Ex Parte Hartley

Board of Patent Appeals and Interferences

Sep 1, 2009

10647642 (B.P.A.I. Sep. 1, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID ERNEST HARTLEY
__________

Appeal 2009-004204
Application 10/647,642
Technology Center 3700
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Decided: September 1, 2009
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving a claim to a stent
graft prosthesis. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-
in-part.

Appeal 2009-004204
Application 10/647,642

Statement of the Case
The Claims
Claims 1, 3, 4, 7-9, 11, 12, 15-19, and 22 are on appeal. Claims 1 and
3 have been argued separately. Claims 4, 7-9, 11, 12, 15-19, and 22 stand or
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
1. A stent graft prosthesis mounted to a deployment
device and adapted to be deployed in a curved lumen, the
curved lumen having an inner side and an outer side of the
curve, the deployment device including a guide wire
catheter, the stent graft prosthesis being temporarily
mounted to the deployment device at at least one end of the
prosthesis by a retention arrangement, the retention
arrangement including a retention of the stent graft
prosthesis to the guide wire catheter at a plurality of
retention points of the circumference of the proximal end of
the stent graft prosthesis, there being a greater
circumferential distance between two adjacent retention
points than other of the points, wherein the guide wire
catheter includes a trigger wire catheter coaxially around the
guide wire catheter with trigger wires passing along an
annular space between the guide wire catheter and the
trigger wire catheter and exiting through apertures in the
trigger wire catheter at the retention points and the trigger
wires are engaged with the graft material to provide the
retention points and the apertures are equally spaced around
the trigger wire catheter whereby when the deployment
device is deployed in the curved lumen the greater
circumferential distance is on the inner side of the curve.

3. A stent graft prosthesis mounted to a deployment
device as in Claim 1 wherein the retention arrangement
includes three retention points so that one larger and two
smaller folds of the graft material are formed.

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The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Chuter US 5,562,726 Oct. 8, 1996
Lau et al. US 5,873,906 Feb. 23, 1999

The issue
The Examiner rejected claims 1, 3, 4, 7-9, 11, 12, 15-19, and 22 under
35 U.S.C. § 103(a) as obvious over Lau and Chuter (Ans. 3-4).
The Examiner finds that “Lau discloses the invention substantially as
claimed being a stent graft coupled to a deployment device through trigger
wires that engage suture loops, which remain on the stent after deployment.
However, Lau does not disclose that the trigger wires exit the catheter
through separate apertures at the retention points” (Ans. 4). The Examiner
finds that
Chuter teaches the use of a graft and a delivery system
wherein the trigger wire is directed through two
apertures (236) equally spaced about the catheter just
prior to the engagement with the graft in the same
field of endeavor for the purpose of providing a
smooth path for both of the trigger wires to be moved
without obstructing each other.

(Ans. 4.)
The Examiner finds that “[i]t would have been obvious to one having
ordinary skill in the art at the time the invention was made to combine the
apertures taught by Chuter with the deployment device of Lau in order to
keep the trigger wires untangled and separate from each other allowing a
smoother release of the stent” (Ans. 4).
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Appellant contends that “the combination of Lau et al. and Chuter
fails to teach, either expressly or inherently, several of the elements recited
in the rejected claims” (App. Br. 7). Appellant also contends that the
Examiner “has combined the teachings of Lau et al. with Chuter. However,
he has not articulated any reason why this combination would have been
obvious” (App. Br. 9). Appellant also contends that “even if properly
combined, Chuter does not make up the deficiencies in Lau et al. Chuter
does not teach the differences in the circumferential distances at the
proximal end of the prosthesis that would produce uneven lobes, and prevent
a portion of the prosthesis to fold over during insertion” (App. Br. 9).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Has Appellant demonstrated that the Examiner erred in finding that
the combination of Lau and Chuter render claims 1 and 3 obvious?
Findings of Fact (FF)
1. Lau teaches “a foldable stent or stent-graft which may be
percutaneously delivered with (or on) a catheter, typically an endovascular
catheter, to a body cavity or lumen” (Lau, col. 1, ll. 12-14).
2. Figure 19 of Lau is reproduced below:

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“In FIG. 19A may be seen a percutaneous catheter assembly (314) which has
been inserted into a selected site . . . within a body lumen” (Lau, col. 17, l.
66 to col. 18, l. 1).
3. Lau teaches that the “stent (312) is folded about the guidewire
(319) and guidewire tube (318) held axially in place prior to deployment by
distal barrier (320) and proximal barrier (322)” (Lau, col. 18, ll. 1-4).
4. Figures 21 and 22 of Lau are reproduced below:

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“FIGS. 21 and 22 show front quarter views of folded stents or stent grafts
held in that folded position by a tether wire using a sack knot” (Lau, col. 8,
ll. 46-48).
5. Lau teaches that tetherwire 306 (shown in figure 19A) can be
considered a “trigger wire” as recited in the claims because “removal of the
tetherwire (306) from a portion of the loops (308) . . . partially expand[s] the
stent (312) onto the selected site (316)” (Lau, col. 18, ll. 8-10).
6. Lau teaches a plurality of retention points with a trigger wire,
noting that
the slip line has a fixed end (320) and a release end (322).
[L]oops of the slip line pass through the eyelets (324) on the
side of the stent fold associated with the fixed end (320) and
are held in place by eyelets (326) on the side of the stent fold
associated with the release end (322).

(Lau, col. 18, ll. 20-24.)
7. The Examiner finds that Lau teaches that “there is a greater
circumferential distance between the retention points as shown in the figure
below . . . the examiner maintains that the claims are broad enough to allow
the interpretation of the lower two small flaps of Lau to be considered a
single large lobe” (Ans. 6 (presenting an annotated version of Lau’s Figure
22)).
8. Figure 22 of Lau shows retention points 324 and 326 on the
upper side of the figure and unmarked retention points displayed at the
bottom of figure 22 through which wires 335 and 332 pass. Retention points
324 and 326 are at a greater circumferential difference relative to the
unmarked retention points than to each other (see FF 4).
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9. The Examiner finds that “Lau does not disclose that the trigger
wires exit the catheter through separate apertures at the retention points”
(Ans. 4).
10. Chuter teaches “a transluminal graft prosthesis that can be
safely and precisely positioned” (Chuter, col. 3, ll. 48-49).
11. Figure 23 of Chuter is reproduced below:

“FIG. 23 depicts a carrier” (Chuter, col. 6, l. 65).
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12. Chuter teaches that “[d]uring insertion, prosthesis 228 and its
associated catheter systems are compressed into the space between
introducer sheath 217 and carrier stem 220” (Chuter, col. 16, ll. 21-24).
13. Chuter teaches that “[a]s depicted in FIG. 23, two pairs of holes
235 and 236 traverse the outer catheter of the carrier stem, one pair at each
end of prosthesis 228” (Chuter, col. 16, ll. 25-27).
14. Chuter teaches that “small loops of suture 237 and 238 wind
around inner catheter 229 at this point, entering and exiting the lumen of
outer catheter 230 through the holes” (Chuter, col. 16, ll. 27-30).
15. Chuter teaches that “[t]hese sutures, as well as suture loops 239
and 240, also traverse some part of prosthesis 228, thereby attaching both
ends of the prosthesis to the central carrier. Loops 237-240 (and the
prosthesis) are released by removal of inner catheter 229” (Chuter, col. 16,
ll. 30-34).
16. Chuter teaches that “[i]t is important that the two loops of each
set do not cross, otherwise the resulting linkage will prevent release from the
central carrier despite removal of the inner catheter” (Chuter, col. 16, ll. 34-
37).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. Moreover, an “[e]xpress suggestion to substitute
one equivalent for another need not be present to render such substitution
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obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). As noted by the
Court in KSR, “[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton.” 550 U.S. at 421.
“[T]he PTO gives a disputed claim term its broadest reasonable
interpretation during patent prosecution.” In re Bigio, 381 F.3d 1320, 1324
(Fed. Cir. 2004). The court recognizes the fairness of reading claims broadly
“before a patent is granted [since] the claims are readily amended as part of
the examination process.” Burlington Indus., Inc. v. Quigg, 822 F.2d 1581,
1583 (Fed. Cir. 1987). “Thus, a patent applicant has the opportunity and
responsibility to remove any ambiguity in claim term meaning by amending
the application.” Bigio, 381 F.3d at 1324. Applying the broadest reasonable
interpretation to claims also “’serves the public interest by reducing the
possibility that claims, finally allowed, will be given broader scope than is
justified.’” In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed.
Cir. 2004).
Analysis
Claim 1
Lau teaches a stent graft and deployment device where the
deployment device includes a guide wire catheter (FF 1-3). Lau teaches that
the stent graft is mounted with a retention arrangement at a plurality of
retention points (FF 4-6). While Lau does not teach that the trigger wires
exit through apertures in the trigger wire catheter (FF 9), Chuter teaches a
catheter in which the trigger wires exit through such apertures to prevent
linkage or tangling (FF 10-16).
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Application 10/647,642

We are not persuaded by Appellant’s argument that “the configuration
of the tether wire of Lau et al. does not produce the ‘a greater
circumferential distance between two adjacent retention points than other of
the points’” (App. Br. 8). We note that claim 1 relates the retention points to
“other of the points” and imposes no further requirement on the
circumferential difference. Figure 22 of Lau shows retention points 324 and
326 on the upper side of the figure and unmarked retention points displayed
at the bottom of figure 22 through which wires 335 and 332 pass. Retention
points 324 and 326 are reasonably interpreted as being at a greater
circumferential difference relative to the unmarked retention points than to
each other (see FF 4, 6-8).
We are not persuaded by Appellant’s argument that “Lau et al.
discloses a tether wire that laces around the outside of the prosthesis, and is
not connected to a trigger wire catheter” (App. Br. 7). Appellant also
contends that the “circumferentially spaced points along the length of the
prosthesis in Lau et al. are connected to each other and not to a delivery
device” (App. Br. 7-8). We agree with the Examiner that claim 1 “never
recite[s] that the trigger wire is connected to the delivery device” (Ans. 4).
We also agree with the Examiner that the claim requirement is that “the
trigger wires passes through apertures in the delivery device” (Ans. 5). As
the Examiner correctly notes, the “modification of Chuter adds the apertures
to the delivery device of Lau in order to guide the trigger wires” (Ans. 5; FF
10-16). We think that the rejection clearly relies on Chuter to satisfy the
requirements for the location of the trigger wires “passing along an annular
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space between the guide wire catheter and the trigger wire catheter” (FF 10-
16).
We are also not persuaded by Appellant’s argument that “Lau et al.,
does not show the retention of the proximal end of the prosthesis by the
deployment device” (App. Br. 8). As Appellant acknowledges in the Reply
Brief, “Applicant agrees with the Examiner that the proximal end, as shown
in Lau, is actually the distal end” (Reply Br. 1-2). We agree with the
Examiner that the “wires extend distally to the back of the delivery device of
Lau” (Ans. 5), as shown in figure 22 of Lau (FF 4).
Finally, we are not persuaded by Appellant’s argument that the
Examiner “has not articulated any reason why this combination would have
been obvious” (App. Br. 9). The Examiner explained that “[i]t would have
been obvious to one having ordinary skill in the art at the time the invention
was made to combine the apertures taught by Chuter with the deployment
device of Lau in order to keep the trigger wires untangled and separate from
each other allowing a smoother release of the stent” (Ans. 4). The Examiner
provides a specific reason, including a motivation in Chuter for modifying
Lau with the apertures of Chuter, satisfying not only the requirements of
obviousness under KSR, but reasonably providing a specific motivation as
well.
Claim 3
Appellant argues that “dependent claim 3 further requires that the
retention arrangement include ‘three retention points so that one larger and
two smaller folds of the graft material are formed’” (App. Br. 10).
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Application 10/647,642

Appellant argues that Lau and Chuter do not disclose this element (see App.
Br. 10).
The Examiner finds that Lau teaches that “[t]he retention device forms
3 lobes. There are two small upper lobes formed by upper retention points
(324) and (326) and one large lower lobe shown in figure 22 and again in the
figure below for more clarity” (Ans. 3-4).
We think that Appellant has the better argument. Figure 22 of Lau
might reasonably be interpreted as showing four equal lobes or even as
showing two equal lobes (where the two sides were each lobes), but it is not
a reasonable interpretation of the figure to interpret the upper half as having
two lobes and the lower half as being composed of a single lobe. No other
evidence or reason to suggest that the “three retention points so that one
larger and two smaller folds of the graft material are formed” as claim 3
requires is presented. We therefore find that the combination of Lau and
Chuter does not render claim 3 obvious.
Conclusions of Law
(i) Appellant has not demonstrated that the Examiner erred in finding
that the combination of Lau and Chuter renders claim 1 obvious.
(ii) Appellant has demonstrated that the Examiner erred in finding that
the combination of Lau and Chuter renders claim 3 obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
103(a) as obvious over Lau and Chuter. Pursuant to 37 C.F.R.
§ 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 4, 7-9, 11,
12, 15-19, and 22, as these claims were not argued separately.
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Application 10/647,642

We reverse the rejection of claim 3 under 35 U.S.C. § 103(a) as
obvious over Lau and Chuter.
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)(2006).

AFFIRMED-IN-PART

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