Ex Parte Zilla et al

Patent Trial and Appeal Board

Mar 30, 2016

12482978 (P.T.A.B. Mar. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/482,978 06/11/2009
22476 7590 04/01/2016
HAUGEN LAW FIRM
SUITE 1130 - TCF TOWER
121 SOUTH EIGHTH STREET
MINNEAPOLIS, MN 55402
FIRST NAMED INVENTOR
Peter P. Zilla
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.
2009-4143.DIV 8283
EXAMINER
GHERE!, SUZETTE JAIME J
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
04/01/2016 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):
haugenmail@haugenlaw.com
kschmidt@haugenlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER P. ZILLA, NASSER RAFIEE, DEON BEZUIDENHOUT,
THOMAS FRANZ, MARK YEOMAN, HELLMUT BOWLES,
NAREAK DOUK, and MICHAEL F. WOLF
Appeal2014-001701
Application 12/482,978
Technology Center 3700
Before JOHN C. KERINS, GEORGE R. HOSKINS, and
BRANDON J. WARNER, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Peter P. Zilla et al. ("Appellants")1 appeal under 35 U.S.C. § 134 from
the Examiner's decision rejecting claims 1, 2, and 6 in this application. The
Board has jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 The Appeal Brief identifies Kips Bay Medical, Inc. as the real party in
interest. Appeal Br. 3.
Appeal2014-001701
Application 12/482,978
CLAIMED SUBJECT MATTER
Claims 1 and 6 are independent. Claim 1 illustrates the claimed
subject matter, and it recites:
1. A blood vessel graft comprising a flexible, fiber
mesh configured as a generally tubular external support and a
replacement blood vessel segment carried within and having an
ablumenal surface in contact with and supported by the tubular
support, the support having resilient radial expansion and
contraction characteristics that provide the graft with a
compliance ranging from 3 to 30%/100 mm Hg.
Appeal Br. 14 (Claims App.).
REJECTIONS ON APPEAL
Claim 1 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Dardik (US 3,974,526, iss. Aug. 17, 1976), Sowinski (US 2003/0009210 Al,
pub. Jan. 9, 2003), and Bezuidenhout (US 2003/0055494 Al, pub. Mar. 20,
2003).
Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Dardik, Sowinski, Bezuidenhout, and Lentz (US 6,428,571 Bl, iss. Aug. 6,
2002).
Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Dardik and Andersen (US 5,674,276, iss. Oct. 7, 1997).
ANALYSIS
A. Obviousness based on Dardik, Sowinski, and Bezuidenhout (claim 1)
We begin by resolving a claim construction dispute between
Appellants and the Examiner concerning the broadest reasonable
interpretation of the term "resilient" in claim 1.
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Application 12/482,978
Appellants contend '"resilient', as used in the present claims,
referenc[ es] a material characteristic of the claimed tubular support as
having a native force which seeks to recoil or spring back into shape after
bending, stretching, or being compressed." Appeal Br. 8 (emphases added);
Reply Br. 4-6. Thus, in Appellants' view, the claimed "resilient" material is
substantially equivalent to Sowinski's definition of an "elastic" material "as
a material which exhibits a tendency to rebound or assume its original
shape," and the force associated with such an inherent tendency. Appeal
Br. 8 (citing Sowinski iJ 27).
The Examiner, in the Final Office Action, agreed with Appellants'
claim construction. The Final Office Action states "an elastic material ... is
synonymous with the term resilient (as no special definition has been
provided by the applicants['] specification)." Final Act. 2-3 (emphasis
added). The Final Office Action further provides: "The term resilient in its
broadest dictionary definition is to spring back; or rebound and is
synonymous with the term elastic (see dictionary.com definition ... )." Id. at
3 (omitting Internet citation).
In the Answer, the Examiner instead distinguishes elasticity and
resiliency, such that"[ e ]lastic is defined in a narrower scope and resilient in
a broader scope." Ans. 5-6. The Examiner then, somewhat inexplicably, re-
states the "synonymous" analysis from the Final Office Action. Id. at 6.
We must first determine the broadest reasonable interpretation of
"resilient" which is consistent with Appellants' Specification, as it would be
interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). The specification "is always
highly relevant to the claim construction analysis," is usually dispositive,
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Application 12/482,978
and "is the single best guide to the meaning of a disputed term." Phillips v.
AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (citing Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). In this case,
Appellants and the Examiner do not discuss Appellants' Specification. In
particular, Appellants' alleged definition of resilient as referencing a native
force which seeks to recoil or spring back into shape is unsupported by
citation to Appellants' Specification. Appeal Br. 8; Reply Br. 4-6.
Our review of Appellants' Specification leads us to conclude that the
broader interpretation of "resilient" set forth in the Answer is in fact the
broadest reasonable interpretation. The Specification discusses how a
"radially-resilient[] tubular support" surrounds a vein segment so the
segment can function in much the same way as an artery, "without undue
bulging or aggravated mismatching phenomena leading to a graft failure."
Spec. 3: 12-16. That is, the resilient support provides a compliance to the
venous graft that mimics the compliance of an artery when subjected to the
higher blood pressures typically experienced by arteries as opposed to veins.
Id. at 2:6-18, 3:16-21, 4:6-15, 16:9-15. We do not find in Appellants'
Specification any suggestion that the resilient support must have a native
force which seeks to recoil or spring back into shape, in order to provide an
artery-like compliance.
Indeed, we must be cautious against reading limitations into a claim
from a preferred embodiment of a specification, absent a clear disclaimer.
In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1369. Appellants'
Specification indicates that, in some embodiments of the invention, the
claimed resilient support is formed of a "shape memory" material that "may
exhibit superelastic properties." Spec. 5:6-15, 16:15-16, 18:13-18. We
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Application 12/482,978
decline to read such a shape memory characteristic into the claim term
"resilient," as we do not find a clear disclaimer in Appellants' Specification
requiring us to do so. Thus, we disagree with Appellants' contention that the
claimed "resilient" material is substantially equivalent to an "elastic"
material that seeks to recoil or spring back into shape.
Appellants contend the Examiner errs in finding Sowinski's ePTFE2
material is "resilient" as required by claim 1. Appeal Br. 7-10. This
contention relies on Sowinski's disclosure that the ePTFE material "is able
to be elongated or expanded and then returned to its original state ...
without a substantial elastic force existing within the ePTFE material."
Sowinski iJ 27 (emphasis added); see Appeal Br. 7-10 (citing Sowinski
iii! 27, 38). That is, the contention relies on Appellants' narrow reading of
the claim term "resilient" to be substantially equivalent to "elastic." Having
found that reading to be unpersuasive for reasons provided above, we are
likewise unpersuaded by Appellants' argument that Sowinski' s ePTFE
material is not resilient. In particular, Sowinski's disclosure that the ePTFE
tubular structure has "physical recovery properties" providing "the ability to
expand and contract in accordance with the stent" covered by the ePTFE
material establishes that the ePTFE material is "resilient" as recited in
claim 1. Sowinski iii! 12-14; see also Appeal Br. 9-10 (discussing this
physical recovery property in Sowinski).
Moreover, even assuming that Appellants' narrow interpretation of
the claimed "resilient" material as requiring a native force which seeks to
recoil or spring back into shape is correct, the Examiner's finding that
2 "ePTFE" is short-hand for expanded polytetrafluoroethylene. See
Sowinski iii! 2, 6.
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Application 12/482,978
Sowinski discloses such a material is supported by a preponderance of the
evidence. In particular, the Examiner finds Sowinski discloses ePTFE
vascular grafts including "a textile comprising a resilient knit pattern (see
0050-0051 )." Final Act. 5 (emphasis added). The cited Sowinski disclosure
provides:
[0050] In a still further embodiment, an additional layer
may be added to a composite stent/ graft device which is not
extruded ePTFE. Preferably, the additional layer possesses
similar capabilities of longitudinal and radial expansion and
recovery. The additional layer may be a tubular textile graft,
such as ... a pattern of interlaced yams arranged in a resilient
knit pattern which permits longitudinal expansion or contraction
consistent with the longitudinal expansion or contraction of the
extruded ePTFE and/or stent. ...
Sowinski iJ 50 (emphases added); see also id. iJ 51. Appellants fail to
address the Examiner's finding that adding a "resilient knit pattern" layer to
the ePTFE material results in a "resilient" tubular structure as claimed. Final
Act. 5. We are, thus, not apprised of error in that finding.
Appellants further contend a person of ordinary skill in the art would
not modify Dardik's mesh support with Sowinski's resilient endolumenal
stent cover because the purpose of Sowinski' s stent cover is contrary to the
purpose of Dardik's mesh support. Appeal Br. 7. Specifically, according to
Appellants, Dardik's mesh "desirably allows for easy ingrowth of extrafibro-
collagenous tissue from outside the graft." Id. at 10 (citing Dardik, 3 :29-
31 ). Appellants contend that Sowinski, by contrast, teaches a stent cover for
intralumenal or endoscopic delivery "provided to reduce cell growth and
occlusions in the interior of the lumen." Id. (citing Sowinski iii! 2, 25).
Appellants thus contend those of ordinary skill in the art would not seek to
modify Dardik's mesh "to diminish ingrowth of tissue from outside the
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graft, which would be understood as the likely outcome of employing"
Sowinski' s material. Id.
We are not persuaded of Examiner error in determining it would have
been obvious to modify Dardik' s mesh tubular support, in light of Sowinski,
to provide resilient radial expansion and contraction characteristics. Final
Act. 5. This modification of Dardik's mesh does not require the bodily
incorporation of Sowinski' s particular resilient ePTFE material, which
"reduce[ s] cell growth and occlusions" (Sowinski ,-i 2), if such a property
would be undesirable in Dardik. See In re Keller, 642 F.2d 413, 425 (CCPA
1981) (obviousness does not require all of the features of a secondary
reference to be bodily incorporated into a primary reference).
For the foregoing reasons, we are not persuaded of Examiner error in
rejecting claim 1 as unpatentable over Dardik, Sowinski, and Bezuidenhout,
and we sustain that rejection.
B. Obviousness based on Dardik, Sowinski, Bezuidenhout, and Lentz
(claim 2)
Claim 2 depends from claim 1. Appellants contend the rejection of
claim 2 as unpatentable over Dardik, Sowinski, Bezuidenhout, and Lentz
should be reversed because Lentz fails to cure the defects of Dardik,
Sowinski, and Bezuidenhout as to claim 1. Appeal Br. 11. Having
determined there are no defects to cure as to claim 1, we likewise sustain the
rejection of claim 2.
C. Obviousness based on Dardik and Andersen (claim 6)
Appellants contend the Examiner errs in finding Andersen discloses
or suggests a graft with a tubular support "having resilient radial expansion
and contraction characteristics that provide the graft with compliance
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Application 12/482,978
properties mimicking those of an artery," as recited in claim 6 (emphases
added). Appeal Br. 13. For the following reasons, we agree.
The Examiner's rejection of claim 6 begins by stating "Dardik et al.
supra however Dardik et al. does not disclose that the support comprises a
flexible, resilient knit wire mesh." Final Act. 6-7; see also id. at 4-5 (citing
Dardik 4:9 and 4:43--48 in connection with claim 1 ). That statement fails to
notify Appellants (or the Board) which limitations in claim 6 the Examiner
finds to be disclosed, or not disclosed, in Dardik. The rejection then cites
Andersen as disclosing vascular grafts "constructed and knitted from an
elastic (which equates to resilient) metal wire." Id. at 7. It appears,
therefore, that the rejection of claim 6 finds Dardik fails to disclose at least
the claimed "resilient" mesh, which is consistent with the rejection of
claim 1. If Dardik is missing a resilient mesh, then Dardik is also missing
"resilient ... characteristics that provide the graft with compliance
properties mimicking those of an artery," as further required by claim 6. 3
The Examiner's citation to Andersen does not cure that deficiency in
Dardik. The Examiner cites Andersen, column 3, lines 6-10, as "teach[ing]
that vascular grafts may be constructed and knitted from an elastic (which
equates to resilient) metal wire." Final Act. 7. The cited disclosure
describes anchoring end portions 14, 14' of graft 10 being formed of an
"elastic metal strand capable of being reduced in radial size without plastic
deformation and retaining self-restoring capability such that ... when freed
3 Dardik discloses surrounding either an artery or a vein with a wire mesh,
for use as both arterial and venous substitutes. Dardik, 1:65-2:13, 2:36--42.
If the Examiner intended to rely on Dardik's disclosure of using an artery as
a graft, the rejection fails to notify Appellants of such intent. See Final
Act. 4, 7.
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can radially self-expand to tubular form to engage the wall of the lumen."
Andersen, 3:6-13, 4:50-51, Fig. 1. The Examiner fails to provide findings
or technical reasoning that would indicate such a resilient expansion of end
portions 14, 14' provides compliance properties "mimicking those of an
artery," as recited in the claim.
For the foregoing reasons, we are persuaded of Examiner error in
rejecting claim 6 as unpatentable over Dardik and Andersen, and we do not
sustain that rejection.
DECISION
The Examiner's decision to reject claims 1, 2, and 6 as unpatentable
over the prior art is affirmed as to claims 1 and 2, and reversed as to claim 6.
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-IN-PART
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