Ex Parte Ren et al

Patent Trial and Appeal Board

Jun 30, 2016

12205083 (P.T.A.B. Jun. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/205,083 09/05/2008
94678 7590 07/05/2016
Armstrong Teasdale LLP (32736)
7700 Forsyth Boulevard
Suite 1800
St. Louis, MO 63105
FIRST NAMED INVENTOR
Brooke Ren
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.
046.US 6170
EXAMINER
TANNER, JOCELIN C
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
07/05/2016 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):
USpatents@armstrongteasdale.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BROOKE REN, DANILE 0. ADAMS, and JOHN C. OSLUND
Appeal2014-003884
Application 12/205,083
Technology Center 3700
Before NEALE. ABRAMS, ANNETTE R. REIMERS, and
GORDON D. KINDER, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Brooke Ren et al. (Appellants) appeal under 35 U.S.C. § 134(a) from
the Examiner's decision to reject under 35 U.S.C. § 103(a): (1) claims 1, 2,
4-6, 8-10, 20, 43, and 46--48 as unpatentable over Seguin
(US 2005/0033416 Al; iss. Feb. 10, 2005) and Yodfat (US 2005/0010281
Al; iss. Jan. 13, 2005); claim 7 as unpatentable over Seguin, and Yodfat,
and Melsheimer (US 2005/0234542 Al, iss. Oct. 20, 2005); claim 11 as
unpatentable over Seguin, Yodfat, and Quiachon (US 6,682,557B1; iss. Jan.
27, 2004); claims 12-14 as unpatentable over Seguin, Yodfat, and
Greenhalgh (US 2005/0131516 Al; iss. June 16, 2005); and claim 44 as
unpatentable over Seguin, Yodfat, and Frid (US 2004/0215332 Al; iss. Oct.
Appeal2014-003884
Application 12/205,083
28, 2004). Claims 16-19, 21-26, and 30-38 have been withdrawn from
consideration, and claims 3, 15, 27-29, 39--42, and 45 have been canceled.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to a bifurcated medical device for
treating a target site. Spec. 1 (Title); Figs. 1, 3-4. Claims 1 are 48
independent.
Claim 1 is illustrative of the claimed subject matter and recites:
1. A stent graft for treating a target site proximate to a
bifurcated lumen, the stent graft comprising:
a first tubular structure having a proximal end, a distal end,
and a side wall extending therebetween, the first tubular structure
comprising at least one fabric layer comprising a plurality of
braided metal strands, the plurality of braided metal strands
having opposing ends corresponding to the proximal and distal
ends of the first tubular structure such that at least some of the
plurality of the braided metal strands extend continuously from
the proximal end to the distal end and define a hinge
therebetween, the first tubular structure comprising an opening
defined within the side wall and through the plurality of braided
metal strands,
wherein the first tubular structure comprises an expanded
preset configuration, and wherein the hinge extends across the
opening so as to define a first portion and a second portion having
respective lumens in the expanded preset configuration,
wherein the first portion has first and second ends and the
second portion has first and second ends, wherein the opening
corresponds to the first ends of the first and second portions and
the second ends of the first and second portions respectively
correspond to the proximal and distal ends of the first tubular
structure and at least a portion of the first and second portions are
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Application 12/205,083
configured to be positioned within respective branches of a
bifurcated lumen,
wherein the first tubular structure is configured to be
radially constrained by axial elongation to a smaller diameter
than the expanded preset configuration and return to the
expanded preset configuration when unconstrained, and
wherein the first and second portions are configured to be
coaxially aligned for delivery within a catheter.
ANALYSIS
Obviousness over Seguin and Yodfat
Claims 1, 2, 4-6, 8-10, 20, 43, and 46-48
Appellants present the same arguments for independent claim 48 as
those presented for independent claim 1. See Appeal Br. 3-9; see also Reply
Br. 1-3. Appellants do not present arguments for claims 2, 4-6, 8-10, 20,
43, 46, and 47 separate from those presented for claims 1 and 48. See id. at
9. We select claim 1 as representative. Claims 2, 4-6, 8-10, 20, 43, and 46-
48 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv) (2013).
Claim 1 is drawn to a stent with a fabric layer comprising "a plurality
of braided metal strands ... the braided metal strands extend continuously
from the proximal end to the distal end." Appeal Br. 11, Claims App. The
Examiner finds that Seguin discloses the device of claim 1 substantially as
claimed, including a support structure extending continuously from the
proximal end to the distal end (see Ans. 11) formed of metal "wire supports
[0051]." See Final Act. 2-3. The Examiner finds that Seguin does not
disclose the metal wire support structure being "braided" but that Seguin
does disclose that "wire supports may be a variety of self-expandable
configurations." Id. at 2-3; see also id. at 10.
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The Examiner relies on Y odfat for disclosure of the "braided"
limitation. See Final Act. 3--4, 9-10. The Examiner concludes that it would
have been obvious "to have formed the at least one fabric layer of Seguin of
braided filaments, as taught by Y odfat, to provide flexibility and elastic
compressibility to the stent." Id. at 4.
Appellants present a first set of arguments contending that the
Examiner improperly combines the teachings of Seguin and Y odfat. See
Appeal Br. 4-7.
First, Appellants contend that the Examiner fails to provide a reason
with rational underpinnings to combine Seguin and Y odfat. See Appeal Br.
5-6. Specifically, Appellants state that the Examiners proposed motivation
is at best a "broad conclusory statement" and that "the final Office Action
fails to explicitly provide an apparent reason for modifying Seguin using the
disclosure of Y odfat" Id. We disagree. Here, the Examiner articulates
adequate reasoning based on rational underpinnings to explain why one of
ordinary skill in the art would have been led to combine the teachings of
Seguin and Yodfat, namely, that "[i]t is well known to form stents of braided
material to gain the benefits of flexibility and easy manipulation" and
braiding facilitates "thrombus formation and epithelialization .... [and]
provides flexibility and elastic compressibility to the stent that [is] beneficial
when maneuvering through vasculature." See Final Act. 3--4.
Based on the Examiner's finding that Y odfat teaches braiding "to
provide flexibility and elastic compressibility to the stent" (see Final Act. 3-
4), Appellants contend that a skilled artisan would not be motivated to
modify the device of Seguin, which already discloses the properties of
flexibility and elastic compressibility. See Reply Br. 2. We are not
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Application 12/205,083
persuaded. As noted above, the Examiner points out Seguin permits using
other known self-expandable metal support structures. See Final Act. 3; see
also Seguin, para. 49. The Examiner states "[i]t is well known to form stents
of braided material to gain the benefits of flexibility and easy manipulation."
Id. The Examiner then provides Yodfat as an example that braiding was a
known self-expandable metal support structure. See id. Further, the
Examiner indicates additional properties/benefits of braiding, i.e., braiding
"provides various advantages used to treat the aneurysm such as facilitating
thrombus formation and epithelialization via the high permeability of the
mesh, skewing the blood flow away from the aneurysm to decrease rupture
possibility while still maintaining patency and providing flexibility during
delivery." Id. at 9-10. Thus, we are not persuaded that the Examiner failed
to provide adequate reasoning based on rational underpinnings to combine
Seguin and Y odfat.
Second, Appellants contend that the Examiner applied impermissible
hindsight in combining the references. See Appeal Br. 6. We are not
persuaded. As discussed above, the Examiner cites explicit teachings in the
references, not Appellants' disclosure, in articulating reasons for combining
the references as proposed in the rejection. See Final Act. 3--4; see also
Seguin, para. 49; Yodfat, para. 58.
Third, Appellants contend that Seguin does not suggest using braided
strands and "does not disclose any need or desirability for forming the
tubular support structure using braided strands." Appeal Br. 7. Appellants
contend that while Seguin discloses the support structures may be formed
from any variety of self-expandable tubular wire supports, Seguin does not
"provide guidance as to which other configurations may be used" and does
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Application 12/205,083
not "disclose specific configurations of these tubular wire supports, such as a
braided configuration." Reply Br. 1. Appellants' arguments are not
persuasive because nonobviousness cannot be established by attacking the
references individually when the rejection is predicated upon a combination
of prior art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). As discussed above, the Examiner relies on Y odfat for
disclosure of the "braided" limitation. See Final Act. 3-4, 9-10.
Fourth, Appellants contend that "the Examiner does not provide any
evidence that the braided strands would provide the requisite support,
porosity, or stability for the intended use." Appeal Br. 7. Appellants'
argument that the Examiner "does not provide any evidence" fails to apprise
us of how the combination of Seguin and Y odfat would not function as
intended. See id. Further, the Examiner expressly provides evidence that
the device would function as intended, pointing out that Seguin and Y odfat
are both directed to self-expandable stents intended for treating aneurysms
(see Final Act. 3) and that Seguin discloses using other self-expandable
configurations. See id.; see also Ans. 12. The Examiner further finds
Yodfat's braided self-expandable configuration provides "porosity and
flexibility that may be varied ... to obtain the desired stability and support."
Ans. 12. Based on the foregoing, we fail to see how modifying Seguin's
wire support structure to be braided, as taught by Y odfat, as the Examiner
proposes (see Final Act. 3--4, 10), would render Seguin unsatisfactory for its
intended purpose. As such, Appellants' argument is not persuasive of error
in the Examiner's findings.
Fifth, Appellants contend that there is "no suggestion to modify
Seguin' s sheath to comprise braided metal strands, given that Seguin
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discloses that the sheath is formed of synthetic polymeric materials."
Appeal Br. 7. As discussed above, the Examiner proposes modifying
Seguin' s metal tubular support structure (see Seguin, para. 51) with the
braided strands of Y odfat, not the polymeric sheath described in paragraph
46 of Seguin. See Final Act. 9-1 O; see also Reply Br. 1. In arguing a
different combination (see Appeal Br. 7) than that proposed by the Examiner
(see Final Act. 3--4, 10), Appellants have not apprised us of Examiner error.
Appellants further present a second set of arguments contending that
the Seguin and Y odfat combination "fails to teach or suggest each and every
element" of the subject invention. Appeal Br. 7. Claim 1 recites "an
opening defined within the side wall and through the plurality of braided
metal strands." Id. at 11, Claims App. Appellants argue that "neither
Yodfat nor Seguin describes how the recited openings of Appellant[s']
Claims 1 and 48 would be defined within the sidewall and through the metal
strands." Id. at 7 (emphasis added). Appellants further contend that Y odfat
provides no opening formed in the sidewall. Id.
Appellants' arguments are not persuasive. At the outset, to the extent
that Appellants are arguing the references must be capable of bodily
incorporation in order to combine their teachings, the test for obviousness is
not whether the features of a secondary reference may be bodily
incorporated into the structure of a primary reference. In re Keller, 642 F .2d
413, 425 (CCPA 1981). "Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill in the art." Id.
As noted above, the Examiner relies on Yodfat for the "braided" limitation,
not for the "opening." See Final Act. 3--4. The Examiner finds that Seguin
discloses an opening defined within the side wall of the sheath 60 and
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through the tubular wire support structure 62A, 62B. See Ans. 12. Thus,
Appellants argument is unpersuasive of Examiner error.
Appellants further contend that the opening in Seguin is only defined
within sheath 60 of Seguin, not through the tubular wire support structure
62A, 62B to form first and second portions across a hinge. See Appeal Br.
8.
Appellants' argument is not persuasive. In this case, the Examiner
finds that the wire supports 62A, 62B extend integrally across an opening so
as to define first and second portions. See Final Act. 3; see also Seguin,
para. 52. The Examiner points out that Seguin discloses an opening
"defined within the sheath and through the support structure" to form a
hinge. Ans. 12 (emphasis added). We agree with the Examiner's finding.
As seen in Figure 5 of Seguin, sidewall of sheath 60 clearly has an opening,
however, the wire support structure is not illustrated with an opening/hinge
but rather as two separate first and second portions. In Figures 3 and 4 of
Seguin, the wire support structure is shown linked across an opening,
thereby forming a hinge and corresponding first and second portions.
Further, paragraph 52 of Seguin discloses that wire supports "may extend
integrally across the flexible connection 54" (emphasis added). See Final
Act. 3.
Appellants contend that Figure 6A does not show the wire support
structure at all, and as such, does not show that an opening is formed therein.
See Reply Br. 3. This argument is not persuasive. Figure 6A of Seguin,
illustrates wire supports that appear to extend across the flexible connection,
thereby forming an opening through the wire support structure 44A, 44B and
a hinge between first and second portions. See Ans. 12. Additionally,
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Seguin clearly indicates the wire support structure in Figure 6A at 44A, B
and the sheaths at 74A, B. See Seguin, paras. 51-53, 55.
Appellants contend that Y odfat teaches away from providing braiding
in a bifurcated stent. See Appeal Br. 8. Appellants' argument is not
persuasive. "A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant." In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994). "A reference does not teach away, however,
if it merely expresses a general preference for an alternative invention but
does not 'criticize, discredit, or otherwise discourage' investigation into the
invention claimed." DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195,
1201 (Fed Cir. 2004)). In this case, Appellants have not shown where
Y odfat criticizes, discredits, or otherwise discourages using braiding in a
bifurcated stent. See Appeal Br. 8. On the contrary, other embodiments of
Y odfat specifically show that braiding can be used in a bifurcated stent
similar to that of Seguin. Cf Fig. 11 ofYodfat with Fig. 12 of Seguin.
Appellants contend that claim 1 also requires that the "metal braided
strands extend continuously from the proximal end to the distal end"
(Appeal Br. 11, Claims App.) and that Seguin lacks this claim feature (see
Reply Br. 2).
Appellants' argument is not persuasive because Appellants' argument
is an attack on the references individually rather than a challenge to the
Examiner's combination of the teachings of Seguin and Y odfat. See In re
Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986); In re Keller, 642 F.2d at 425.
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As discussed above, Seguin discloses an overall wire support structure
extending continuously from end to end (see Ans. 11 ), and Y odfat discloses
braid strands extending continuously (see Final Act. 10; see also Yodfat,
Fig. 11 ). We agree with the Examiner that the combined teachings of
Seguin and Y odfat "would result in the support structure of Seguin being
formed of a plurality of braided strands, as taught by Yodfat, which extend
continuously from the proximal end to the distal end and define a hinge and
opening." See Ans. 11.
Appellants contend that there is no "disclosure of an opening formed
within the support structure." Reply Br. 3. Appellants' contention is not
persuasive because it is not commensurate in scope with claim 1. The
opening being "formed within" the support structure is not recited in claim
1. See Appeal Br. 11, Claims App. Limitations not appearing in the claims
cannot be relied upon for patentability. In re Self, 671 F.2d 1344, 1348
(CCP A 1982). In addition, we must be careful not to read a particular
embodiment appearing in the written description into the claim if the claim
language is broader than the embodiment. See Superguide Corp. v. DirecTV
Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004).
Accordingly, for the foregoing reasons, we sustain the Examiner's
rejection of independent claim 1 as unpatentable over Seguin and Yodfat.
We further sustain the Examiner's rejection of claims 2, 4-6, 8-10, 20, 43,
and 46--48, which fall with claim 1.
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Obviousness over Seguin, Yodfat, and any ofMelsheimer, Quiachon,
Greenhalgh, or Frid
Claims 7, 11-14, and 44
Appellants do not present arguments for claims 7, 11-14, and 44
separate from those presented for claim 1. See Appeal Br. 9. Accordingly,
for the same reasons discussed above for claim 1, we sustain the Examiner's
rejections of (1) claim 7 as unpatentable over Seguin, Yodfat, and
Melsheimer; (2) claim 11 as unpatentable over Seguin, Y odfat, and
Quiachon; (3) claims 12-14 as unpatentable over Seguin, Yodfat, and
Greenhalgh; and ( 4) claim 44 as unpatentable over Seguin, Y odfat, and Frid.
DECISION
We AFFIRM the decision of the Examiner to reject claims 1, 2, 4-14,
20, 43, 44, and 46--48.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED
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