Ex Parte Clerc et al

Patent Trial and Appeal Board

Feb 24, 2016

12354392 (P.T.A.B. Feb. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/354,392 01115/2009
11050 7590 02/26/2016
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Claude Clerc
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.
2001.1435101 4720
EXAMINER
MATHEW, SEEMA
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
02/26/2016 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 CLERC and SRI TUPIL
Appeal2013-007143
Application 12/354,392
Technology Center 3700
Before MICHAEL L. WOODS, ERIC C. JESCHKE,
and MARK A. GEIER, Administrative Patent Judges.
WOODS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Claude Clerc and Sri Tupil ("Appellants") seek our review under
35 U.S.C. § 134(a) of the final rejection of claims 1-10, 13-17, and 24--30.
Appeal Br. 8-24; id. at 26-28 (Claims App). We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
Appeal2013-007143
Application 12/354,392
CLAIMED SUBJECT MATTER
Appellants' invention relates to an "intraluminal prosthesis having an
anti-migration feature." Spec. i-f 2. Claims 1, 14, and 24 are independent.
Claim 1 is reproduced below.
1. An intraluminal prosthesis having an outer surface, the
intraluminal prosthesis comprising:
a) a radially expandable tubular stent structure having a
length defining a longitudinal axis, said tubular structure
including an open wall structure and having an interior surface
and an exterior surface;
b) a polymeric covering having an interior surface and an
exterior surface, disposed on the exterior surface of said wall
structure; and
c) a three-dimensional anti-migration structure comprising
at least one strand of anti-migration filament;
wherein the three-dimensional anti-migration structure is
disposed on the polymeric covering so that a portion of the outer
surface of the prosthesis is formed by the polymeric covering and
a portion of the outer surface of the prosthesis is formed by the
three-dimensional anti-migration structure.
Appeal Br. 26 (Claims App.).
THE REJECTIONS
I. Claims 1, 2, and 4--10 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Shaolian (US 2002/0052644 Al, published May 2, 2002).
Final Act. 2.
II. Claims 24--30 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Schmitt (US 2004/0034403 Al, published Feb. 19, 2004).
Final Act. 4.
III. Claim 3 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Shaolian and Gianotti (US 2007/0123969 Al, published
May 31, 2007). Final Act. 6.
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Application 12/354,392
IV. Claim 13 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Shaolian and Greenberg (US 2007/0055365 Al, published
Mar. 8, 2007). Final Act. 7.
V. Claims 14--17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Shaolian and Schmitt '636 (US 5,503,636, issued Apr. 2,
1996). Final Act. 7.
ANALYSIS
Rejection I: Claims 1, 2, and 4-10 as Anticipated by Shaolian
Upon reviewing Rejection I, we note that the Examiner relied upon
different findings in the Final Office Action and in the Answer. In the Final
Office Action, the Examiner relied on Shaolian's element 46 as satisfying
the claimed "anti-migration" structure, but in the Answer, the Examiner
relied on elements 264, 266, and 268 as satisfying the claimed "anti-
migration" structure. Compare Final Act. 3, with Ans. 10; see also Reply
Br. 2 (contending that "the Examiner's Answer modified the rejection of
claims 1, 2, and 4--10 by Shaolian"). 1 Accordingly, our decision considers
the modified rejection as presented in the Answer.
1 By not petitioning to the Director within two months from the date of the
Answer, Appellants waived any arguments that the rejection in the Answer
should be designated as a new ground of rejection. See 37 C.F.R. § 41.40(a)
("Failure of appellant to timely file such a petition will constitute a waiver of
any arguments that a rejection must be designated as a new ground of
rejection").
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Application 12/354,392
Rejection I: Claims 1, 5, and 8-10
Appellants contest the rejection of claims 1, 5, and 8-10 collectively.
See Appeal Br. 8-11 (contesting claims 1, 2, and 4--10 collectively); see also
Reply Br. 2--4 (presenting arguments for dependent claims 2, 4, 6, and 7,
only). In accordance with 37 C.F.R. § 41.37(c)(l)(iv), we select claim 1 as
the representative claim to decide the appeal of the rejection of these claims,
with claims 5 and 8-10 standing or falling with claim 1.
In rejecting claim 1, the Examiner finds that Shaolian discloses the
claimed prosthesis 42 comprising, inter alia, a stent structure formed by
filaments 60, polymeric covering 44, and three-dimensional anti-migration
structure 264, 266, and 268. Ans. 10 (citing Shaolian: Figs. 5, 39A-39C; i-fi-1
189-192).
Figures 1 and 2 of Shaolian are provided below:
Figures 1 and 2 depict prosthesis 42 with tubular wire support 46 and
polymeric sleeve 44. Shaolian i-fi-1 7 4, 77.
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Figures 39A and 39B of Shaolian are reproduced below:
Figures 39A and 39B depict exoskeleton 264 and exoskeleton
segment 266, with Figure 39A specifically showing exoskeleton segment
266 extending beyond the end of the graft fabric (not numbered) and folded
back at proximal bend 60 on top of the fabric for "providing resistance to
migration of the implanted graft." Shaolian i-fi-f 189, 190.
In the Appeal Brief, Appellants argue that the rejection is in error,
because the Examiner's (initial) finding that Shaolian's tubular wire support
46, which is part of the stent structure, cannot satisfy the claimed "anti-
migration structure." See Appeal Br. 8-11; see also Final Act. 3 (finding
element 46 as satisfying the "anti-migration filament").
Although the rejection in the Answer differs from the rejection in the
Final Office Action, Appellants do not present revised arguments addressing
the new rejection (at least with respect to claims 1, 5, and 8-10), and rely on
those arguments presented in the Appeal Brief. See Reply Br. 2--4.
Although we agree with Appellants' argument that the initial rejection
is flawed-as Shaolian's tubular wire support 46 does not satisfy the
claimed "anti-migration structure" (Final Act. 3}-Appellants' argument is
not responsive to the revised rejection, which finds (in part) that Shaolian's
exoskeleton 264, 266 (rather than wire support 46) satisfies the claimed
"anti-migration structure." Ans. 10. Furthermore, upon reviewing Shaolian,
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Application 12/354,392
the Examiner's revised finding-that Shaolian's exoskeleton 264, 266
satisfies the claimed "anti-migration structure"-is supported by a
preponderance of the evidence. In particular, exoskeleton 264 comprises "at
least one strand of anti-migration filament" 266, and by being "folded over"
the graft fabric (or polymeric covering), exoskeleton 264 "is disposed on the
polymeric covering," as recited in claim 1.2 Appeal Br. 26 (Claims App.).
For the foregoing reasons, we sustain the rejection of claim 1, and of
claims 5 and 8-10, which fall with claim 1, under Rejection I.
Rejection I: Claim 2
Claim 2 depends from claim 1 and further recites, "wherein said anti-
migration structure is selected from a group consisting of polyethylene,
terepthalate, nylon, polyethylene, polytetrafluoroethylene, polypropylene,
polyurethane, polyamide, silicone, and combinations thereof." Appeal Br.
26 (Claims App.) (emphasis added).
In rejecting claim 2, the Examiner finds that the "anti-migration
structure is selected from a group consisting of polytetrafluoroethylene," or
PTFE. Final Act. 3 (citing Shaolian i-f 83).
Appellants disagree with the Examiner's finding. Reply Br. 2-3.
Upon reviewing the record, Appellants are correct, in that paragraph
83 of Shaolian does not disclose the claimed feature. Id. Although
2 We note that Shaolian supports a finding that the "graft fabric"
(unnumbered) of Figure 39A may be the "polymeric sleeve" 44 of Figures 1
and 2, as Shaolian discloses that "polymeric sleeve 44 may be formed from a
variety of synthetic polymeric materials ... including ... woven textiles."
Shaolian i-f 75. We further note that exoskeleton 264, 266 of Figures 39A-
39C "may be provided on any of the embodiments," including the
embodiment of Figures 1 and 2. Id. i-f 189.
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Application 12/354,392
paragraph 83 discloses that the wire may be coated with PTFE, that
paragraph does not disclose that the "structure" of the wire is made from any
of the materials listed in the claim. Compare Shaolian i-f 83, with claim 2.
Instead, paragraph 83 discloses that the structure of the wire may be made
from "different alloys, such as elgiloy, nitinol or MP35N, or other alloys
which include nickel, titanium, tantalum, or stainless steel, high Co-Cr
allows or other temperature sensitive materials." Shaolian i-f 83.
For the foregoing reason, we do not sustain the rejection of claim 2
under Rejection I.
Rejection I: Claim 4
Claim 4 depends from claim 1 and further recites, "wherein said anti-
migration structure is integrally formed with said polymeric covering and is
at least partially embedded in said polymeric covering." Appeal Br. 26
(Claims App.) (emphases added).
In rejecting claim 4, the Examiner finds that Shaolian's Figure 1 and
paragraphs 7 4 and 77 disclose the claimed feature. Final Act. 3.
Appellants disagree with the Examiner's finding, pointing out that
Shaolian's "exoskeleton [264, 266] appears to be an extension of the tubular
support." Reply Br. 3.
Upon reviewing the record, we cannot sustain the rejection, as the
Examiner makes no finding and provides no explanation as to how
exoskeleton 264, 266 is "integrally formed with" or "partially embedded in
said" polymeric covering. Final Act. 3; Ans. 10-11. Instead, the
Examiner's only finding with respect to this claim limitation relates to the
original rejection (presented in the Final Office Action), which is premised
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on wire support 46 as satisfying the claimed "anti-migration structure."
Final Act. 3.
Furthermore, Shaolian's exoskeleton 264, 266 is simply folded over
the "polymeric covering," and cannot reasonably be interpreted as being
"integrally formed with" or "partially embedded in" it. Shaolian i-fi-f 189,
190, and Fig. 39A.
For the foregoing reasons, we do not sustain the rejection of claim 4
under Rejection I.
Rejection I: Claim 6
Claim 6 depends from claim 1 and further recites, "wherein said anti-
migration structure comprises a plurality of anti-migration filaments
disposed on said polymeric covering at a plurality of regions." Appeal Br.
26 (Claims App.) (emphasis added).
In rejecting claim 6, the Examiner finds that the "anti-migration
filaments #46 disposed on said polymeric covering #44 at a plurality of
regions." Final Act. 3 (citing Shaolian i178).
Appellants disagree with the Examiner's finding, giving the Examiner
the benefit of the doubt that the Examiner instead intended to rely on
Shaolian's exoskeleton 264, 266 as the claimed "anti-migration structure."
See Reply Br. 3--4 (citing Spec. Figs. 11, 13).
Upon reviewing the record, we cannot sustain the rejection, as the
Examiner makes no finding and provides no explanation as to how
exoskeleton 264, 266 is disposed on "a plurality of regions" of the polymeric
covering. Final Act. 3; Ans. 10-11. Instead, the Examiner's only finding
with respect to this claim limitation relates to the original rejection
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Application 12/354,392
(presented in the Final Office Action), which is premised on wire support 46
as satisfying the claimed "anti-migration structure." Final Act. 3.
Furthermore, Appellants' assertion that Shaolian' s exoskeleton 2 64,
266 is not disposed "at a plurality of regions," as required by claim 6,
appears correct. Reply Br. 3--4. Instead, exoskeleton 264 appears to be
disposed only at one region, which is near the "top of the fabric as illustrated
in FIG. 39a." Shaolian i-f 190 and Fig. 39A.
For the foregoing reasons, we do not sustain the rejection of claim 6
under Rejection I.
Rejection I: Claim 7
Claim 7 depends from claim 1 and further recites, "wherein said anti-
migration structure comprises a pattern selected from the group consisting of
a helical pattern, an open weave pattern, an open knit pattern, a molded
pattern, and combinations thereof" Appeal Br. 27 (Claims App.) (emphasis
added).
In rejecting claim 7, the Examiner finds that Shaolian's Figures 1, 2,
16, 17, and paragraphs 75 and 78 disclose this feature. Final Act. 4.
Appellants disagree with the Examiner's finding. Reply Br. 4.
Upon reviewing the record, the Examiner's only finding is premised
on the original rejection (presented in the Final Office Action), which is
based on Shaolian's wire support 46 as meeting the claimed "anti-migration
structure." Final Act. 4; Ans. 10-11. In other words, the Examiner makes
no finding as to how Shaolian's exoskeleton 264, 266 meets the claimed
limitation.
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Application 12/354,392
Furthermore, Appellants' assertion that Shaolian' s exoskeleton 2 64,
266 is not a "helical pattern," an "open weave pattern," an "open knit
pattern," or a "molded pattern," appears correct. See Reply Br. 4.
For the foregoing reasons, we do not sustain the rejection of claim 7
under Rejection I.
Rejection II: Claims 24-30 as Anticipated by Schmitt
In rejecting independent claim 24, and its dependent claims 25-30, the
Examiner finds that the embodiments of Schmitt's Figures 1--4 each disclose
the claimed prosthesis (10, 20, and 30) comprising, inter alia, an elastomeric
layer (11, 21, and 31) "forming the inner surface of the prosthesis," at least
one filament (12, 13, 22, 23, and 32), "wherein the outer surface of the
prosthesis is an irregular surface formed by the at least one filament and the
elastomeric layer." Final Act. 4--5 (citing Schmitt, Figs. 1--4, Abstract, and
iTiT 26-30).
Figure 1 of Schmitt is reproduced below:
./
Fig.1
Figure 1 depicts stent 10 composed of first elastic tubular layer 11 and
first helical filaments 12, 13. Schmitt iT 26.
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Application 12/354,392
Figure 2 of Schmitt is reproduced below:
' ... -----··j 24
21
27 t
Fig. 2
Figure 2 depicts stent 20, including first elastic tubular layer 21 and
first helical filaments 22, 23. Id. i-f 27.
Figure 3 of Schmitt is reproduced below:
_,... .. ·
37 ./'.. ... ,.. ... :·
..., ___ ~---., _,/' \
~"-'n········,..· )
......... ·
..
30
I i
34 \
32
\\
...... , ...... \ 37
, '
( ''(
:).5 -., ......
Fig. 3
Figure 3 depicts stent 30, including first helical filament 32 and first
elastic tubular layer 31. Id. i-f 28.
Figure 4 of Schmitt is reproduced below:
3G
Fig.4
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Figure 4 depicts "cross-section through a stent" including first elastic
tubular layer 31 and second elastic tubular layer 33. Id. i-f 29. First helical
filaments 3 2 are disposed on the outer surface of first elastic tubular layer 31
and are also surrounded by second elastic tubular layer 33. Id. Third elastic
tubular layer 35 is also depicted surrounding second helical filaments 34.
In contesting the rejection, Appellants propose two arguments; the
first argument is directed towards the embodiments depicted in Figures 1-3,
and the second argument is directed towards the embodiment depicted in
Figure 4. See Appeal Br. 13-16. We address each argument separately,
below.
First, and with respect to the embodiments depicted in Schmitt's
Figures 1-3, Appellants assert that "[a]s can be seen in Figs. 1-3, the outer
surface is smooth," and, accordingly, these embodiments do not anticipate
claim 24, which recites, "wherein the outer surface of the prosthesis is an
irregular surface." Appeal Br. 13 (emphasis omitted).
In response to Appellants' first argument, the Examiner explains that
Appellants' own Specification "define[s] that an irregularity includes 'a
wavy pattern' ... [and, because] Schmitt teaches the stent is formed of
filaments that form a helical (i.e., wave pattern) pattern," the limitation is
met by Schmitt. See Ans. 10 (citing Spec., Fig. 9 and i-f 42).
Upon reviewing the record, we disagree with the Examiner's finding
that Schmitt teaches this limitation. Even assuming arguendo, that "Schmitt
teaches the stent is formed of helical filaments," the Examiner has failed to
address the limitation, which requires that "the outer surface of the
prosthesis is an irregular surface." Appeal Br. 28 (emphasis added) (Claims
App.). As pointed out correctly by Appellants, Schmitt's Figures 1-3 depict
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a prosthesis with a smooth outer surface, and we do not see how a smooth
outer surface satisfies the claimed "irregular surface," as required by claim
24.
Second, and with respect to the embodiment of Schmitt's Figure 4,
Appellants assert that Schmitt's Figure 4 depicts "different tubular layers
[that] form the inner and outer surfaces of the prosthesis," and, therefore, the
elastomeric layer does not form both the inner surface and the outer surface
of the prosthesis, as required in claim 24. Appeal Br. 16; see id. at 14--15.
In response to Appellants' second argument, the Examiner explains
that "the prosthesis [has] a wall defining an inner surface (portion by 31) and
an outer surface (portion by 32), wherein the outer surface is formed by at
least one filament 32 and the elastomeric layer 33." Ans. 10-11.
Upon reviewing the record, the Examiner's finding that the two layers
31, 3 2 of Schmitt's Figure 4 satisfy the claimed limitation is not supportable.
In particular, claim 24 recites, "the elastomeric layer forming the inner
surface of the prosthesis ... wherein the outer surface of the prosthesis is ...
formed by the at least one filament and the elastomeric layer." Appeal Br.
28 (Claims App.); see also Spec. Figs. 4--5 (depicting elastomeric membrane
22 as forming both the inner surface 26 of prosthesis 10 and, along with anti-
migration elements 42, 44, the outer (exterior) surface 24 of prosthesis 10).
Importantly, claim 24 requires the same elastomeric layer to form both the
inner surface of the prosthesis and, at least in part, the outer surface of the
prosthesis. As pointed out correctly by Appellants, Schmitt's Figure 4
depicts a first elastomeric layer 31 as forming the inner surface of the
prosthesis and a different elastomeric layer 35 as forming the outer surface
of the prosthesis. Appeal Br. 15.
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For the foregoing reasons, we do not sustain the rejection of
independent claim 24, and its dependent claims 25-30, under Rejection II.
Rejection III: Claim 3 as Obvious over Shaolian and Gianotti
Claim 3 depends from claim 1 and further recites, "wherein said wall
comprises braided stent wires." Appeal Br. 26 (Claims App.) (emphasis
added).
In rejecting claim 3, the Examiner acknowledges that Shaolian does
not disclose braided stent wires, but determines that it would have been
obvious to modify Shaolian "to further include a plurality of wires that are
braided as taught by Gianotti for the purpose of creating a braided support
structure that is capable of self-expansion." Final Act. 6 (emphasis added).
In contesting the rejection, Appellants point out that the Examiner's
modified rejection relies on Shaolian's exoskeleton 264, 266 as being
"folded back over the graft fabric" and that "Gianotti does not suggest that
the braided tubular wall can be folded over on itself so as to form an
exoskeleton as disclosed in Shaolian." Reply Br. 9.
Upon reviewing the record, the Examiner does not supplement
Rejection III in the Answer to account for the fact that Rejection I was
modified, and that the new rejection is premised on a finding that
exoskeleton 264, 266 satisfies the claimed "anti-migration structure." See
Ans. 10-11. Importantly, Shaolian's exoskeleton 264, 266 (relied upon in
the modified rejection) is folded over at proximal bend 60, which is a hinged
connection. See, e.g., Shaolian i-f 190 and Figs. 5 and 39A. In the present
case, it appears that the Examiner proposes to replace these hinged proximal
bends 60 with a braided structure. In reviewing the record, however, it is not
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clear to us if replacement of these hinged bends 60 would continue to permit
exoskeleton 264, 266 to "fold over" the graft fabric while at the same time
permitting prosthesis 42 to self-expand, which is the reason for the proposed
modification. See Final Act. 6.
For the foregoing reason, we do not sustain the rejection of claim 3
under Rejection III.
Rejection IV: Claim 13 as Obvious Over Shaolian and Greenberg
In contesting the rejection of claim 13, which depends from claim 1,
Appellants rely on the same arguments presented with respect to claim 1.
Appeal Br. 21; see Reply Br. 2-11.
Accordingly, and for the same reasons we sustain the rejection of
claim 1 under Rejection I, we also sustain the rejection of claim 13 under
Rejection IV.
Rejection V: Claims 14-17 as Obvious Over Shaolian and Schmitt '636
As with Rejection I, the Examiner modifies Rejection IV in the
Answer. Specifically, the Examiner's original rejection (in the Final Office
Action) relied on Shaolian's wire support 46 as satisfying the claimed "anti-
migration filament," and the modified rejection relies on Shaolian' s
exoskeleton 264, 266 as satisfying this element. Compare Final Act. 8, with
Ans. 11.
In contesting the rejection of claim 14, Appellants point out that
Shaolian's exoskeleton 264, 266 is folded over graft fabric, and therefore,
does not satisfy the claimed limitation of "an anti-migration filament being
disposed on only a portion of said exterior surface of said open sleeve
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structure," which comprises metal. Reply Br. 10; Appeal Br. 27 (Claims
App.).
In rejecting claim 14, and its dependent claims 15-17, the Examiner
relies on segments 54 of wire support 46 as satisfying the claimed "open
sleeve structure" and exoskeleton 264, 266 as satisfying the claimed "anti-
migration filament." See Final Act. 8 (finding that segment 54 satisfy the
claimed "open sleeve structure"); see also Ans. 11 (finding that filaments
264, 266, 268 satisfy the claimed "anti-migration structure"); see also
Shaolian i-f 80 (describing wire support 46 as formed of discrete tubular
segments 54). Based on these findings, we do not see how or where
Shaolian discloses exoskeleton 264 "disposed on only a portion of [the]
exterior surface of' wire support 46 (or segment 54), as required by claim
14. Appeal Br. 27 (Claims App.). Instead, and as pointed out correctly by
Appellants, exoskeleton 264, 266 is instead disposed on Shaolian's graft
fabric. Shaolian Fig. 39A and i-fi-1189, 190.
For the foregoing reasons, we do not sustain the rejection of
independent claim 14, and its dependent claims 15-17, under Rejection V.
SUMMARY
The Examiner's decision to reject claims 1, 5, and 8-10 under
35 U.S.C. § 102(b) as anticipated by Shaolian is affirmed.
The Examiner's decision to reject claims 2, 4, 6, and 7 under
35 U.S.C. § 102(b) as anticipated by Shaolian is reversed.
The Examiner's decision to reject claims 24--30 under 35 U.S.C.
§ 102(b) as anticipated by Schmitt is reversed.
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The Examiner's decision to reject claim 3 under 35 U.S.C. § 103(a) as
unpatentable over Shaolian and Gianotti is reversed.
The Examiner's decision to reject claim 13 under 35 U.S.C. § 103(a)
as unpatentable over Shaolian and Greenberg is affirmed.
The Examiner's decision to reject claims 14--17 under 35 U.S.C.
§ 103(a) as unpatentable over Shaolian and Schmitt '636 is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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