Ex Parte Stanford et al

Board of Patent Appeals and Interferences

Feb 2, 2012

10975851 (B.P.A.I. Feb. 2, 2012)

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.
10/975,851 10/28/2004 Ulf Harry Stanford 1001.1615102 5770
11050 7590 02/02/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
TYSON, MELANIE RUANO
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
02/02/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ULF HARRY STANFORD, YEM CHIN,
SHENG-PING ZHONG and JOHN A. GRIEGO
____________

Appeal 2009-010642
Application 10/975,851
Technology Center 3700
____________

Before JOHN C. KERINS, MICHAEL L. HOELTER and JAMES P.
CALVE, Administrative Patent Judges.

KERINS, Administrative Patent Judge.
DECISION ON APPEAL

Appeal 2009-010642
Application 10/975,851

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STATEMENT OF THE CASE
Ulf Harry Stanford et al. (Appellants) seek our review under 35
U.S.C. § 134 of the Examiner’s final rejection of claims 35, 36, 38, 40-42,
44, 45, 47, 48, 51-53 and 55-59. Claims 1-34, and 39 are canceled, and
claims 37, 43, 46, 49, 50 and 54 are withdrawn from consideration. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

THE INVENTION
Appellants’ invention is directed to a low profile emboli capture
device. Claims 35 and 51, reproduced below, are illustrative:
35. A low profile emboli capture device
comprising:

a guidewire having a proximal end and a distal
end;

a filter disposed about a distal portion of the
guidewire, the filter having a retracted position and
an expanded position, the filter being adapted to
capture emboli in its expanded position;

a stent attached to the filter; and

a sleeve extending over at least a portion of the
filter in the retracted position, the sleeve infolded
such as to form an inner layer and an outer layer,
wherein the inner layer of the sleeve is secured to
the guidewire.

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51. A low profile emboli capture device
comprising:

a guidewire having a proximal end, a distal end
and a cross-sectional profile, the guidewire
including a mounting region having a cross-
sectional profile less than the guidewire cross-
sectional profile;

a filter disposed about at least a portion of the
mounting region, the filter having a retracted
position and an expanded position, wherein in the
retracted position the filter has a cross-sectional
profile approximately the same as the cross-
sectional profile of the guidewire;

a stent attached to the filter; and

a sleeve disposed about at least a portion of the
guidewire and slidable thereon, the sleeve
including an inverted, double folded end portion
extending over the filter, wherein the sleeve is
movable between a first position for retaining the
filter in the retracted position and a second position
for releasing the filter in the expanded position,
further wherein the inner layer of the sleeve is
secured to the guidewire at a location proximal the
mounting region.

THE REJECTIONS
The Examiner has rejected
(i) claims 35, 36, 38, 40, 41, 44, 45, 47, 51-53 and 55-59 under 35
U.S.C. § 103(a) as being unpatentable over Green (US 6,485,501 B1, issued
Nov. 26, 2002) in view of Yurek (US 5,690,644, issued Nov. 25, 1997);
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(ii) claim 42 under 35 U.S.C. § 103(a) as being unpatentable over
Green, Yurek and Simon (US 4,425,908, issued Jan. 17, 1984); and
(iii) claim 48 under 35 U.S.C. § 103(a) as being unpatentable over
Green, Yurek and Ambrisco (US 6,007,557, issued Dec. 28, 1999).

ISSUES
Did the Examiner provide an articulated reason to combine the
teachings of Green and Yurek that is supported by rational underpinnings?
Did the Examiner err in finding that Green discloses a stent attached
to a filter?
Did the Examiner err in finding that Green discloses a guidewire that
includes a distal mounting region having a cross-sectional profile less than
the guidewire cross-sectional profile, with a filter disposed about at least a
portion of the mounting region?
ANALYSIS
Claims 35, 36, 38, 40, 41, 44, 45, 47, 51-53 and 55-59--Green/Yurek
Appellants argue claims 35, 36, 38, 40 and 47 as a group. We take
claim 35 as representative. Appellants separately argue the patentability of
claims 41, 44, and 45, which depend directly or indirectly from claim 35.1
Similarly, without identifying the claims in a separate subheading,
Appellants separately argue the patentability of claim 51 grouped with
claims 52, 53, and 55-59 depending therefrom. For this group of claims,
claim 51 is deemed representative.

1 The claims are not identified in separate subheadings, as recommended by
37 C.F.R. § 41.37(c)(1)(vii), however we were able to discern which
arguments were relevant to which claims.
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Appellants’ main arguments directed to claim 35 are that the Green
patent does not disclose a stent that is attached to a filter (App. Br. 8-11;
Reply Br. 3-6), that a person of ordinary skill in the art would not combine
the teachings of Yurek with Green in the manner proposed (App. Br. 12-13;
Reply Br. 8), and that Yurek does not disclose an infolded sleeve wherein a
portion of the inner layer is secured to a guidewire (App. Br. 12). Taking
the last of these contentions first, the Examiner maintains that the proposed
modification to Green’s device is to provide Green’s sleeve in an infolded
state (the infolded sleeve being taught by Yurek) such that the inner layer
would be secured to the delivery device, or guidewire, of Green. (Ans. 6).
We are not persuaded by Appellants’ argument, which is viewed as either an
individual attack on the Yurek reference or improper insistence on an exact
bodily incorporation of the teachings of Yurek into the Green device.
Appellants’ argument that persons of ordinary skill in the art would
not combine the teachings of Yurek and Green is based primarily on the
contention that one does not need the additional layer of sleeve material that
would result from employing an infolded sleeve as disclosed by Yurek on
the device of Green in order to deploy Green’s filter, and that the additional
sleeve thickness would result in an undesirably large delivery configuration.
(Reply Br. 8). The first contention does not address the consideration that a
person skilled in the art might wish to deploy the filter by peeling a flexible
sleeve from over the filter (see Ans. 4) rather than extracting the filter
through a more rigid sheath, as shown in Green. The latter contention
presupposes that the material of the infolded sleeve would be at least as thick
as the sheath disclosed in Green, whereas there is nothing to indicate that
that would be the case. Furthermore, even if a larger delivery configuration
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would result, a given course of action often has simultaneous advantages and
disadvantages, and this does not necessarily obviate any or all reasons to
combine teachings. See Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340,
1349, n. 8 (Fed. Cir. 2000).
Appellants’ arguments to the effect that Green does not disclose a
stent attached to a filter will be addressed with reference to Appellants’
Specification. Appellants describe that an “expansion means” is provided,
which, in its broadest sense, is “any device used to cause filter 60 to
expand.” (Spec., p. 7, ll. 1-2). Appellants’ “preferred expansion means is a
‘self-expanding stent’”, with that term being used in the Specification and
claims, “in its broadest sense as a plurality of arms which have a shape
memory expanded position wherein they are capable of contacting arterial
walls and supporting a filter such as filter 60 and which may be compressed
or folded against the guidewire 20 by radial forces applied against the arms.”
(Spec, p. 7, ll. 2-7).
Appellants frame the issue as
whether one of ordinary skill in the art would
understand that wire ends 174, filter basket wires
168, membrane 170, and wire ends 172 of Green
combine to form an art recognized filter as that
term is commonly used or whether the elements
would be understood to disclose or teach two
distinct structures, said respective structures
comprising a “stent”, . . . , and an attached filter.
(Reply Br. 3-4). In the absence of Appellants’ Specification, the Answer
might reasonably be the former. However, claim interpretation and
application of prior art to claim elements must be done not in the absence of
Appellants’ Specification, but instead in the context of Appellants’
Specification.
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Claim 35 calls for simply a “stent” attached to a “filter”. The claim
term “stent” clearly encompasses the disclosed and broadly defined “self-
expanding stent”, which is essentially a plurality of arms having certain
material characteristics.2 Appellants’ structure as illustrated in Figure 2 has
a plurality of expandable arms (a “self-expanding stent”) attached to a filter.
The structure disclosed in Figures 14 and 15 of Green is much the same, and
certainly includes a plurality of expanding arms (a “self-expanding stent”, as
defined by Appellants) attached to a filter membrane. It is Appellants’ own
description and definitions that informed the Examiner’s findings in this
respect, and we fail to see error in the manner in which the Examiner has
read claim 35 onto the Green structure.
Accordingly, the rejection of claim 35, as well as that of claims 36,
38, 40 and 47, as unpatentable over Green and Yurek, is sustained.
Appellants separately argue claim 41 essentially for the same reason
advanced with respect to claim 35, i.e., that the Examiner erroneously found
that the filter basket wires in Green comprise the claimed stent attached to a
filter. For the reasons discussed above, we sustain the rejection of claim 41
as unpatentable over Green and Yurek.

2 Appellants’ argument (Reply Br. 4) to the effect that the Examiner’s
reliance on the “stent” disclosed in Appellants’ Figure 2 is in error, because
the embodiment of Figure 2 is directed to a non-elected species, is not well
taken. Early on in prosecution, the Examiner identified, and Appellants
acknowledged, that claim 35 now at issue was generic to all species. (Ofc.
Action dated Jan. 30, 2007; Response to Restriction Requirement dated Feb.
21, 2007). Similarly, Appellants’ argument (id.) that the claimed “stent” is
“not necessarily self-expanding” is misplaced, and actually is tantamount to
an admission that the claim encompasses self-expanding stents, as defined in
the Specification.
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Claim 44, which depends from claim 35, and independent claim 51,
each contain a limitation that the guidewire include a mounting region
proximal the distal end of the emboli capture device, with the mounting
region having a cross-sectional profile which is less than the cross-sectional
profile of the guidewire, and that the filter be disposed about at least a
portion of the mounting region. (Appeal Br., Claims Appendix). Appellants
contend that the Green device does not include such features, and that the
Examiner’s reliance on two different embodiments in Green (one illustrated
in Figures. 14, 15 and 17, another illustrated in Figures 1, 4, 5A and 12) as
disclosing these elements is in error. (Appeal Br. 13-14; Reply Br. 7). We
here agree with Appellants.
The device illustrated in Figures 14, 15 and 17, principally relied on
by the Examiner as disclosing most of the claim limitations, has a guidewire
with a region of smaller cross-sectional dimension near a distal end of the
device, but there is no indication that the filter in that embodiment would be
disposed about a portion of that region, as required by the claims. The
embodiments of the device illustrated in Figures 1, 4, 5A and 12, for
example, do have a mounting region proximate the distal end, the cross-
section of which is less than the cross-section of the guidewire. However,
these embodiments operate in a different manner from the embodiment of
Figures 14, 15 and 17. In particular, the latter embodiment employs
radiopaque markers or crimp bands 176, 178, at least one of which is to be
slidable over core wire 164, in order for the filter and stent to expand and
contract. (Green, col. 7, ll. 58-67; Figs. 14, 15).
Given that this embodiment is not illustrated as having a mounting
portion of reduced cross-section about which the filter is disposed, and given
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that the transition from the reduced cross-section to the full cross-section of
the guide wire would appear to impede or prohibit the sliding of the slidable
crimp band, and further given the lack of any explanation by the Examiner
as to how features from other embodiments could be employed in the
embodiment of Figures 14, 15 and 17, we are persuaded that the Examiner’s
findings in this respect are in error. The rejection of claim 44, of claim 45
depending from claim 44, and of independent claim 51 and claims 52, 53
and 55-59 depending therefrom, is not sustained.
Claim 42--Green/Yurek/Simon
Appellants argue that the Simon reference does not overcome the
alleged deficiencies of Green, nor the alleged deficiencies of the
combination of teachings of Green with Yurek. (App. Br. 16). Essentially
all of the contentions are merely restatements of claim language found in
claim 35, from which claim 42 depends. (Id.). As noted supra, the
combination of teachings of Green and Yurek is not deficient with respect to
the obviousness of the subject matter of claim 35. Accordingly, we are not
persuaded that the Examiner erred in concluding that claim 42 is
unpatentable as well.
Claim 48--Green/Yurek/Ambrisco
Appellants argue that the Ambrisco reference does not overcome the
alleged deficiencies of Green, nor the alleged deficiencies of the
combination of teachings of Green with Yurek. (App. Br. 17). Essentially
all of the contentions are merely restatements of claim language found in
claim 35, from which claim 48 depends. (Id.). As noted supra, the
combination of teachings of Green and Yurek is not deficient with respect to
the obviousness of the subject matter of claim 35. Accordingly, we are not
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persuaded that the Examiner erred in concluding that claim 48 is
unpatentable as well.

CONCLUSIONS
The Examiner provided an articulated reason to combine the teachings
of Green and Yurek that is supported by rational underpinnings.
The Examiner did not err in finding that Green discloses a stent
attached to a filter.
The Examiner erred in finding that Green discloses a guidewire that
includes a distal mounting region having a cross-sectional profile less than
the guidewire cross-sectional profile, with a filter disposed about at least a
portion of the mounting region.

DECISION
The decision of the Examiner to reject claims 35, 36, 38, 40-42, 47
and 48 is affirmed. The decision of the Examiner to reject claims 44, 45, 51-
53 and 55-59 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)(1)(iv).
AFFIRMED-IN-PART

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