Ex Parte Biggs et al

Patent Trial and Appeal Board

Feb 5, 2015

12233359 (P.T.A.B. Feb. 5, 2015)

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.
12/233,359 09/18/2008 DAVID P. BIGGS 12730-423 PA-6355-RFB 1994
48003 7590 02/05/2015
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
02/05/2015 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID P. BIGGS, JICHAO SUN,
and ALAN R. LEEWOOD
__________

Appeal 2012-007472
Application 12/233,359
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to an
endoluminal prosthesis. The Examiner rejected the claims as anticipated.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 Appellants identify the Real Parties in Interest as Cook
Incorporated and Med Institute, Inc. (see App. Br. 3).
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2
Statement of the Case
Background
“The present invention provides a stent graft for endoluminal
implantation. The stent graft is adapted to telescopically receive a secondary
stent graft and is characterized in that the stent graft comprises at least one
socket communicating with at least one opening in the stent graft” (Spec. 3
¶ 10).
The Claims
Claims 1–16 are on appeal. Independent claim 1 is representative and
reads as follows:
1. An endoluminal prosthesis comprising:
a tubular graft having a proximal end, a distal end, a
lumen therethrough, and an opening between the proximal
end and distal end; and an evertible elastic socket disposed
within the lumen of the tubular graft,
the elastic socket comprising a socket wall, a first end,
a second end, and a lumen therethrough, an everted
configuration and extended configuration, where the first
end of the socket is disposed adjacent the opening of the
tubular graft in the everted and extended configurations, and
the second end is disposed in the lumen of the graft in the
everted configuration and is disposed external to the graft in
the expanded configuration.

The issue
The Examiner rejected claims 1–16 under 35 U.S.C. § 102(b) as
anticipated by Laguna2 (Ans. 4–6).

2 Laguna, A., WO 03/065933 A1, published Aug. 14, 2003.
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The Examiner finds that
Laguna discloses a prosthesis that includes a tubular graft
(104) with a side opening (204) and an evertible elastic
socket (106) disposed within the lumen of the graft. The
first end of the evertible graft is attached to the side opening
(page 10, line 33 to page 11, line 1). The second end of the
socket (106) moves from a position within the graft (see
Figure 9) to a position external to the graft (see Figures 1, 7,
and 8).

(Ans. 4).
The Examiner finds that Laguna teaches “that the socket may be
constructed of polyurethane (see description for side branch member in lines
8-13 on page 10), which is considered to meet the requirement of ‘elastic
socket’” (Ans. 4). The Examiner finds that the “term ‘elastic’ was
interpreted in light of Applicant’s specification, which discloses that
polyurethane is a material with sufficient elasticity, deformability, and
biocompatibility for forming the socket” (Ans. 4).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Laguna anticipates the
claims?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Laguna teaches that a “side-branch member 106 is connected to
the main member 104 to allow fluid flow between the two components”
(Laguna 10, ll. 32–33).
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2. Laguna teaches that a side-branch graft “may be constructed
from one or more of a variety of suitable materials, such as, but not limited
to . . . polyethylene, polytetrafluoroethylene, polyurethane and the like. . . .
In the present embodiment, the side-branch graft . . . includes a thin, strong,
flexible, and/or kink resistant material” (Laguna 10, ll. 8–12).
3. Laguna teaches that “the side-branch stent 112 may be installed
separately, after the side-branch member 106 has been otherwise pushed or
pulled from inside the main member 104” (Laguna 14, ll. 32–34).
4. The Specification teaches that:
The socket 30 can comprise Thoralon which demonstrates
significant elasticity (approximately 900%) so as to provide
a wide range of operation. Alternatively, one skilled in the
art can see a wide range of materials may be used herein,
which includes ePTFE, polyurethane, and any other
polymers which exhibit sufficient elasticity and/or
deformability and, of course, biocompatibility.

(Spec. 13 ¶ 55).
5. Laguna teaches that:
The tube, however, having undergone some recoil, did not
fit onto the 4mm mandrel. . . . The section of the tube, which
was distended to a 4mm inner diameter, fit over the 3.8mm
mandrel easily, indicating that the inner diameter of the tube
was then approximately 3.8mm. Thus, the distended
diameter of the tube was 4mm and the recoil diameter of the
tube was approximately 3.8mm, resulting in a recoil value of
approximately 0.2mm. Dividing the approximate recoil
value of 0.2mm by the distended diameter of 4mm, and
converting to a percentage yields a percent recoil value of
approximately 5 percent.

(Laguna 36, ll. 14–21).
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6. Figure 7 of Laguna is reproduced below:

“Figure 7 is a cross-sectional view of an exemplary embodiment of a
prosthetic conduit, with the distal end of the main member inflated with a
balloon catheter and the side-branch member partially pushed out from
within the main member” (Laguna 4, ll. 19–21).
7. Laguna teaches that a “stent . . . is then placed within the
annular space between the everted section and the underlying graft
component, the end of the side-branch stent 112 abutting the fold at the end
of the everted section of the graft component” (Laguna 26, ll. 11–18).
8. Laguna teaches that the “proximal end 308 may further include
a mechanism, such as the attachment area including the flange 304, for
facilitating attachment of the side-branch member 106 to the side opening
204 of the main member 104” (Laguna 11, ll. 6–8).
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Principles of Law
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. See In re Sneed, 710 F.2d 1544, 1548
(Fed. Cir. 1983).
Analysis
Claim 1
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation in
dispute is the requirement for an “elastic socket” in claim 1. Appellants
contend that:
The Examiner is not correct for at least four reasons: 1)
Appellants’ specification does not give any particular
meaning to the term elastic, and hence that term must be
construed based on its ordinary meaning; 2) Laguna never
discloses that its side branch is elastic or that the materials it
is made from are elastic; 3) the Examiner has not shown that
the materials disclosed in Laguna are inherently elastic and,
indeed, cannot; and 4) Laguna actually teaches that its side
branch is not elastic and hence teaches away from the
claimed invention.

(App. Br. 11).
The Examiner finds, based upon Appellants’ Specification, that the
“term ‘elastic’ is not construed as requiring any particular degree of
elasticity or other material properties of a particular polymer” (Ans. 8). The
Examiner finds that “nowhere in Applicant’s specification or claims is the
socket described as returning to its original length, shape, etc.” (Ans. 7).
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We find that the Examiner has the better position. “[D]uring patent
prosecution when claims can be amended, ambiguities should be recognized,
scope and breadth of language explored, and clarification imposed.” In re
Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Here, the ambiguity at issue is
how much elasticity is required to satisfy the requirement for an “elastic
socket” in claim 1. As the Examiner notes and Appellants acknowledge, the
Specification neither defines the term “elastic” nor provides a test for
determining how much elasticity is required for an “elastic socket” (cf. Ans.
7; App. Br. 12). The only requirement expressly present in the Specification
is for “polymers which exhibit sufficient elasticity” (Spec. 13 ¶ 55; FF 4).
We also find that there are multiple definitions of the term “elastic” in
the same dictionaries cited by Appellants other than the specific definition
cited by Appellants of “capable of returning to its original length, shape,
etc., after being stretched, deformed, compressed, or expanded” (App. Br.
12). Dictionary.com3 also defines “elastic” as “springing back or
rebounding; springy.” Merriam-Webster’s4 online dictionary gives an
alternative definition of “elastic” as “capable of ready change or easy
expansion or contraction : not rigid or constricted.”
Thus, the term “elastic” may be interpreted more broadly than
returning to an original shape, and also be interpreted as an adjective that
modifies the socket material to incorporate characteristics such as being
springy or capable of ready change as in the alternative dictionary
definitions. See In re Morris, 127 F.3d 1048, 1054-56 (Fed. Cir. 1997)

3 http://dictionary.reference.com/browse/elastic?s=t
4 http://www.merriam-webster.com/dictionary/elastic
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(“Absent an express definition in their specification, the fact that appellants
can point to definitions or usages that conform to their interpretation does
not make the PTO’s definition unreasonable when the PTO can point to
other sources that support its interpretation.”)
We, therefore, find that the broadest reasonable interpretation of the
term “elastic”, in light of the absence of any limiting definition in the
Specification and the multiple dictionary definitions, is a requirement for
some degree of springiness or expansion and contraction.
We next address Appellants’ contention that “Laguna does not
expressly or inherently disclose an elastic socket. . . . Laguna clearly does
not explicitly disclose that its side branch is ‘elastic’ within the ordinary
meaning of that term” (App. Br. 12-13). Appellants also contend that
elasticity is not inherent and that “the Examiner has provided nothing that
demonstrates that these materials are always or necessarily elastic” (App. Br.
13).
Laguna teaches that the side-branch graft material may be composed
of polytetrafluoroethylene or polyurethane and includes a “flexible” material
(FF 2). This material closely compares to the Specification, which teaches
that the socket may be composed of “a wide range of materials” which
include “ePTFE [polytetrafluoroethylene], polyurethane, and any other
polymers which exhibit sufficient elasticity and/or deformability” (Spec. 13
¶ 55; FF 4).
While the use of identical materials by Laguna and the Specification
does not necessarily support a finding of inherency, as correctly noted by
Appellants, Laguna specifically demonstrates that when a tube with 1.2 mm
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diameter was distended to 4 mm, the tube experience a recoil value
calculated by Laguna at 5 percent (FF 5). This express evidence does
support a finding that Laguna’s tube demonstrates some amount of elasticity,
consistent with the Examiner’s position that the “term ‘elastic’ is not
construed as requiring any particular degree of elasticity” (Ans. 8). That is,
the Examiner reasonably relies upon the broadest reasonable interpretation
of the term “elastic” as encompassing Laguna’s socket material that is at
least somewhat “springy” and “capable of ready change” based upon having
some recoil after distention (FF 5).
Appellants contend that “Laguna actually teaches away from using
elastic materials for its side branch” (App. Br. 14). Appellants contend that
“[a]lthough Laguna discloses that its branch member may be ‘distensible’
(capable of being distended) but with little or no recoil, this is not the same
as elastic (capable of recovering original shape and size after deformation)”
(App. Br. 14).
We have already addressed the claim interpretation of “elastic”,
finding that Laguna’s recoil reasonably satisfies this requirement. Further,
we note that the Federal Circuit has determined that “[t]eaching away is
irrelevant to anticipation.” Seachange Int’l, Inc., v. C-COR, Inc., 413 F.3d
1361, 1380 (Fed. Cir. 2005) (citing Celeritas Tech., Ltd. v. Rockwell Int’l
Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998).
Claims 2 and 16
Appellants contend that “Laguna does not disclose a stent that is at
least partially encased within the wall of an elastic socket, as recited by
claim 16” (App. Br. 15). Appellants contend that “Figure 7 is at best
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ambiguous as to what it discloses as there is absolutely no disclosure that the
stent is encased in the wall of an elastic socket” (App. Br. 15). Appellants
similarly argue the same limitation for claim 2 (App. Br. 16).
The Examiner responds that “Laguna explicitly discloses that the side
branch stent (112) is fully encased within the wall of the socket (106) (page
26, lines 11-28). A stent (112) is clearly illustrated between two layers of
graft material in Figure 7” (Ans. 9).
We find that the Examiner has the better position. Laguna teaches
that the stent 112 is placed within an annular space in the side-branch
member 106 (FF 6-7). We agree with the Examiner that the placement of
the stent into this annular space reasonably satisfies the requirement of claim
16 for a stent “at least partially encased within the socket wall” where
“encased” is interpreted to mean that the stent is at least partially covered on
both sides by socket wall material.
Claim 4
Appellants contend that “[c]laim 4 recites a socket, a stent and the
additional feature that the socket comprises fibers. For this reason also,
Laguna does not anticipate claim 4” (App. Br. 17).
The Examiner finds that “[t]he stent (112) encased within the socket
(106) comprises fibers of nitinol (page 9, line 31). Laguna states that the
socket can be formed from braided fibers and the material can be
polyethylene (page 10, lines 8-21). The stent (112) is considered to be an
integral part of the socket, since it is encased within its wall, so its fibers
meet the requirements of claim 4” (Ans. 5).
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We find that Appellants have the better position. While Laguna does
teach the use of polyethylene as a material for the socket (FF 2), and teaches
that the socket can take the form of braided tubing (Laguna 10, l. 20), the
Examiner does not identify a specific teaching of polyethylene fibers, as
required by claim 4. In addition, while Laguna teaches that the stent can be
made of nitinol (Laguna 9, l. 31), it does not refer to nitinol fibers. In any
case, the stent and socket are two different components, and a requirement
that the socket comprise fibers is not reasonably satisfied by a stent
composed of nitinol fibers.
Claims 9, 11, and 14
For these claims, Appellants contend that the “Examiner fails to
identify where Laguna discloses this element” (App. Br. 17).
The Examiner finds that “[r]egarding claim 9, the side wall of the
socket meets the requirement of graft material” (Ans. 5). The Examiner
finds that:
Regarding claim 11: the language “adapted for receiving a
secondary stent graft” is not a positive recitation of a second
stent-graft, but a functional recitation that is not given full
patentable weight. The prior art is not required to disclose a
second stent graft, but merely have the capability of
receiving one. Since the socket of Laguna has an open distal
end in communication with its lumen, it is capable of
receiving another stent-graft.

(Ans. 6). The Examiner finds that, based on similar reasoning, Laguna’s
socket “is capable of receiving another prosthesis after it has been deployed
in a branch artery” (Ans. 6).
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We find that the Examiner has the better position. The Examiner
provides reasoning explaining why claims 9, 11, and 14 are anticipated by
Laguna, while Appellants simply dispute this reasoning without any rebuttal
logic or evidence.
Claim 13
Appellants contend that “Laguna discloses the use of a balloon to
evert the side branch and not a guidewire” (App. Br. 18).
The Examiner finds that “[r]egarding claim 13, a guide wire (410) is
provided for guiding the socket into the branch artery (see Figures 4, 6, 7,
and 10)” (Ans. 6).
We find that the Examiner has the better position. Claim 13 is an
apparatus claim, not a method claim for everting the side branch. Laguna’s
Figure 7 shows a guidewire 410 associated with the endoluminal prosthesis
(FF 6). See, e.g., Catalina Marketing International, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 810 (Fed. Cir. 2002) (“[D]isputed
preamble language does not limit Claim 1 - an apparatus claim. To hold
otherwise would effectively impose a method limitation on an apparatus
claim without justification”).
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Claim 15
Appellants contend that “Laguna does not disclose a ring around the
opening of the main device body, but a flange on the side branch” (App. Br.
18).
The Examiner finds that “there is a flange (304), or reinforcing ring,
about the opening (204) for providing a fluid tight seal (Figure 3; page 11,
lines 6-13)” (Ans. 6).
We find that the Examiner has the better position. Claim 15 requires a
“reinforcing ring around the opening” where antecedent basis for “the
opening” reasonably refers to “a tubular graft having . . . an opening
between the proximal and distal end” in claim 1. Thus, “the opening” at
issue in claim 15 is the opening connecting the side branch to the main
member of the graft. Laguna teaches that the “proximal end 308 may further
include a mechanism, such as the attachment area including the flange 304,
for facilitating attachment of the side-branch member 106 to the side
opening 204 of the main member 104” (Laguna 11, ll. 6–8; FF 8). Thus,
Laguna expressly teaches a flange, which reads on a “reinforcing ring
around the opening” as required by claim 15.
Conclusion of Law
The evidence of record support the Examiner’s conclusion that
Laguna anticipates claims 1, 2, 9, 11, and 13–16.
The evidence of record does not support the Examiner’s conclusion
that Laguna anticipates claim 4.
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SUMMARY
In summary, we affirm the rejection of claims 1, 2, 9, 11, and 13–16
under 35 U.S.C. § 102(b) over Laguna. Pursuant to 37 C.F.R. § 41.37(c),
claims 3, 5–8, 10, 12, and 17–20 fall with claim 1, as these claims were not
argued separately.
We reverse the rejection of claim 4 under 35 U.S.C. § 102(b) over
Laguna.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART
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