Ex Parte Kassab et al

Patent Trial and Appeal Board

Jul 25, 2016

12562713 (P.T.A.B. Jul. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/562,713 09/18/2009
22045 7590 07/27/2016
BROOKS KUSHMAN P,C
1000 TOWN CENTER
TWENTY-SECOND FLOOR
SOUTHFIELD, MI 48075
FIRST NAMED INVENTOR
Elias Habib Kassab
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.
KKED0112PUS 4798
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
07/27/2016 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):
docketing@brookskushman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELIAS HABIB KASSAB and MARK EDWIN ZYZELEWSKI
Appeal2014-004268
Application 12/562,713
Technology Center 3700
Before JILL D. HILL, THOMAS F. SMEGAL, and
ERIC C. JESCHKE, Administrative Patent Judges.
SMEGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Elias Habib Kassab and Mark Edwin Zyzelewski (Appellants )1 seek
our review under 35 U.S.C. § 134 of the Examiner's decision2 under 35
U.S.C. § 103(a), rejecting claims 1, 2, 15-17, and 22 as unpatentable over
Chambers (US 2004/0181272 Al, pub. Sept. 16, 2004), Hopkins (US
2007/0239252 Al, pub. Oct. 11, 2007), and Fischell (US 2007/0225788 Al,
pub. Sept. 27, 2007); and claim 7 as unpatentable over Chambers, Hopkins,
1 According to Appellants, the real party in interest is Kassab Kughn
Endovascular Devices LLC. Appeal Br. 1.
2 Appeal is taken from the adverse decision of the Examiner as set forth in
the Final Action, dated February 12, 2013 ("Final Act.").
Appeal2014-004268
Application 12/562,713
Fischell, and Ray (US 2001/00041858 Al, pub. Nov. 15, 2001). We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
CLAIMED SUBJECT MATTER
Claim 1, the sole independent claim, is reproduced below and
illustrates the claimed subject matter, with disputed limitations emphasized.
1. A catheter system for placing a medical device proximate an
ostium of an artery to treat an ostial lesion, the catheter system
compnsmg:
a guide catheter having a tubular wall, and an internal lumen
with a proximal end and a distal end;
a sheath that has a proximal end, a distal end, and an internal
lumen along virtually the entire length of which the guide catheter
slidably extends;
an actuating mechanism associated with the proximal end of the
sheath, the guide catheter or the sheath and guide catheter;
connecting components disposed within the tubular wall of the
guide catheter, the guide catheter and the connecting components
extending slidably axially within the sheath, each connecting
component having a proximal end that extends from the actuating
mechanism; and
an ostial locating member that is attached to and extends from
the distal ends of the connecting components so that the ostial locating
member lies within the sheath before deployment and when the ostial
locating member is retracted;
the ostial locating member having two or more flexible, radially
and axially extending struts that terminate distally in radio-opaque feet
which are positioned transversely in relation to a longitudinal axis of
the guide catheter, sit astride an ostium defined by a branch vessel and
lie in an ostial plane when they are advanced against the ostium by
distally directed axial sliding movement of the connecting components,
the axial sliding movement of the connecting components being
initiated by the actuating mechanism;
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the radio-opaque feet and the struts protruding beyond the distal
end of the sheath when the radio-opaque feet of the ostial locating
member are positioned astride the ostium, the struts when extended
having an outside diameter that lies between 4 and 15 mm.
ANALYSIS
Obviousness of Claims 1, 2, 15-17, and 22 over Chambers, Hopkins,
and Fischel!
Appellants argue claims 1, 2, 15-1 7, and 22 together in contesting the
rejection of these claims as obvious over Chambers, Hopkins, and Fischell.
See Appeal Br. 4-7; Reply Br. 2-3. We select claim 1 as the representative
claim for this group, and the remaining claims stand or fall with claim 1.
See 37 C.F.R. 41.37(c)(l)(iv). We have considered Appellants' arguments
raised in the Appeal and Reply Briefs, but do not find them persuasive to
demonstrate error in the Examiner's rejection of claim 1 as being obvious
over Chambers, Hopkins, and Fischell.
In rejecting claim 1, the Examiner finds that Chambers "discloses a
catheter system for placing a stent (216) at an ostium," including, inter alia,
"[a Jn ostial locating member (212) compris[ing] a plurality of flexible,
radially and axially extending struts (230) [where the] ostial locating
member (212) is attached to the distal end of [a] guide catheter (218), so that
movement of the guide catheter relative to [a] sheath (210) deploys the
struts." Final Act. 2 (citing Chambers, Figs. l 5A-B, 16; para. 59).
The Examiner looks to Hopkins for disclosing "another catheter
assembly for delivering a stent to an ostium" and teaching
an alternate configuration for controlling movement of an ostial
locating member, wherein the struts (distal ends of elements 130)
are attached to the distal ends of connecting components
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(proximal ends of elements 130) that extend from an actuating
mechanism (112) at the proximal end (104) of the device, [where
the] connecting components (130) are located within channels
(138) in the wall of the guide catheter (122) [so that] the operator
selectively deploys the ostial locator member by distal
movement of the actuator (112).
Final Act. 3 (citing Hopkins, Figs. 1-5).
Id.
Based on the foregoing, the Examiner reasons that
[ o ]ne of ordinary skill in the art ... would have found it obvious
to configure the struts of the Chambers device to be attached to
distal ends of connecting components extending from an
actuating mechanism at the proximal end of the device, as taught
by Hopkins, [as] this modification provides an alternative
mechanism for actuating an ostial locator member at the distal
end of a guide catheter with predictable results.
Appellants take issue with the analysis and conclusions presented in
the Final Action, first contending that "[t]o avoid hindsight bias, some
evidence must be provided by the Examiner that shows a reason to combine
the prior art to arrive at the claimed invention," contending that "[t]he record
is devoid of any reason for someone to combine these references." Appeal
Br. 4.
However, as the Examiner explains, while "any judgment on
obviousness is in a sense necessarily a reconstruction based upon
hindsightreasoning," "so long as it takes into account only knowledge which
was within the level of ordinary skill at the time the claimed invention was
made, and does not include knowledge gleaned only from the applicant's
disclosure, such a reconstruction is proper." Ans. 5. Furthermore, the
Examiner did provide a rationale explaining why one of skill in the art
would have combined Hopkins with Chambers; namely, that the
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combination "provides the operator with greater control over retraction/
deployment of the struts." Final Act. 3. Appellants have not apprised us
that the Examiner's rationale is in error.
Appellants also contend that "[t]he claimed system includes
connecting components that lie within tunnels (72) defined within the
tubular wall of the guide catheter (14)," so that "connecting
component (34) may therefore twist in relation to the tunnel in which it lies,"
whereas "the tunnels of Hopkins are rectangular." Appeal Br. 4. 3
Appellants reason that "[ s ]uch tunnels [of Hopkins] would be inoperative
because connecting components contained there within would be unable to
twist during insertion into and removal from a tortious vasculature." Reply
Br. 2-3. Appellants also contend that "the claimed invention imbues the
necessary flexibility of the catheter system during the endovascular
procedure." Id. at 3.
However, Appellants' contention amounts to unsupported attorney
argument, and thus is entitled to little, if any, weight. See In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984) (holding that arguments and conclusions
unsupported by factual evidence carry no evidentiary weight). Moreover,
the Examiner explains "the Final rejection mailed 2/12/2013 is based on
3 In mapping claim 1, Appellants contend that "[t]he catheter system further
includes connecting components (34) disposed within the tubular wall of the
guide catheter." Appeal Br. 3 (citing Specification Figs. 11-12). However,
the only disclosure present in Figures 11-12 is of connecting component
(34) being located in tunnel (72) in the wall of sheath 22, not in the wall of
catheter 14. See also Specification 14, 11. 7-8. Thus, if there is further
prosecution of this application, the Examiner may wish to consider whether
claim 1 should be rejected under 35 U.S.C. § 112, first paragraph, as failing
to comply with the written description requirement.
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claims filed 12117112," which "do not recite any limitations regarding a
particular cross-sectional shape of the tunnels and/or connecting
components," and the Examiner concludes that "[a ]lthough the claims are
interpreted in light of the specification, limitations from the specification are
not read into the claims." Ans. 6. We agree.
Appellants also contend that "[i]n Chambers there is no relative
movement between the ostial locating members (212) and the guide catheter
(218)," whereas "the claimed invention calls for the ostial locating members
to be attached to the connecting components that slide within the catheter's
wall." Appeal Br. 5. However, Appellants are simply attacking Chambers
in isolation for lacking support of findings not relied upon by the Examiner,
rather than addressing the Examiner's proposed combination of Chambers,
Hopkins, and Fischell. Nonobviousness cannot be established by attacking
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 the Examiner reasons, "Hopkins is properly relied upon for
teaching that deployment of ostial locating struts may alternatively be
controlled by connecting members (130) extending through tunnels (138) in
the guide catheter (122)," and that
one of ordinary skill in the art would have found it obvious to
combine the actuation mechanism [of Hopkins], connecting
components (130), with the Chambers device, as the
modification merely involves a combination of known device[ s]
according to known methods to obtain a predictable result of
deploying ostial locating members to an expanded shape.
Ans. 7-8.
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We agree that such a predictable use of prior art elements according to
their established functions, when such use is within the skill of one of
ordinary skill in the art, would have been obvious. See KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 417 (2007) ("using [a prior art] technique [to
improve similar devices in the same way] is obvious unless its actual
application is beyond [the skill of a person of ordinary skill").
Appellants then contend that "[i]t is inappropriate to combine
[Hopkins and Fischell with Chambers] in the manner proposed in the
absence of any teaching, suggestion or motivation to do so," reasoning that
"[a] person of skill in the art would not be motivated to develop a catheter
system as claimed by making the proposed combination with any reasonable
expectation of success." Appeal Br. 5. However, to the extent that
Appellants are arguing that there is no explicit teaching, suggestion, or
motivation to combine the references, this argument is foreclosed by KSR,
550 U.S. at 415, in which the Court rejected the rigid requirement of a
teaching, suggestion, or motivation to combine known elements in order to
show obviousness.
Furthermore, as the Examiner points out, because
[t]he ostial locating struts [230 of Chambers] are deployed by
movement of the guide catheter [216] relative to the sheath
(21 O)[,] Hopkins is properly relied upon for teaching that
deployment of ostial locating struts may alternatively be
controlled by connecting members (130) extending through
tunnels (138) in the guide catheter (122).
Ans. 7 (citing Hopkins, Fig. 4).
Appellants continue by contending that "the combination of
references would render the final product to be inoperable for its intended
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use in light of the missing teachings discussed earlier." Appeal Br. 5-6.
However, as noted above, we disagree that there are any missing teachings.
Appellants also contend that "the art 'teaches away' from the claimed
invention" because "the ends of Hopkins' struts are oriented radially
inwardly upon deployment and are constrained by the basket assembly of
anchor (128)." Appeal Br. 6-7 (citing Hopkins, Figs. 2, 5). However, a
reference does not teach away if it does not "criticize, discredit, or otherwise
discourage" investigation into the claimed subject matter. In re Fulton, 391
F.3d 1195, 1201 (Fed. Cir. 2004). A differing radial orientation does not
amount to disclosure that criticizes, discredits, or discourages investigation
into the claimed subject matter. We agree with the Examiner that "[t]he
teachings of Hopkins are considered to be directly applicable to Chambers,
since both references are directed to the deployment of struts at a distal end
of a catheter for the purpose of aligning the instrument with a patient's
ostium." Ans. 6. Thus we find that the language of claim 1 does not
structurally distinguish from Chambers, Hopkins, and Fischell.
Appellants' final contention is that "[t]he Examiner has improperly
limited the focus to individual structural similarities between the claimed
invention and the prior art, and failed to consider the invention as a whole."
Appeal Br. 7. However, we agree with the Examiner that "[t]he teachings of
Hopkins are considered to be directly applicable to Chambers, since both
references are directed to the deployment of struts at a distal end of a
catheter for the purpose of aligning the instrument with a patient's ostium."
Ans. 6. The Examiner has provided "reasoning with some rational
underpinning to support the legal conclusion of obviousness" based on the
combined teachings of Chambers, Hopkins, and Fischell. In re Kahn, 441
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Application 12/562,713
F.3d 977, 988 (Fed. Cir. 2006) (quoted with approval in KSR, 550 U.S. at
418). We therefore are not apprised of error in the Examiner's findings and
conclusions.
In the Reply Brief, for the first time, Appellants argue that "[i]n claim
22, Applicant has claimed a 'catheter system ... wherein the connecting
components slide within tunnels that lie within the tubular wall of the guide
catheter," and that "[t]he specification clearly shows ... that 'tunnels' means
rounded or circular tunnels," which "are unlike those of Hopkins which do
not permit twisting of the connecting components in relation to the tunnels."
Reply Br. 3. However, Appellants did not present this argument in the
Appeal Brief, and it is not responsive to an argument newly raised in the
Examiner's Answer. Thus Appellants did not set forth this argument in a
timely manner prior to filing of the Reply Brief to permit the Examiner an
opportunity to fully respond. See 37 C.F.R. § 41.4l(b)(2) (2014) ("Any
argument raised in the reply brief which was not raised in the appeal brief, or
is not responsive to an argument raised in the examiner's answer ... will not
be considered by the Board for purposes of the present appeal, unless good
cause is shown.").
For these reasons, we sustain the rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over Chambers, Hopkins, and Fischell. Claims 2,
15-17, and 22 fall with claim 1.
Obviousness of claim 7 over Chambers, Hopkins, Fischel!, and Ray
Other than observing that "no combination with Ray et al. would
teach or suggest the missing elements discussed above [with respect to claim
1]," we understand Appellants' appeal of the rejection of claim 7 to rest on
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the arguments presented against the proposed combination of Chambers,
Hopkins, and Fischell, which we found not demonstrative of error in the
Examiner's rejection of claim 1, as set forth supra. See Appeal Br. 7. As
such, for the same reasons, we sustain the rejection of claim 7 under 35
U.S.C. § 103(a) as unpatentable over Chambers, Hopkins, Fischell, and Ray.
DECISION
We AFFIRM the Examiner's rejections.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § l.136(a)(l)(iv).
AFFIRMED
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