Ex Parte Schwager et al

Patent Trial and Appeal Board

Oct 15, 2018

13779683 (P.T.A.B. Oct. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/779,683 02/27/2013
62614 7590 10/17/2018
BAKER BOTTS L.L.P.
30 ROCKEFELLER PLAZA
44th Floor
NEW YORK, NY 10112-4498
FIRST NAMED INVENTOR
Michael Schwager
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
003168.1559 7800
EXAMINER
TRAVERS, MATTHEW P
ART UNIT PAPER NUMBER
3726
NOTIFICATION DATE DELIVERY MODE
10/17/2018 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):
DLNYDOCKET@BAKERBOTTS.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL SCHWAGER,
MAR TIN FREI, and
SUK-WOO HA
Appeal2018-000319
Application 13/779,683
Technology Center 3700
Before MICHAEL L. HOELTER, BENJAMIN D. M. WOOD, and
FREDERICK C. LANEY, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from the
Examiner's Final Rejection of claims 36-46. App. Br. 1, 6. Claims 1-35
have been cancelled. App. Br. 6; see also Amendment dated January 26,
2016. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons
explained below, we do not find error in the Examiner's rejections.
Accordingly, we AFFIRM.
Appeal2018-000319
Application 13/779,683
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates to a cold-molding process for
loading a stent onto a stent delivery system." Spec. 1. 1 Method claims 36
and 40 are independent. Claim 3 6 is illustrative of the claims on appeal and
is reproduced below.
36. A method of crimping a stent onto a balloon of a delivery
catheter, the method comprising:
providing a crimping tool;
disposing a stent about a balloon of a delivery catheter, the
stent comprising a proximal end portion, a distal end portion, and
an intermediate portion, each portion having a plurality of
interstices defined therein;
placing the balloon and the stent within the crimping tool;
partially inflating the balloon to a pressure less than a
preferred rated burst pressure of the balloon after disposing the
stent about the balloon;
actuating the crimping tool to compress the stent on the
balloon while the balloon is partially inflated to the pressure less
than the preferred rated burst pressure of the balloon;
depressurizing the balloon while the crimping tool is still
actuated; and
de-actuating the crimping tool after the balloon is
depressurized,
wherein upon conclusion of the crimping process the
balloon extends non-uniformly into the plurality of interstices
along the stent.
REFERENCES RELIED ON BY THE EXAMINER
Morales
Brown et al.
us 6,141,855
US 6,352,547 Bl
(hereinafter "Brown '54 7")
Brown et al. US 6,769,161 B2
Nov. 7, 2000
Mar. 5, 2002
Aug. 3, 2004
1 Appellants' "SUBSTITUTE SPECIFICATION - CLEAN VERSION"
lacks both line and paragraph numbering. Hence, we reference Appellants'
Specification via page number only.
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Application 13/779,683
(hereinafter "Brown ' 161 ")
THE REJECTIONS ON APPEAL
Claims 36, 37, 39--41, and 43--462 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Brown '547 and Brown '161.
Claims 38 and 42 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Brown '54 7, Brown '161, and Morales.
ANALYSIS
The rejection of claims 36, 3 7, 39-41, and 43--46
as unpatentable over Brown '547 and Brown '161
Appellants argue independent claims 36 and 40 together. App. Br. 6-
12. We select claim 36 for review, with claims 37, 39--41, and 43--46
standing or falling with claim 36. See 37 C.F.R. § 4I.37(c)(l)(iv).
Regarding the rejection of claim 36, the Examiner primarily relies on
the teachings of Brown '547, but acknowledges that this reference "does not
disclose that upon conclusion of the crimping process the balloon extends
non-uniformly into the plurality of interstices along the stent" as recited in
the last "wherein" clause. Final Act. 3. The Examiner relies on Brown '161
for such teachings. Final Act. 3 (referencing Brown '161 7:13-30). The
Examiner submits "that based upon the similar nature of these processes, the
2 The Examiner does not initially list claim 43, but addresses claim 43 in the
body of the rejection. See Final Act. 2, 6. Appellants do not dispute that
claim 43 is also rejected under Brown '547 and Brown '161. See App. Br.
6-7.
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Application 13/779,683
Brown et al. ('547) method would likely produce the same result."3 Final
Act. 3; see also Ans. 3, 6, 10.
Appellants contend,
the Office Action improperly assumes that a crimping result
(i.e., "recoil crimping" which provides balloon material
between struts of a stent) described explicitly for only one
particular crimping embodiment (i.e., a polymeric braided
sleeve crimper) out of seven disclosed in Brown' 161 could be
achieved using any other crimping embodiment - including that
of the reducible diameter loop crimper of a wholly separate
disclosure (Brown '547).
App. Br. 7; see also Reply Br. 1. Accordingly, "the art of record cannot be
properly combined and modified as apparently proposed by the Office
Action." App. Br. 7.
First, it is abundantly clear that
The PTO bears the initial burden of showing a prima
facie case of obviousness. In re Sullivan, 498 F.3d 1345, 1351
(Fed. Cir. 2007). When a prima facie case of obviousness is
made, the burden then shifts to the applicant to come forward
with evidence and/or argument supporting patentability. In re
Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002).
In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014). See also In re
Kumar, 418 F.3d 1361, 1366 (Fed. Cir. 2005) ("During examination, the
examiner bears the initial burden of establishing a prima facie case of
obviousness."). Kumar also expresses the proposition that if the Examiner
produces sufficient evidence to support a prima facie case, the burden shifts
3 The Examiner also states, "[ o ]therwise, it at least would have been obvious
to one of ordinary skill in the art at the time of invention to have ensured this
result in order to have provided enhanced friction between the stent and
balloon." Final Act. 3.
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Application 13/779,683
to Appellants to produce evidence or argument in rebuttal. See Kumar, 418
F.3d. at 1366 (citing In re Piasecki, 745 F.2d 1468, 1475 (Fed. Cir. 1984)).
As regarding the establishment of a prima facie case of obviousness
( afterwhich the burden of persuasion shifts to Appellants to come forward
with evidence to the contrary), we have been instructed, "all that is required
of the office to meet its prima facie burden of production is to set forth the
statutory basis of the rejection and the reference or references relied upon in
a sufficiently articulate and informative manner as to meet the notice
requirement of [35 U.S.C.] § 132." In re Jung, 637 F.3d 1356, 1363 (Fed.
Cir. 2011).
Appellants do not dispute that the statutory basis of the rejection was
not appropriately set forth, or that the references relied upon were not
sufficiently articulated, or that Appellants were not properly notified of the
manner by which the Examiner deemed claim 3 6 to be obvious. Instead,
Appellants contend, "there is no suggestion that the crimping results of the
one crimper embodiment of Brown '54 7 could or would render the same
result as one of the seven wholly separate embodiments of Brown '161."
App. Br. 7; see also Reply Br. 1. In other words, Appellants are not
disputing that both Brown references disclose the act of crimping; instead,
Appellants contend that there is "no suggestion" that "the crimping results of
the one crimper embodiment ... could or would render the same result" as
disclosed in the other embodiment. App. Br. 7; see also Reply Br. 1.
The Examiner disagrees with Appellants' assertion stating that
similarity of results "would have been inherent to or at least obvious in view
of the nearly identically recited method of the primary reference Brown
'54 7" as that "recited in the secondary reference Brown '161." Ans. 3; see
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also Final Act. 3 ("based upon the similar nature of these processes"). To be
clear, the Examiner addresses the techniques employed in both of the Brown
references and states, "their results would have been similar, or at the very
least, the recoil crimping method as disclosed by Brown '161 would have
been compatible with Brown '547." Ans. 6; see also id. at 8, 9.
Appellants, on the other hand, assert that "none of the embodiments of
Brown' 161 are the same as disclosed in Brown '547." App. Br. 8.
However, the question is not whether the embodiments themselves are "the
same"; instead, the question is whether their respective processes are similar
enough to warrant the Examiner's conclusion that their respective results
would likewise be similar. In each of the Brown references, there is
disclosed a stent (having a plurality of interstices) positioned around and
crimped onto a partially inflated balloon. See references generally.
Appellants do not identify any stent structure in either reference that would
prevent the balloon from extending or expanding into such interstices when
the stent is crimped or pressed around the inflated balloon.
One argument presented by Appellants is that the two Brown
references "depict [] differences between these stents." App. Br. 9; see also
Reply Br. 5. However, it is not disputed that the stents depicted in both of
the Brown references are wire-type stents that have interstices. See, e.g.,
Brown '547 Fig. 9; Brown' 161 Figs. 2, 3. Nevertheless, Appellants do not
explain how any such "differences" between these stents would preclude
balloon expansion into the stent' s interstices. Furthermore, claim 3 6 is silent
as to any particular structure of the stent ( other than having "a plurality of
interstices defined therein"). See Ans. 8.
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Appellants also acknowledge that "only one of the seven crimper
embodiments ... of Brown '161 discloses that balloon folds can be located
between the struts of the stent." App. Br. 9; see also Reply Br. 2, 3.
However, Appellants do not explain how this "only one" disclosure is not
sufficient in and of itself, or where multiple disclosures of a teaching are
mandated before such teachings can be considered by one skilled in the art.
In other words, Appellants do not explain how this "only one" teaching of
crimping a stent about a balloon fails to teach balloon folds in the interstices
of the stent. See Brown '161 7: 18-22. The Examiner explains that the
additional reliance on Brown '161 is based, in part, on the fact that Brown
'161 not only describes a similar method, but also describes in greater detail
"the mechanism of securement, i.e. the balloon extending within the
interstices of the stent." Ans. 4. The Examiner also states, "the mere fact
that Brown ' 161 chooses to discuss the recoil crimping method in terms of a
single crimping means does not necessarily preclude its use with other
crimping means," and further, "the recoil crimping technique[] could have
applied beyond the narrow examples disclosed in Brown '161." Ans. 7.
Appellants further disagree with the Examiner's analysis "because the
processes described in Brown '54 7 and Brown ' 161 utilize different
crimping tools." App. Br. 10; see also Reply Br. 1, 2, 4. Similar to the
above, it is not relevant whether the tools themselves are different, the
question is whether the processes employed by each are similar enough such
that they would suggest to one skilled in the art that a similar outcome is to
be expected. Appellants' focus on structure, and not the process of crimping
about a partially inflated balloon, is not persuasive of Examiner error.
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Appellants also allege that one skilled in the art "would not and could
not expect the method or crimper of one application to provide the same
results as those of the other."4 App. Br. 11; see also Reply Br. 1, 2.
However, Appellants do not explain how or why one skilled in the art, who
is aware of different devices that can crimp different stents about a partially
inflated balloon, would, nevertheless, expect each device to produce a
wholly different result. 5 Appellants have not shown persuasively that, based
on the similar nature of the Brown references, the Examiner erred by
contending similar methods "would likely produce the same result." Final
Act. 3; see also Ans. 3, 4.
Appellants present additional allegations relating to a lack of
motivation, hindsight, and a lack of reasonable expectation of success, as
well as an attempt to limit Brown '161 's teachings to only "polymeric
braided sleeve crimping." See App. Br. 11-12; Reply Br. 3, 4. These
allegations are equally unpersuasive to show the Examiner's reliance on the
similarities between the identified processes, and their results, that the
Brown references disclose was misplaced.
Accordingly, and based on the record presented, we sustain the
Examiner's rejection of claims 36, 37, 39--41, and 43--46 as unpatentable
over Brown '54 7 and Brown '161.
4 "Thus, it is improper to assume the alternative crimping tools of Brown
'547 and Brown' 161 will achieve the same crimping result." Reply Br. 2.
5 For example, consider a nail; whether the nail is driven by a hammer, a
rock or something else, and regardless of the nail's structure, the process
employed and the end result achieved are similar, i.e., a nail is driven (a
stent is crimped around a balloon).
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Appeal2018-000319
Application 13/779,683
The rejection of claims 38 and 42
as unpatentable over Brown '547, Brown '161, and Morales
The Examiner relies upon the additional teachings of Morales for
disclosing the additional limitations of dependent claims 38 and 42. Final
Act. 6. Appellants do not dispute these additional teachings, or the
combination of such teachings with those of the Brown references. Instead,
the respective additional limitations are recited and Appellants contend, "the
art of record does not disclose or suggest" same. App. Br. 12-13.
Appellants' contention is not persuasive the Examiner erred in relying on the
additional teachings of Morales. We sustain the Examiner's rejection of
claims 38 and 42 as being obvious over Brown '547, Brown '161, and
Morales.
DECISION
The Examiner's rejections of claims 36-46 are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended as set forth in 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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