BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Apr 7, 2021

2020003257 (P.T.A.B. Apr. 7, 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.
15/083,245 03/28/2016 Robert Squire 8150BSC0387 5667
121974 7590 04/07/2021
Kacvinsky Daisak Bluni PLLC
2601 Weston Parkway, Suite 103
Cary, NC 27513
EXAMINER
SCHWIKER, KATHERINE H
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
04/07/2021 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT SQUIRE, JOEL MUNSINGER, DEREK LARSON,
MARTIN WILLARD, and JOSEPH CONNOLLY
Appeal 2020-003257
Application 15/083,245
Technology Center 3700
Before JUSTIN BUSCH, AMEE A. SHAH, and ROBERT J. SILVERMAN,
Administrative Patent Judges.
BUSCH, 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 1–5, 7–15, and 17–20. We have
jurisdiction 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(a). Appellant identifies the real party in interest as Boston Scientific
Scimed, Inc. Appeal Br. 2.
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Application 15/083,245
2
CLAIMED SUBJECT MATTER
The claimed subject matter relates to systems and methods for
vascular occlusion. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A system for treating a patient, comprising:
an expandable occlusive plug, comprising an elongate
shaft and, disposed at a distal end of the elongate shaft, a flexible
framework at least partially covered by a membrane, wherein at
least a portion of the membrane includes a coating to improve
adhesion of the membrane to a vessel wall, the flexible
framework moveable between a first configuration characterized
by a first diameter and a second configuration characterized by a
second diameter larger than the first diameter;
a pushrod configured to deliver the expandable occlusive
plug within the patient; and
a dissolvable sleeve disposed about the flexible framework
and configured to detachably couple the elongate shaft to the
pushrod and constrain the flexible framework, in the first
configuration.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Himpens US 5,397,331 Mar. 14, 1995
Avellanet
(“Avellanet ’097”)
US 2003/0093097 A1 May 15, 2003
Avellanet (“Avellanet”) US 2003/0093108 A1 May 15, 2003
Porter US 2004/0044391 A1 Mar. 4, 2004
Johnson US 2006/0293741 A1 Dec. 28, 2006
Komlos US 2013/0131701 A1 May 23, 2013
Cragg US 2015/0039019 A1 Feb. 5, 2015

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3
REJECTIONS
Claims 1–5, 7–10, 12–15, 17, and 18 stand rejected under 35 U.S.C.
§ 103 as obvious over Avellanet, Cragg, and Johnson. Final Act. 4–10.
Claim 11 stands rejected under 35 U.S.C. § 103 as being obvious over
Avellanet, Cragg, Johnson, and Avellanet ’097. Final Act. 10–11.
Claim 19 stands rejected under 35 U.S.C. § 103 as being obvious over
Avellanet, Cragg, Johnson, and Porter. Final Act. 11.
Claim 20 stands rejected under 35 U.S.C. § 103 as being obvious over
Avellanet, Cragg, Johnson, Porter, and Avellanet ’097. Final Act. 11–12.
Claims 1–5, 7–10, and 12–15 stand rejected under 35 U.S.C. § 103 as
being obvious over Himpens, Komlos, and Johnson. Final Act. 12–16.

ANALYSIS
REJECTIONS INVOLVING MODIFYING AVELLANET WITH JOHNSON
The Examiner rejects claims 1–5, 7–10, 12–15, 17, and 18 as obvious
over Avellanet, Cragg, and Johnson. Final Act. 4–10. Appellant argues the
claims as a group. See Appeal Br. 9–12; Reply Br. 5–7. We select claim 1
as representative of these claims. See 37 C.F.R. § 41.37(c)(1)(iv).
Specifically, the Examiner finds Avellanet teaches or suggests the
pushrod and the expandable occlusive plug recited in representative claim 1,
including the particular details of the plug except that Avellanet “is silent
regarding [at] least a portion of the [plug’s] membrane includes a coating to
improve adhesion of the membrane to a vessel wall.” Final Act. 4 (citing
Avellanet ¶¶ 28, 29, 32, Figs. 1–6). The Examiner finds Cragg teaches the
recited coating, and the Examiner provides a reason for combining Cragg’s
coating with Avellanet’s membrane. Final Act. 4–5 (citing Cragg ¶¶ 28,
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Application 15/083,245
4
218). Appellant does not dispute these findings. See generally Appeal
Br. 9–12; Reply Br. 5–7.
Of particular relevance to Appellant’s arguments regarding this
rejection, the Examiner finds Avellanet, as modified by Cragg, “is silent
regarding a dissolvable sleeve disposed about the flexible framework and
configured to detachably couple the elongate shaft to the pushrod and
constrain the flexible framework, in the first configuration.” Final Act. 5.
However, the Examiner finds Johnson, which relates to similar technology
for delivering implants, teaches or suggest the dissolvable sleeve recited in
representative claim 1. Final Act. 5. More specifically, the Examiner finds
that, similar to Avellanet, Johnson teaches:
a system for treating a patient comprising an implant 40' having
a flexible framework moveable between a first collapsed
configuration and a second expanded configuration (see ¶0037),
a push rod 16' configured to deliver the implant 40' (see ¶0037
and fig. 4), a dissolvable sleeve 46' (not shown in fig. 4, see
sleeve 46 in fig. 2A) disposed about the flexible framework (see
¶0037) and configured to detachably couple the implant 40' to
the pushrod 16' and constrain the flexible framework, in the first
configuration (see ¶0037); the sleeve 46' sized to hold the
flexible framework in the first configuration and configured to
dissolve, degrade or erode when placed in a blood vessel of a
patient (see ¶0037).
Final Act. 5.
In other words, the Examiner finds Johnson teaches a dissolvable
sleeve in a similar system that is designed to fit around an implant device
having a flexible framework and to secure the implant device in a first,
compressed, configuration. See Final Act. 5–6 (explaining that the proposed
modification to Avellanet involves adding Johnson’s dissolvable sleeve so
that the sleeve covers Avellanet’s implant and a portion of the pushrod and,
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5
because Avellanet’s “elongate shaft is part of the implant and directly
connected to the portion of the implant covered by the [added] dissolvable
sleeve, therefore the [added] dissolvable sleeve couples the elongate shaft to
the push rod.”). The Examiner determines a person of ordinary skill in the
art would have modified Avellanet with Johnson’s dissolvable sleeve in
order “to keep the implant in the collapsed configuration after it has been
extended out of the catheter to allow more time and maneuverability of the
implant before expansion to ensure that it is in the proper place.” Final
Act. 5–6 (citing Johnson ¶ 37).
Avellanet discloses an aneurysm neck cover having a support element
connected to two expandable sealing members, the sealing members expand
when the aneurysm neck cover is deployed. Avellanet, Abstract; see
Figs. 1–6. Figure 2, which depicts aneurysm neck cover 10 in a collapsed
configuration within lumen 24 of sheath 14, is reproduced below:

Avellanet, Fig. 2 (depicting “an enlarged, sectional view of the
aneurysm neck cover [10] in a collapsed configuration within a lumen [24]
of the sheath [14] and attached to a distal end of the deployment catheter
[12],” Avellanet ¶ 19). Avellanet further teaches lumen 24 of “sheath 14 is
sufficiently small enough so that the aneurysm neck cover 10 is compressed
to a collapsed configuration.” Avellanet ¶ 27.
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Avellanet’s Figures 4 through 6 depict deploying aneurysm neck
cover 10 within the aneurysm. See Avellanet ¶¶ 34–36, Figs. 4–6.
Maintaining aneurysm neck cover 10 in a collapsed configuration by being
disposed within sheath 14 allows “aneurysm neck cover 10 to be inserted
and transported through narrow vasculature of the human body.” Avellanet
¶ 34. In addition to the elements depicted in Figures 1 through 3, Avellanet
positions a delivery catheter in the blood vessel to help guide deployment
catheter 12 to the aneurysm. Avellanet ¶ 34. Avellanet positions sheath
14’s distal end at the aneurysm mouth, then moves the deployment catheter
distally causing aneurysm neck cover 10 to begin exiting sheath 14.
Avellanet ¶ 35.
Johnson discloses systems and techniques that include carrying an
implant (i.e., a stent) through a blood vessel in a compressed configuration
using a sheath and deploying the implant in and expanded configuration at
the desired location. Johnson, ¶¶ 29, 37, Abstract. In one embodiment that
uses a dissolvable sheath, which the Examiner finds teaches the claimed
dissolvable sleeve, the implant deploys to the expanded configuration when
the sleeve dissolves. Johnson ¶ 37.
With respect to this ground of rejection, Appellant argues only that
there is no motivation or suggestion in Avellanet or Johnson to combine
Johnson’s sleeve with Avellanet’s neck cover. Appeal Br. 10; see Appeal
Br. 11–12; Reply Br. 5–7. More specifically, Appellant asserts Johnson’s
dissolvable sleeve could not be formed over Avellanet’s aneurysm neck
cover in its collapsed configuration because Avellanet’s “aneurysm neck
cover 10 fills the lumen 24 and is mostly spaced away from the catheter 12
rather than against the wall of the deployment catheter 12.” Appeal Br. 11;
see Reply Br. 6 (arguing Avellanet discloses that aneurysm neck cover 10
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7
fills lumen 24 of sheath 14 and sealing members 30, 32 must be spaced apart
from the deployment catheter because lumen 24 must be small enough to
compress aneurysm neck cover 10). Appellant contends that, because
Johnson does not suggest how to form the dissolvable sleeve over
Avellanet’s aneurysm neck cover in its collapsed configuration, the
proposed modified device would not operate for its intended purpose.
Appeal Br. 11. Appellant also asserts using Johnson’s dissolvable sleeve to
restrain Avellanet’s aneurysm neck cover “would be needlessly redundant
with” Avellanet’s sheath. Appeal Br. 11; see Reply Br. 7 (arguing “Johnson
does not teach or suggest a device including both a dissolvable coating 46'
and a sheath 55' for constraining the stent 40'”).
The Examiner provides a specific reason a person of ordinary skill in
the art would have modified Avellanet with Johnson’s dissolvable sleeve.
Specifically, the Examiner states that the modification would “keep the
implant in the collapsed configuration after it has been extended out of the
catheter to allow more time and maneuverability of the implant before
expansion to ensure that it is in the proper place.” Final Act. 5–6 (citing
Johnson ¶ 37). This explanation also explains why it would not be
redundant to modify Avellanet with Johnson’s teachings. Avellanet’s sheath
allows for positioning the deployment catheter at the aneurysm mouth and
Johnson’s dissolvable sleeve provides more time to ensure the implant is
properly placed prior to expansion. See Johnson ¶ 37 (explaining that using
a dissolvable sleeve still requires a guide catheter to “cannulate a vessel of
the heart” so that the stent (constrained by the dissolvable sleeve) can be
advanced beyond the guide catheter to the implant deployment position).
To the extent Johnson’s sleeve would otherwise be redundant with
Avellanet’s sheath and with respect to Appellant’s arguments that modifying
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8
Avellanet would not work due to the size and spacing of the neck cover and
lumen, we disagree. “[I]t is not necessary that the inventions of the
references be physically combinable to render obvious the invention under
review.” In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference; . . . [r]ather,
the test is what the combined teachings of those references would have
suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413,
425 (CCPA 1981) (citations omitted).
As the Examiner explains, “the aneurysm neck cover as modified with
the dissolvable sleeve of Johnson will still fit in the sheath 14.” Ans. 4. We
agree with the Examiner that the combined teachings of Avellanet and
Johnson would have suggested to an ordinarily skilled artisan the
Examiner’s proposed modification. We understand the Examiner’s rejection
as applying Johnson’s teachings to result in an aneurysm neck cover held in
its collapsed configuration by the dissolvable sleeve such that the collapsed
neck cover and sleeve would fit within Avellanet’s sheath. This would be
similar to Johnson’s disclosure that the implant and dissolvable sleeve fit
within a guide catheter. See Johnson ¶ 37. Because Appellant’s argument is
directed to a bodily incorporation of the references, and not directed to the
combined teachings of the references, we are unpersuaded of Examiner
error.
Moreover, we see no evidence on this record to indicate that a
modification allowing room for the dissolvable sleeve would either be
beyond the abilities of an ordinarily skilled artisan or change the principle of
Avellanet’s intended purpose. An obviousness analysis “need not seek out
precise teachings directed to the specific subject matter of the challenged
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9
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007). “A person of ordinary skill is also a person
of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421. In fact,
Johnson discloses that various techniques were known in the art for
containing and restraining implants in a collapsed configuration and suggests
such techniques generally are fungible. Johnson ¶ 29 (“sheath 46 may have
other configurations and removal features as are known in the art” such as,
for example “sheath 46 may be slidable over the catheter 43 [or] sheath 46 is
made from a dissolvable, biocompatible coating such as sugar disposed over
the stent 40 but not necessarily extending over the length of the catheter
43”). Accordingly, the evidence of record indicates that a person of ordinary
skill in the art would know how to implement different techniques or
elements for maintaining an implant in a collapsed configuration until
deployment, and how to modify the necessary dimensions to ensure proper
design of the modified system.
Appellant also asserts the proposed modification “is in direct
opposition” to how Avellanet’s aneurysm neck cover operates. Reply Br. 5.
Specifically, Appellant contends “it is desirable that the aneurysm neck
cover 10 expands immediately upon exiting the sheath 14.” Reply Br. 5; see
Reply Br. 6 (arguing Avellanet discloses that “it is desirable for the sealing
members 30, 32 of the aneurysm neck cover 10 to immediately expand upon
exiting the sheath 14 at the mouth of an aneurysm 12 for sealing purposes
rather than for example a delayed expansion after the coating 46' is
dissolved”). Appellant quotes Avellanet’s paragraph 35 as supporting this
assertion. Reply Br. 5.
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10
We disagree. The relevant disclosure states that, “[w]ithout the sheath
14 maintaining the aneurysm neck cover 10 in a collapsed configuration, the
first sealing member 30 expands within the aneurysm 42.” Avellanet ¶ 35.
This statement discloses that sealing member 30, which is a part of
aneurysm neck cover 10, expands when sealing member 30 is no longer
within sheath 14. However, we disagree that this disclosure indicates a
preference or desirability that expansion occurs immediately upon exiting
sheath 14.
In Avellanet, there is no choice when expansion occurs because
sheath 14 is the only element constraining sealing member 30 in its
collapsed configuration. Therefore, when sealing member 30 is no longer
within sheath 14, it is free to expand. Avellanet, however, does not opine on
whether this immediate expansion is desired. Moreover the Examiner’s
rationale for modifying Avellanet—“to allow more time and
maneuverability of the implant before expansion to ensure that it is in the
proper place”—provides a benefit that may offset any desirability, which is
not explicitly stated in Avellanet, to deploy the implant immediately upon
exiting sheath 14. Thus, even to the extent a person of ordinary skill in the
art would have appreciated any benefit from expanding the implant
immediately upon exiting the sheath, such recognition does not undermine
the Examiner’s rationale in this case. In re Urbanski, 809 F.3d 1237, 1243
(Fed. Cir. 2016) (“On this record, the Board properly found that one of
ordinary skill would have been motivated to pursue the desirable properties
taught by Wong, even at the expense of foregoing the benefit taught by
Gross.”); Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir.
2006) (“[A] given course of action often has simultaneous advantages and
disadvantages, and this does not necessarily obviate motivation to
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11
combine.”); Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8
(Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense
of another benefit, however, should not nullify its use as a basis to modify
the disclosure of one reference with the teachings of another. Instead, the
benefits, both lost and gained, should be weighed against one another.”)
Moreover, in the Examiner’s proposed combination, Johnson’s
dissolvable sleeve or sheath functions to constrain aneurysm neck cover 10
in its collapsed configuration. In the proposed system, aneurysm neck cover
10 would expand immediately upon dissolution of the dissolvable sleeve or
sheath. In other words, the proposed modification would maintain
Avellanet’s alleged, but unstated, desire to expand immediately upon exiting
the element constraining aneurysm neck cover 10 because the combination’s
dissolvable sleeve or sheath is the constraining element.
For these reasons, we sustain the Examiner’s rejection of
representative claim 1, as well as grouped claims 2–5, 7–10, 12–15, 17, and
18 as obvious over Avellanet, Cragg, and Johnson. The Examiner rejects:
claim 11 as obvious over Avellanet, Cragg, Johnson, and Avellanet ’097;
claim 19 as obvious over Avellanet, Cragg, Johnson, and Porter; and claim
20 as obvious over Avellanet, Cragg, Johnson, Porter, and Avellanet ’097.
Final Act. 10–12. Appellant argues only that the additionally cited
references do not cure the deficiencies of Avellanet, Cragg, and Johnson
asserted regarding claim 1. Appeal Br. 14–15; Reply Br. 8–9. Because we
do not find any deficiency with respect the Examiner’s combination of
Avellanet, Cragg, and Johnson, and because Appellant presents no separate
substantive arguments with respect to claims 11, 19, and 20, we also sustain
the Examiner’s rejections of claims 11, 19, and 20.
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12
REJECTION INVOLVING MODIFYING HIMPENS WITH JOHNSON
The Examiner rejects claims 1–5, 7–10, and 12–15 as obvious over
Himpens, Komlos, and Johnson. Final Act. 12–16. Appellant argues the
claims as a group. See Appeal Br. 12–14; Reply Br. 8. We select claim 1 as
representative.
Specifically, the Examiner finds Himpens teaches or suggests the
pushrod and the expandable occlusive plug recited in representative claim 1,
including the particular details of the plug except that Himpens “is silent
regarding [at] least a portion of the [plug’s] membrane includes a coating to
improve adhesion of the membrane to a vessel wall.” Final Act. 13 (citing
Himpens 1:20–31, 2:20–31, 4:66–5:34, 5:47–58, 6:1–17, Figs. 3–9). The
Examiner finds Komlos teaches the recited coating, and the Examiner
provides a reason for combining Komlos’s coating with Avellanet’s
membrane. Final Act. 13 (citing Komlos ¶ 315). Appellant does not dispute
these findings. See generally Appeal Br. 12–14; Reply Br. 8.
Of particular relevance to Appellant’s arguments regarding this
rejection, the Examiner finds Himpens, as modified by Komlos, “is silent
regarding a dissolvable sleeve disposed about the flexible framework and
configured to detachably couple the elongate shaft to the pushrod and
constrain the flexible framework, in the first configuration.” Final Act. 13.
However, the Examiner finds Johnson, which relates to similar technology
for delivering implants, teaches or suggest the dissolvable sleeve recited in
representative claim 1. Final Act. 13–14. More specifically, the Examiner
finds that, similar to Himpens, Johnson teaches:
a system for treating a patient comprising an implant 40' having
a flexible framework moveable between a first collapsed
configuration and a second expanded configuration (see ¶0037),
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13
a push rod 16' configured to deliver the implant 40' (see ¶0037
and fig. 4), a dissolvable sleeve 46' (not shown in fig. 4, see
sleeve 46 in fig. 2A) disposed about the flexible framework (see
¶0037) and configured to detachably couple the implant 40' to
the pushrod 16' and constrain the flexible framework, in the first
configuration (see ¶0037).
Final Act. 13–14.
In other words, the Examiner finds Johnson teaches a dissolvable
sleeve in a similar system that is designed to fit around an implant device
having a flexible framework and to secure the implant device in a first,
compressed, configuration. See Final Act. 14 (explaining that the proposed
modification to Himpens involves adding Johnson’s dissolvable sleeve so
that the sleeve covers Himpens’s implant and part of the pushrod and,
because Himpens’s “elongate shaft is part of the implant and directly
connected to the portion of the implant covered by the [added] dissolvable
sleeve, therefore the [added] dissolvable sleeve couples the elongate shaft to
the push rod.”). The Examiner determines a person of ordinary skill in the
art would have modified Himpens with Johnson’s dissolvable sleeve in order
“to keep the implant in the collapsed configuration after it has been extended
out of the catheter to allow more time and maneuverability of the implant
before expansion to ensure that it is in the proper place.” Final Act. 14
(citing Johnson ¶ 37).
With respect to this ground of rejection, Appellant argues only that the
“proposed combination would render the device of Himpens inoperable for
its intended purpose.” Appeal Br. 13; see Appeal Br. 13–15; Reply Br. 8.
More specifically, Appellant first asserts that Johnson’s dissolvable sleeve
could not be formed over Himpens’s implant device because then the
implant device could not “be inserted into and folded by the dissolvable”
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sleeve because “Johnson does not suggest that the dissolvable coating 46'
(e.g., a sugar coating) would have the material strength to withstand such
folding by the trocar sheath 23.” Appeal Br. 13 (citation omitted); see Reply
Br. 8 (arguing that, in order to use Johnson’s dissolvable sleeve with
Himpens’s implant, the dissolvable sleeve “would need to establish and
maintain the folded layers and stiffener wires 14 of supporting device 12
before insertion into the trocar sheath 23” but “Johnson does not suggest that
the dissolvable” sleeve covering a stent “would have the material strength to
establish and maintain the folded layers and stiffener wires 14 of the
supporting device 12”).
Appellant does not support the assertion that Johnson’s dissolvable
sleeve lacks the necessary material strength to constrain Himpens’s implant
with any persuasive reasoning or evidence. It is well settled that mere
attorney arguments and conclusory statements, which are unsupported by
factual evidence, are entitled to little probative value. In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997); see also In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) (attorney argument is not evidence). Accordingly, we
are not apprised of Examiner error.
Appellant next contends that “Himpens does not disclose that the
supporting device 12 could or is intended to be restrained in such a way.”
Appeal Br. 13.
The Examiner correctly notes that “Himpens is not required to . . .
expressly teach this in order to be modified with Johnson” because the
rejection is based on what the Himpens and Johnson’s combined disclosures
would have taught or suggested to a person of ordinary skill in the art.
Ans. 6. The Examiner finds Himpens does not provide any disclosure that
would teach away from the proposed combination or otherwise suggest that
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the proposed combination would not work or have been an obvious
modification to a person of ordinary skill in the art. The test for obviousness
is not whether the claimed invention is expressly suggested in any one or all
of the references, but whether the claimed subject matter would have been
obvious to those of ordinary skill in the art in light of the combined
teachings of those references. See Keller, 642 F.2d at 425. Moreover, what
a reference teaches or suggests to a person of ordinary skill is not limited to
what a reference specifically “talks about” or what is specifically
“mentioned” or “written” in the reference; rather the disclosures must be
examined in the context of the knowledge, skill, and reasoning ability of a
skilled artisan. Syntex (U.S.A.) LLC v. Apotex, Inc. 407 F.3d 1371, 1380
(Fed. Cir. 2005).
Appellant also asserts modifying Himpens’s system as proposed
would result in the gapped space in the trocar sheath coring out “rather than
percutaneously pass[ing] through the abdominal wall, rendering the device
of Himpens inoperable.” Appeal Br. 13–14. In response, the Examiner
finds Himpens discloses percutaneously passing the trocar sheath through
the abdominal wall prior to introducing the implant into the trocar sheath.
Ans. 7 (citing Himpens 5:62–6:16). The Examiner explains that this means
Himpens’s trocar sheath is empty when passing through the abdominal wall
and, thus, the proposed modification would not alter how the trocar sheath
functions. Ans. 7.
We agree with and adopt these findings. Himpens explicitly discloses
“a trocar sheath 23 is percutaneously passed through the abdominal wall,”
then the implant is collapsed to allow the implant to pass through the trocar
sheath and into the abdominal cavity. Himpens 5:64–6:11.
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Finally, Appellant argues Johnson’s dissolvable sleeve “would be
needlessly redundant in view of the folding trocar sheath 23” in Himpens, so
a person of ordinary skill in the art would not make the proposed
combination. Appeal Br. 14. The Examiner provides a rationale for
modifying Himpens with Johnson’s dissolvable sleeve—namely, “to keep
the implant in the collapsed configuration after it has been extended out of
the catheter to allow more time and maneuverability of the implant to ensure
that it is in the proper place.” Final Act. 14 (citing Johnson ¶ 37).
Contrary to Appellant’s assertion, this rationale explains why it would
not be redundant to modify Himpens with Johnson’s teachings. Himpens’s
trocar sheath percutaneously passes through the abdominal wall, positioning
the distal end at the location where the implant will be deployed. Himpens
5:64–6:11. Modifying Himpens with Johnson’s dissolvable sleeve provides
more time to ensure the implant is properly placed prior to expansion. See
Johnson ¶ 37 (explaining that using a dissolvable sleeve still requires a guide
catheter to “cannulate a vessel of the heart” so that the stent (constrained by
the dissolvable sleeve) can be advanced beyond the guide catheter to the
implant deployment position).
For these reasons, we sustain the Examiner’s rejection of
representative claim 1, as well as grouped claims 2–5, 7–10, and 12–15 as
obvious over Himpens, Komlos, and Johnson.
CONCLUSION
The Examiner’s rejections are AFFIRMED.
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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 7–10,
12–15, 17, 18
103 Avellanet, Cragg, Johnson 1–5, 7–10,
12–15, 17, 18

11 103 Avellanet, Cragg, Johnson,
Avellanet ’097
11
19 103 Avellanet, Cragg, Johnson,
Porter
19
20 103 Avellanet, Cragg, Johnson,
Porter, Avellanet ’097
20
1–5, 7–10,
12–15
103 Himpens, Komlos, Johnson 1–5, 7–10,
12–15

Overall
Outcome
1–5, 7–15,
17–20

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