Examiner’s reason to combine
Herskovic with either Nolting or Neary stating that neither “Nolting and/or
Neary teach that it is harmful for stent ‘material’ to contact the tissue of a
vessel.” Appeal Br. 9. The Examiner explains that “the rationale to
combine prior art references need not come from the primary reference or
even from the secondary references.” Ans. 3. This is consistent with
guidance to the effect that “[t]he obviousness analysis cannot be confined by
. . . the explicit content of issued patents” and that “it can be important to
identify a reason that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed new invention
does.” KSR, 550 U.S. at 418–19; see also Ans. 5. Here, Appellant is not
disputing that the Examiner failed to provide a reason for the combination
(or even perhaps that the reason was faulty), but instead, Appellant contends
that the Examiner erred because the reason provided was not expressed in
Nolting or Neary. This is not persuasive of Examiner error. But see Nolting
4:46–63 (addressing the minimization of “thrombogenic potential, vessel
reocclusion and tissue prolapse following deployment”).
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Appellant further addresses the claim 1 recitation that the “coating” be
“a silicone coating.” Appeal Br. 10. Appellant contends that “[n]either
Nolting nor Neary teach such a construction.” Id. The Examiner, however,
states that “Herskovic disclose silicon coating on the insides of the tubes
(see paragraph 74), but Nolting also teaches coating the stent with silicone as
well.” Ans. 6. Indeed, Nolting teaches, “Suitable material for the coating
includes but is not limited to polyurethane, fluorinated ethylene propylene,
and silicone.” Nolting 7:52–54. Appellant’s contention is not persuasive in
view these teachings.
Appellant also addresses the limitation that the coating be
“simultaneously applied.” Appeal Br. 10. However, the Examiner deemed
this recited application is a “product-by-process limitation” and as such, the
limitation “does not clearly structurally distinguish the claimed invention
from a stent that has the coatings applied sequentially.” Final Act. 3; see
also Ans. 6. Appellant does not appraise us of Examiner error on this point.
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claim 1 (and dependent claims 2, 5, 7, and 8)
as being obvious over Herskovic and Nolting or Neary.
Claim 3
Claim 3 depends from claim 1 and additionally recites, “wherein the
coating attaches the plurality of tubular members to the expandable
framework.” Appellant contends that because Herskovic already teaches
“that the tubular members are attached to the stent,” “there is no rationale
reason to look to Nolting or Neary as a means for attaching tubular members
to a stent.” Appeal Br. 12; see also Reply Br. 3.
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Indeed, Herskovic teaches interweaving of the tubular members and
the stent (see Herskovic ¶ 63), but this does not mean that Herskovic’s
manner of attachment cannot be improved upon. To be specific, the
Examiner “asserts that ordinary artisans commonly seek ways to improve
their inventions and this is behind the motivation to innovate in the first
place.” Ans. 7. Further, as explained above, the teachings of Nolting and
Neary already make it “known to encapsulate similar stents” with a coating
(Final Act. 3) and once encapsulated, Appellant does not explain how such
coating fails to improve or enhance the attachment or securement of the
members to each other. Nolting and Neary suggest such an interrelationship
between coating and securing because Nolting’s Background discusses the
need to maintain “radial strength” and how others “coat[] a stent with
vulcanizing silicone rubber adhesive and curing the adhesive.” Nolting
2:43, 4:14–15; see also Nolting 5:3–4 (it being an object of the invention “to
provide an improved stent-graft assembly with ample radial strength”).
Neary places similar importance on strength discussing a coating that is used
“when needed to improve adhesion” (albeit here, adhesion between a drug
and a stent framework). Neary ¶ 30. In short, Appellant fails to indicate
how a coating, such as those discussed in Nolting and/or Neary, would fail
to further “attach[] the plurality of tubular members to the expandable
framework” as recited.2

2 We note that in Appellant’s Reply Brief, Appellant contends that Nolting
“does not teach or suggest a coating ‘simultaneously applied.’” Reply Br. 3.
Although this “simultaneous” argument was not previously addressed with
respect to claim 3 in the Appeal Brief, it is addressed with respect to parent
claim 1. As noted above, we do not find such contention persuasive.
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Accordingly, and based on the record presented, we are not persuaded
the Examiner improperly rejected claim 3 as being obvious over Herskovic
and Nolting or Neary. We sustain the Examiner’s rejection of claim 3.
Claim 21
Independent claim 21, like claim 3 above, includes the same
limitation, i.e., “wherein the coating attaches the plurality of tubular
members to the expandable framework.” Appellant contends that because
there is no deficiency in Herskovic’s manner of attachment, a skilled person
would not “seek out a different and/or allegedly improved means of
attachment.” Appeal Br. 11. To be clear, the Examiner nowhere states that
Herskovic is deficient and thus a need to “seek out a different . . . means of
attachment.” Instead, the Examiner states (similar to claim 3 above) “that
ordinary artisans commonly seek ways to improve their inventions and this
is behind the motivation to innovate in the first place.” Ans. 6. In view of
the above, Appellant fails to explain how the Examiner’s motivation to
combine is faulty or how the Examiner erred in rejecting claim 21 (and
dependent claims 24–26) as being obvious over Herskovic and Nolting or
Neary.
Appellant additionally argues that “the Examiner has exercised an
inventive leap, not supported by the prior art, but rather based upon the
Appellant’s disclosure.” Reply Br. 4. However, Appellant does not identify
where the Examiner’s reasoning and/or rationales were gleaned solely from
Appellant’s disclosure, and not, instead, from the cited art or otherwise
based upon the abilities of one skilled in the art. See In re McLaughlin, 443
F.2d 1392, 1395 (CCPA 1971). See also Ans. 4.
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The rejection of claims 6, 23, and 27–29
as unpatentable over Herskovic, Nolting or Neary, and Burnside
Appellant separately argues claim 6 and claim 23, and also separately
argues claims 27–29 together. See Appeal Br. 6–17. We address each such
grouping separately.
Claim 6
Claim 6 depends (indirectly) from claim 1 and includes the additional
limitation, “wherein the plurality of tubular members are helically wound
around the inner surface of the expandable framework.” The Examiner
relies on Burnside for such a helical disclosure and provides a reason for the
inclusion thereof.3 See Final Act. 4–5, see also Ans. 8.
Appellant contends that the helically-wound components “of Burnside
are not separate tubular components,” but instead are “filaments which are
braided together to define the self-expanding stent structure.” Appeal Br.
13. Hence, according to Appellant, any combination of Burnside with
Herskovic “would be to the stent of Herskovic in which the expanded stent
framework itself is made from tubular filaments.” Appeal Br. 13. Appellant
concludes that this combination “would result, at best, in a stent that is
constructed from helically-oriented tubular elements.” Appeal Br. 14.
However, the Examiner is not eliminating Herskovic’s framework members
altogether as Appellant seems to suggest, in favor of only tubular members.
Instead, the Examiner is employing Burnside to teach that tubular members

3 We note Herskovic’s teaching that the tubular members can be “attached to
the stent on the outside or inside walls of the stent.” Herskovic ¶ 63; see
also Ans. 6. This likely prompted the Examiner to only state that
“Herskovic fails to disclose the helical orientation for the tubular elements.”
Final Act. 4.
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can also be helically wound, and thus applies such teachings to the tubular
members of Herskovic’s stent. To be clear, the Examiner’s stated reason for
the combination is “to orient the tubular elements helically in order to
provide a more integrated structure of tubes and frame elements such that
the tubes could function as frame elements.” Final Act. 5 (emphasis added);
see also Ans. 8. We do not discern any error in the Examiner’s analysis.
Accordingly, we affirm the Examiner’s rejection of claim 6.
Claim 23
Claim 23 depends from independent claim 21 and recites the same
limitation as addressed above with respect to claim 6. Appellant’s
arguments are also a repeat of those presented above with respect to claim 6.
See Appeal Br. 14. Accordingly, we are not persuaded the Examiner erred
by the additional reliance on Burnside, or the reasons expressed for such
reliance, to reject claim 23. We affirm the Examiner’s rejection thereof.
Claims 27–29
Appellant separately argues claim 27 stating that claims 28 and 29
“are patentable” because they “depend from patentable claim 27.” Appeal
Br. 17. We select claim 27 for review.
Claim 27 recites similar language as discussed above with respect to
claims 6 and 23, i.e., “tubular members disposed helically along a surface of
the expandable framework.” Appellant repeats the contentions previously
asserted, which are not persuasive for reasons already expressed. See
Appeal Br. 15–16. Claim 27 additionally recites a coating that “is
simultaneously applied” as also found in claim 1 and which is discussed
above. We do not find error in the Examiner’s assessment of this limitation
as a “product-by-process limitation.” Final Act. 3; see also Ans. 8 (“the
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Examiner asserts that claims 27–29 are also unpatentable for the reasons that
the Examiner put forth earlier”). Appellant also asserts the Examiner relied
upon “improper hindsight” when rendering this rejection. Reply Br. 5; see
also id. at 4. However, as with respect to claim 21 above, Appellant renders
this assertion without explaining how the Examiner’s reasoning and/or
rationales were gleaned solely from Appellant’s disclosure and not, instead,
from the cited art or otherwise based upon the abilities of one skilled in the
art. We sustain the Examiner’s rejection of claims 27–29.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 5, 7, 8,
21, 24–26
103 Herskovic,
Nolting, Neary
1–3, 5, 7, 8,
21, 24–26

6, 23, 27–29 103 Herskovic,
Nolting, Neary,
Burnside
6, 23, 27–29
Overall
Outcome
1–3, 5–8, 21,
23–29

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