Ex Parte Wang et al

Board of Patent Appeals and Interferences

May 4, 2012

10894946 (B.P.A.I. May. 4, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LIXIAO WANG and JOHN JIANHUA CHEN
__________

Appeal 2012-007295
Application 10/894,946
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, 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 claims to a medical
balloon and stent. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
The Specification teaches “the present invention is directed to a stent
delivery system employing a unique stepped compliant balloon which is
shaped to retain a stent about a stent mounting region of the balloon prior to
and during stent delivery” (Spec. 6, l. 31 to 7, l. 2). According to the
Specification, the “balloon is capable of providing low pressure predilation
at a relatively small diameter to open the lesion sufficiently to allow
insertion and deployment of the stent across the lesion and for subsequent
high pressure embedding of the stent in the vessel wall” (Spec. 7, ll. 2-5).
The Claims
Claims 34-37, 39, 40, 42-48, and 50 are on appeal. Claims 34, 36,
and 50 are representative. Claim 34 reads as follows:
34. A medical balloon and stent comprising:
a balloon including a stent mounting region and a pair of
adjacent end regions, the balloon being configured to inflate from
a first inflation state to a second inflation state, in said first
inflation state, said stent mounting region being unfolded and
having a diameter less than that of said adjacent end regions;
said stent mounting region having a predetermined rate of
expansion and said adjacent regions having a reduced rate of
expansion, said predetermined rate of expansion being greater
than the reduced rate of expansion, wherein said balloon is
inflated from the first inflation state to said second inflation state
by a predetermined inflation pressure, in said second inflation
state, the diameter of the stent mounting region is at least as large
as the diameter of said adjacent end regions; and
an expandable stent disposed about said stent mounting
region, said stent having an unexpanded outer diameter less than
or equal to the outer diameter of said adjacent end regions in said
first inflation state; and retractable stent retaining sleeves.
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The Issues
A. The Examiner rejected claims 34-37, 39, 40, 42-47, and 50 under 35
U.S.C. § 103(a) as obvious over Crocker,
1
Ryan,
2
and Alt
3
(Ans. 5-10).
B. The Examiner rejected claim 48 under 35 U.S.C. § 103(a) as obvious
over Crocker, Ryan, Alt, and Wang
4
(Ans. 10-11).
A. 35 U.S.C. § 103(a) over Crocker, Ryan, and Alt
The Examiner finds that “Crocker discloses the claimed device except
for in the first inflation state said stent mounting region inside surface
having a diameter less than that of said adjacent end regions, or said
expandable stent having an unexpanded diameter less than the outer
diameter of adjacent end regions in the first inflation state” (Ans. 7). The
Examiner finds that Alt teaches “a stent 20 having an unexpanded outer
diameter less than the outer diameter of adjacent end regions 23, 24 in the
first inflation state” (Ans. 7). The Examiner finds the combination of Alt and
Crocker obvious to “effectively assure retention of the stent during
movement of the delivery system without interference with deployment of
the stent” (Ans. 7).
Appellants contend that “Alt does not specify whether the balloon
membrane 18 of the device thereof is unfolded or folded. In light of the
foregoing, the Examiner‟s assertion- that the balloon membrane 18 is
unfolded - lacks factual support” (App. Br. 13). Appellants contend that the
“combination of the Crocker and Alt references, as proposed by the

1
Crocker et al., US 5,843,116, issued Dec. 1, 1998.
2
Ryan et al., US 5,108,416, issued Apr. 28, 1992.
3
Alt, E., US 6,027,510, issued Feb. 22, 2000.
4
Wang et al., US 5,738,901, issued Apr. 14, 1998.
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Examiner, would not be expected to yield a device as claimed. Moreover, it
is unclear that the Examiner‟s proposals are supported by the respective
specifications” (App. Br. 15).
Appellants contend that “[a]lthough the Examiner relies on Crocker to
disclose „an “unfolded stent mounting region” (30) in a first inflation state,‟
the skilled artisan would not be expected to combine the alleged unfolded
stent mounting region of Crocker with the potentially folded balloon of Alt.
It is unclear how this would even be accomplished” (App. Br. 16).
The Examiner responds that the rejection
relies on Alt to teach an unfolded stent mounting region 18
having an inside surface with a diameter less than that of
adjacent end regions 23 in a first inflation state. The claims
do not recite that the balloon must have a folded
configuration, but rather that at a first inflation state the stent
mounting region is unfolded, or does not have folds, and
therefore the cited references do not necessitate the
disclosure of a folded state in the balloons, but rather
necessitates the disclosure of a balloon without folds in a
first inflation state in the stent mounting region.

(Ans. 11-12).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that the combination of Crocker and Alt
render claims 34, 36, and 50 obvious?
Findings of Fact
1. Crocker teaches
an elongate flexible tubular body having an inflatable
balloon thereon, the balloon inflatable to a first diameter at a
first inflation pressure to produce a generally cylindrical
balloon profile, and proximal and distal portions of the
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balloon are additionally inflatable to a second, larger
diameter at a second, greater inflation pressure. An
expandable tubular graft is positioned on the balloon, and
the balloon is thereafter positioned within a body lumen
adjacent a treatment site.

(Crocker, col. 2, ll. 43-51).
2. Figure 2 of Crocker is reproduced below:

“FIG. 2 is a partial cross-sectional view of a preferred embodiment of the
variable diameter inflation catheter” (Crocker, col. 3, ll. 1-2).
3. Crocker teaches that “[d]epending upon the etiology of the
underlying condition, the central region of the stent may preferentially be
inflated to a larger diameter than either of the axial ends of the stent”
(Crocker, col. 15, ll. 8-11).
4. Crocker teaches that “[a]lternatively, the axial length of the
stent is selected to approximately equal the axial length of the focal zone on
the inflation balloon. In this manner, the inflation balloon within the stent is
expandable to a diameter slightly larger than the native diameter of the
adjacent vessel” (Crocker, col. 15, ll. 11-16).
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5. Table 2 of Crocker is reproduced below:

Table 2 of Crocker shows the inflation pressure profile of inflation balloon
18 (see Crocker, col. 10, ll. 10-30).
6. Figure 5 of Alt is reproduced below:

“FIG. 5 is a side view . . . with the stent illustrated fully in position and
tightly crimped on the balloon between the bumps at either side of the
balloon” (Alt, col. 4, ll. 54-57).

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7. Figure 1 of Alt is reproduced below:

“FIG. 1 is a perspective view of a portion of a stent delivery system . . .
exploded to show the stent being moved toward its position on the balloon
but not yet in place” (Alt, col. 4, ll. 41-44).
8. Alt teaches that:
the critical aspect of the bumps 23 and 24 is that they be
sufficiently sized and shaped to retain the stent 20 in place
on the balloon 12 without likelihood that the stent will be
dislodged, while the delivery system is being advanced to
(or retracted from) the target site in the vessel; and also to
allow the delivery system to be moved through the smallest
diameter vessel in the path to the target site with adequate
protection to avoid or reduce the likelihood of the stent
cutting, scraping or binding against the vessel wall.

(Alt, col. 5, ll. 48-56).
9. Alt teaches that “mounting balloon 12 is selectively fully
inflated via duct 17, thereby causing the stent to undergo radial expansion
until its outer surface engages the tissue at the inner surface of the wall 33 of
artery 35 at the target site” (Alt, col. 8, ll. 14-17).
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10. Ryan teaches that “[e]nd cap 26 has a mounting sleeve 32
attached to the catheter shaft at a region adjacent the proximal end of balloon
20” (Ryan, col. 6, ll. 12-14).
11. Ryan teaches that after balloon inflation, the “interior diameter
of the expanded stent, however, is greater than the outer diameter of the end
caps or balloon when the balloon is deflated, and this configuration allows
the delivery catheter to be withdrawn from the stent without causing the
stent to be moved from its expanded position” (Ryan, col. 6, ll. 55-62).
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. 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.
Analysis
We agree with the Examiner‟s fact finding, statement of the rejection
and responses to Appellants‟ arguments as set forth in the Answer.
Claim 34
Appellants contend that “Alt does not specify whether the balloon
membrane 18 of the device thereof is unfolded or folded. In light of the
foregoing, the Examiner‟s assertion- that the balloon membrane 18 is
unfolded - lacks factual support” (App. Br. 13). Appellants cite to Ex parte
Mallis, Appea12008-2420 BPAI (2009) for the proposition that a “rejection
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could not be sustained where the cited reference lacked adequate disclosure
to determine whether the particular element(s) of the claim were satisfied”
(App. Br. 14).
We are not persuaded. While Appellants are correct that the text of
Alt does not indicate whether the balloon is folded or unfolded (and in fact
appears to never uses the word “fold”), Figure 1 of Alt clearly shows the
stent being placed on top of balloon 12 and balloon membrane 18 (FF 7).
The balloon 12 in Figure 1 is clearly shown in an unfolded state (FF 7). In
addition, the Examiner finds that Figure 2 of Crocker also shows the balloon
in an unfolded state (FF 2; Ans. 11). We therefore conclude that the current
facts differ from Mallis since both of the cited references show that the
“unfolded” requirement of claim 1 was satisfied.
Appellants contend that the “combination of the Crocker and Alt
references, as proposed by the Examiner, would not be expected to yield a
device as claimed. Moreover, it is unclear that the Examiner‟s proposals are
supported by the respective specifications” (App. Br. 15).
We are not persuaded. Crocker teaches a balloon and stent which is
configured to inflate from a first inflation state to a second inflation state (FF
1), where in the second inflation state “the central region of the stent may
preferentially be inflated to a larger diameter than either of the axial ends of
the stent” (Crocker, col. 15, ll. 8-11; FF 3). Alt discloses a medical balloon
and stent with a pair of adjacent end regions where the stent begins with an
unexpanded out diameter less than the outer diameter of the adjacent end
regions (FF 6-8).

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We agree with the Examiner that the ordinary artisan would have
reasonably modified Crocker‟s balloon and stent, which are configured to
inflate from a first to a second inflation state (FF 1-4) with Alt‟s larger
adjacent end regions or bumps which are “sufficiently sized and shaped to
retain the stent 20 in place on the balloon 12 without likelihood that the stent
will be dislodged, while the delivery system is being advanced to (or
retracted from) the target site in the vessel” (Alt, col. 5, ll. 49-52; FF 8).
Both Crocker and Alt teach that the fully inflated balloon may be as large or
larger than the adjacent end regions (FF 3, 9). There is no dispute that Ryan
suggests the use of retractable stent retaining sleeves (FF 10-11).
Appellants contend that “[a]lthough the Examiner relies on Crocker to
disclose „an “unfolded stent mounting region” (30) in a first inflation state,‟
the skilled artisan would not be expected to combine the alleged unfolded
stent mounting region of Crocker with the potentially folded balloon of Alt.
It is unclear how this would even be accomplished” (App. Br. 16).
As we already noted, Alt‟s disclosure in Figure 1 demonstrates that
the balloon is unfolded. In Crocker and Alt, there is a teaching that a stent is
crimped onto a balloon prior to full inflation of the balloon (FF 1-9). 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. We agree with the
Examiner that only ordinary creativity would have been required to modify
the balloon and stent of Crocker to utilize the retaining bumps of Alt to
retain the stent in the first inflation state prior to installation of the stent in
the second inflation state (see, e.g., Ans. 7).

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Claim 50
Appellants contend that “none of Crocker, Alt, or Ryan, whether
considered independently or in combination, disclose, teach, suggest, or
otherwise render obvious a stent mounting region being unfolded and having
an inside surface with a diameter less than that of the adjacent end regions,
as claimed” (App. Br. 17).
We are not persuaded. As we discussed above, the figures in both
Crocker and Alt show unfolded balloons, which satisfies the requirements of
claims 34 and 50 (FF 2, 6, 7).
Claim 36
Appellants contend regarding the data plot of Table 2 of Crocker that
“these lines are not properly characterized as „generally collinear.‟” (App.
Br. 20).
We are not persuaded. Claim 36 requires a “stepped compliance
curve” which is “generally collinear with a corresponding segment of said
substantially linear compliance curve of said end regions”. Table 2 of
Crocker discloses a linear increase in the diameter of the central segment of
the balloon as pressure increases, with a stepped increase in the diameters of
the proximal and distal segments which is “generally collinear” with the
increase of pressure.
As we interpret claim 36, there is no requirement that the compliance
curve of the corresponding segments is precisely linear, but only that the
compliance curve is “generally collinear” with the central segment. The
Specification does not define or limit the phrase “generally collinear” (see
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Spec. 11, l. 31; Spec. 15, l. 18). Whether the Examiner‟s plot (Ans. 6) or
Appellants‟ plot (App. Br. 19) is used for comparison, the change in
diameter relative to the change in pressure is reasonably interpreted as
“generally collinear” since both lines share a positive slope with increasing
diameter as pressure increases. See, e.g., In re Hyatt, 211 F.3d 1367, 1372
(Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their
broadest reasonable interpretation consistent with the specification.”).
B. 35 U.S.C. § 103(a) over Crocker, Ryan, Alt, and Wang
The Examiner finds that “Crocker, Alt, and Ryan et al. disclose
claimed device except for the coating being selected from at least one
member of the group consisting of: poly(ethylene terephthalate) (commonly
referred to as PET), polyimide, thermoplastic polyimide, polyamides,
polyesters, polycarbonates, polyphenylene sulfides, polypropylene and rigid
polyurethanes” (Ans. 10). The Examiner finds that Wang teaches “a balloon
coating being selected from at least one member of the group consisting of:
poly(ethylene terephthalate) (commonly referred to as PET), polyimide,
thermoplastic polyimide, polyamides, polyesters, polycarbonates,
polyphenylene sulfides, polypropylene and rigid polyurethanes” (Ans. 10-
11). The Examiner finds it obvious to “provide the materials listed above
for the coating, as taught by Wang, to Crocker, Alt, and Ryan et al. in order
to restrict expansion of the balloon even after increasing the inflation
pressure” (Ans. 11).
The Examiner provides sound fact-based reasoning for combining
Wang with the earlier prior art. We adopt the fact finding and analysis of the
Examiner as our own. Appellants argue the underlying obviousness
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rejection, but Appellants do not identify any material defect in the
Examiner‟s reasoning for combining Crocker, Alt, and Ryan with Wang.
Since Appellants only argue the underlying rejection which we affirmed
above, we affirm this rejection for the reasons stated by the Examiner.
SUMMARY
In summary, we affirm the Examiner‟s rejection of claims 34, 36, and
50 under 35 U.S.C. § 103(a) as obvious over Crocker, Ryan, and Alt.
Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims
35, 37, 39, 40, and 42-47 as these claims were not argued separately
We affirm the Examiner‟s rejection of claim 48 under 35 U.S.C. §
103(a) as obvious over Crocker, Ryan, Alt, and Wang.

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

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