Ex Parte Jackson

Board of Patent Appeals and Interferences

Jun 26, 2009

11003945 (B.P.A.I. Jun. 26, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte BRAD JACKSON

Appellant
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Appeal 2009-008872
Application 11/003,945
Technology Center 3700
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Decided1: June 26, 2009
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Before JAMSON LEE, SALLY GARDNER LANE and SALLY C.
MEDLEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellant’s claims 1-12 and 23-28. Claim 29 was allowed, while claims 13-
16 were withdrawn and claims 17-22 were canceled. (App. Br. 3). We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellant claims a balloon catheter.
The Examiner relied on the following patents.
Name Number Date
Sahota 5,019,042 May 28, 1991
Vigil 5,336,234 August 9, 1994
Lemelson 5,728,123 March 17, 1998
Barath 5,797,935 August 25, 1998
The Examiner rejected claims 1 and 2 under 35 U.S.C. § 102(b) over
Lemelson. Appellant argued for the separate patentability of each of these
claims.
The Examiner also rejected claims 1-12 and 23-28 under 35 U.S.C.
§ 103(a) over either Barath or Vigil combined with Sahota. Appellant
argued for the separate patentability of claims 1, 4, 7, 9, 10, 11, 23, 24, 25,
27, and 28. We focus on these claims as representative. See 37 C.F.R.
§ 41.37(c)(1)(vii).
II. PRINCIPLES OF LAW
“Anticipation requires a showing that each limitation of a claim is
found in a single reference, either expressly or inherently.” Atofina v. Great
Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006).
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“[W]hen a patent ‘simply arranges old elements with each performing
the same function it had been known to perform’ and yields no more than
one would expect from such an arrangement, the combination is obvious.”
KSR Int’l v. Teleflex Inc., 550 US 398, 417 (2007) (quoting Sakraida v. Ag
Pro, Inc., 425 U.S. 273, 282 (1976)).
III. ANTICIPATION BY LEMELSON UNDER 35 U.S.C. § 102(B)
Issue
Does Lemelson teach a multiple balloon catheter with blades attached
to the surface of a balloon?
Findings of Fact
1. Appellant’s claim 1 recites2:

A balloon catheter comprising:
a catheter shaft having an inflation lumen extending
therethrough;
a first inflatable balloon having at least one blade
attached to its outer surface, the first inflatable balloon oriented
coaxially with the catheter shaft, an interior portion of the first
inflatable balloon being in fluid communication with the
inflation lumen; and
a second inflatable balloon.

(App. Br. 18, Claims App’x).
2. Appellant’s claim 2 recites “[t]he balloon catheter of claim 1,
wherein an interior portion of the second inflatable balloon is in fluid
communication with the inflation lumen.” (App. Br. 25, Claims App’x).

2 Claim 1 has been reformatted to include indentations between elements. 37
C.F.R. §1.75(i).
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3. Figure 1 of Appellant’s specification is reproduced below.

Figure 1 depicts a longitudinal cross-section of a multiple balloon catheter
(Spec. 3, ll. 7-8) with an inner (24) and outer (26) shaft, an inflation lumen
(30) between the inner and outer shafts, inflatable balloons (20a, 20b, 20c,
20d, and 20e), blades (60) (Spec. 3, l. 28, through 4, l. 23), and an aperture
(36) that allows for fluid communication between the lumen (30) and the
balloons (20) (id. 5, ll. 21-26).
4. Figure 1B of Lemelson is reproduced below.

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Figure 1B depicts a catheter device with a balloon (11) and cutting blades
(18). (Lemelson col. 3, ll. 40-41 and 52).
5. Figure 3 of Lemelson is reproduced below.

Figure 3 depicts a cross-section of a catheter with multiple balloons (31, 41,
and 51), tubes (30, 40, and 50) that are in fluid connection with the interior
of a balloon (31, 41, or 51, respectively), and a cutting blade (38).
(Lemelson col. 4, ll. 50-59).
6. Lemelson teaches that blade (38) may be directly cemented to
the walls of the balloon. (Lemelson col. 5, ll. 35-36).

Analysis
Appellant claims a balloon catheter with a shaft that has a lumen, a
first balloon with a blade attached to the outer surface where the interior of
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the first balloon is in fluid communication with the lumen of the shaft, and a
second balloon. (FF3 1).
Lemelson teaches a balloon catheter (FFs 4 and 5) with a tube or
shaft, a cutting blade, and multiple balloons in fluid communication with the
lumens of the shafts. (FF 5). Lemelson also teaches that the cutting blade
may be directly cemented onto the wall of the balloon. (FF 6). Thus,
contrary to Appellant’s argument (App. Br. 6-8), even though Lemelson
does not depict in a figure a blade cemented to a balloon, the Lemelson
specification provides an alternative embodiment with this feature. (FF 6).
Because Lemelson teaches each limitation recited in claim 1, it anticipates
the claimed balloon catheter. See Atofina, 441 F.3d at 999.
Appellant argues separately for the patentability of claim 2. Claim 2
requires that the second balloon be in communication with the inflation
lumen cited in claim 1. (FF 2). Claim 1 recites “an inflation lumen” (FF 1
(emphasis added)), but Appellant’s specification provides for embodiments
with multiple inflation lumens that communicate separately with individual
balloons. (See Spec. 6, l. 20, through 7, l. 3; Figures 5 and 6). The Federal
Circuit
has repeatedly emphasized that an indefinite article “a” or “an”
in patent parlance carries the meaning of “one or more” in
open-ended claims containing the transitional phrase
“comprising.” . . . Unless the claim is specific as to the number
of elements, the article “a” receives a singular interpretation
only in rare circumstances when the patentee evinces a clear
intent to so limit the article.

3 Finding of fact.
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KCJ Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351, 1356 (Fed. Cir. 2000).
Because we find no claim language that demonstrates intent to limit the
claimed balloon catheter to one lumen, Appellant’s claim 2 encompasses a
balloon catheter with more than one inflation lumen. Furthermore, the
second inflatable balloon of the claimed catheter can be in fluid
communication with a different inflation lumen from the first balloon. We
do not agree with Appellant that “claim 2 requires the first and second
balloons to be in fluid communication with the same inflation lumen.”
(App. Br. 9 (emphasis in original)). Had Appellant wished to limit claim 2
in such a manner he could have done so.
Lemelson provides an embodiment of a balloon catheter that has
multiple balloons, but each is in fluid communication with a separate
inflation lumen. (FF 5; balloons 31, 41, and 51, in communication with
tubes 30, 40, and 50, respectively and independently). Thus, the Examiner
did not err in rejecting claim 2 over Lemelson.

IV. OBVIOUSNESS OVER EITHER BARATH OR VIGIL AND
SAHOTA UNDER 35 U.S.C. § 103(A)
Issue
Would those of skill in the art have had reason to add cutting blades to
a multiballoon catheter to allow for incising of stenoses that require
navigation of tortuous curves?
Findings of Fact
7. Barath relates to devices that are used with an angioplasty
balloon for incising a stenosis, or narrowing of a blood vessel, with blades
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mounted on an angioplasty balloon. (Barath col. 1, ll. 10-12; col. 2, ll. 26-
29).
8. Figure 3 of Barath is reproduced below.

Figure 3 depicts a device mounted on an angioplasty balloon, which includes
angioplasty balloon (34) and the cutting blade (12) of the device (10).
(Barath col. 4, ll. 21-26).
9. Vigil relates to devices for incision of stenoses that have cutting
blades mounted on the outer surface of a collapsible balloon. (Barath col. 1,
ll. 10-19).
10. Figure 1 of Vigil is reproduced below.
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Figure 1 depicts a device taught by Vigil, including atherotomes (19)
mounted on an angioplasty balloon (12). (Vigil col. 3, ll. 30 and 61-62).
11. Sahota relates to balloon catheters.
12. Figure 7 of Sahota is reproduced below.

Figure 7 depicts a cross-section of a multi-lobed dilation balloon (32)
positioned within a patient’s artery (Sahota col. 3, ll. 61-63; col. 5),
including multiple balloons (36) in fluid communication with a curved
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catheter shaft (14) so that it can negotiate tortuous vessels (id. col. 6, ll. 24-
40).
Analysis
Independent Claim 1
Those of skill in the art would have attached cutting blades, as taught
in either Barath (FF 8) or Vigil (FF 10), to a multi-lobed angioplasty
balloon, as taught in Sahota (FF 12) to allow for incising stenoses (FFs 7 and
9) that are accessible through tortuous vessels. Because Appellant’s claimed
device arranges these known elements, with each performing the function
taught in the art, the combination is obvious. See KSR, 441 F.3d at 999.
Appellant argues that the Examiner did not clarify how the devices of
Barath or Vigil would be modified to achieve the claimed device.
According to Appellant, the Examiner’s rejection requires either dividing the
balloon in Barath or Vigil to make multiple balloons or adding extra
balloons to the ends. (App. Br. 11). Appellant argues that each of these
options is unsuitable because:
• the blades of Barath and Vigil would not be able to negotiate
tortuous curves if they extend along the entire length of the
multi-lobed balloon as in Barath and Vigil (App. Br. 13);
• Barath requires a “setback distance” of twice the radius of the
balloon (Appellant cites to Barath at col. 3, ll. 50-59), which
would be impossible on the spherical balloons of Sahota (App.
Br. 13-14); and
• the balloons of Barath or Vigil would be too long to negotiate a
tortuous curve as depicted in Figure 7 of Sahota even if they
were multiplied (App. Br. 15).
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We do not find these arguments persuasive. Appellant is taking a
narrow view of the cited prior art. “One of the ways in which [claimed]
subject matter can be proved obvious is by noting that there existed at the
time of invention a known problem for which there was an obvious solution
encompassed by the … claims.” KSR, 550 US at 419-20. Barath and Vigil
teach that blades can be mounted on catheter balloons to incise stenoses.
Sahota teaches that multiple balloons allow for negotiation of tortuous
curves. Appellant claims an inflatable balloon catheter with a blade attached
to at least one of multiple balloons. (FF 1). Whether the balloons of Barath
or Vigil are divided or added, it would still have been within the skill of any
artisan to figure out how to mount a blade on a balloon so that it would be
able to maneuver through tortuous curves, once these elements were learned
from the art.
In fact, Appellant states that “[i]f a person of ordinary skill in the art
desired to dilate a sharp bend, they would simply use the Sahota multi-lobed
balloon, rather than attempting to modify Barath/Vigil and use blades in a
highly curved vessel.” (App. Br. 16). We agree that such a combination
also would have rendered obvious the claimed subject matter. See In re
Cowles, 156 F.2d 551, 554 (CCPA 1946) (holding that handling references
cited by the Examiner in a different manner than the Examiner does not
constitute a new grounds of rejection, if the claimed subject matter involves
nothing inventive over the prior art). Thus, Appellant has not persuaded us
that the combination of Barath or Vigil and Saharto fails to teach the claimed
balloon catheter is not obvious.

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Appellant argued separately for the patentability of the following
dependent claims.
Dependent Claims 4 and 7
13. Appellant’s claim 4 recites: “The balloon catheter of claim 1,
further comprising a third inflatable balloon.” (App. Br. 25, Claims App’x).
14. Appellant’s claim 7 recites: “The balloon catheter of claim 4,
further comprising a fourth inflation balloon in fluid communication with
the inflation lumen, the fourth inflation balloon comprising at least one
blade.” (App. Br. 25, Claims App’x).

Figure 7 of Sahota teaches an inflatable catheter with four balloons.
(FF 11). Though Appellant argues that the Examiner did not present a prima
facie case for the obviousness of the balloon catheter recited in claims 4 and
7, no argument or evidence was presented that it would not have been
obvious to those of skill in the art to make a balloon catheter as claimed,
with three or four balloons. Accordingly, Appellant has not persuaded us
that the claimed balloon catheters are not obvious.

Dependent Claims 9, 10, and 11
15. Appellant’s claim 9 recites: “The balloon catheter of claim 1,
the catheter shaft comprising an inner shaft and an outer shaft, the inflation
lumen located between the inner shaft and the outer shaft.” (App. Br. 25,
Claims App’x).
16. Appellant’s claim 10 recites: “The balloon catheter of claim 9,
wherein a distal end of the first inflatable balloon is attached to said inner
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shaft, and a proximal end of the first inflatable balloon is attached to said
outer shaft.” (App. Br. 26, Claims App’x).
17. Appellant’s claim 11 recites: “The balloon catheter of claim 10,
wherein a distal end of the second inflatable balloon is attached to said outer
shaft, and a proximal end of the second inflatable balloon is attached to said
outer shaft.” (App. Br. 26, Claims App’x).
18. Figure 5 of Sahota is reproduced below.

Figure 5 depicts a balloon catheter with multiple shafts, including separate
inflation lumens (44), which are each connected to separate lobes of the
multi-lobed balloon. (Sahota col. 6, ll. 46-49).

Sahota teaches balloon catheters with multiple shafts. Appellant
argues that Sahota does not teach an inflation lumen that is defined by the
individual shafts (44) and so does not render the catheter recited in claim 9
obvious. “When a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the
same field or a different one. If a person of ordinary skill can implement a
predictable variation, § 103 likely bars its patentability.” KSR, 550 US at
417. We agree that it would have been an obvious variation for one of skill
in the art to have constructed a balloon catheter with an inner shaft and an
outer shaft, as recited in Appellant’s claim 9, or with the arrangements of
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balloons attached to the shafts, as recited in Appellant’s claims 10 and 11,
once a balloon catheter with multiple shafts was known from Sahota.
Appellant has not provided evidence that the claimed modifications produce
novel or unexpected results or that they are not within the skill in the art.
Thus, we are not persuaded that the catheter recited in claim 9 is not
obvious. Similarly, we are not persuaded that the arrangement of the
balloons recited in claims 10 and 11 are not obvious.

Independent Claim 23
19. Appellant’s claim 23 recites:
A balloon catheter comprising:
a catheter shaft having a longitudinal axis;
a first inflatable balloon comprising a first blade; and
a second inflatable balloon comprising a second blade,
the second inflatable balloon located proximal to the first
inflatable balloon along the length of the catheter shaft;
the first blade separated from the second blade by a first
distance as measured in a direction parallel to the longitudinal
axis, the first distance being less than a length of the first blade.

(App. Br. 26, Claims App’x).

Appellant’s claim 23 recites a balloon catheter with a specific distance
between the blades attached to the balloons. (FF 19). Appellant argues that
the distance is “critical to the device’s ability to fully dilate a long lesion
with a single reinflation step . . .” (App. Br. 19) and cite to the specification
at page 5, lines 27-31. This portion of the specification discusses the general
desirability of choosing sizes that allow for treatment with only one
repositioning and re-inflation, but does not discuss the distance between the
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blades that is specifically claimed. As we noted above, if one having
ordinary skill in the art was able to make a variation of a known device and
the variation only led to a predictable result, then § 103 likely bars
patentability of this variation. KSR, 550 US at 417. Appellant has not
directed us to evidence showing that any unexpected result was achieved by
the variation. Thus, we are not persuaded by Appellant’s argument about the
criticality of the distance.

Dependent claims 24 and 25
20. Appellant’s claim 24 recites: “The balloon catheter of claim 23,
further comprising a third inflatable balloon comprising a third blade; the
second blade separated from the third blade by a second distance as
measured in a direction parallel to the longitudinal axis, the second distance
being less than a length of the second blade.” (App. Br. 26, Claims App’x).
21. Appellant’s claim 25 recites: “The balloon catheter of claim 24,
wherein the first distance is equal to the second distance.” (App. Br. 26,
Claims App’x).

Appellant argues for the separate patentability of claims 24 and 25,
but did not provide evidence that the distances recited in these claims
produce unexpectedly good results. We are not persuaded by Appellant’s
arguments. See KSR, 550 US at 417.

Dependent claims 27 and 28
22. Appellant’s claim 27 recites: “The balloon catheter of claim 26,
the catheter shaft comprising an inner shaft and an outer shaft, the inflation
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lumen located between the inner shaft and the outer shaft.” (App. Br. 27,
Claims App’x)
23. Appellant’s claim 28 recites: “The balloon catheter of claim 27,
wherein a distal end of the first inflatable balloon is attached to said inner
shaft, and a proximal end of the first inflatable balloon is attached to said
outer shaft.” (App. Br. 27, Claims App’x).

Appellant argued for the separate patentability of claims 27 and 28,
but referred only to the arguments made against the rejection of claims 9 and
10, which were discussed above. For the reasons provided above, Appellant
has not persuaded us that the devices recited in claims 27 and 28 are
nonobvious.
V. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 1 and 2 under 35 U.S.C. § 102 (b) over
Lemelson is AFFIRMED; and
the rejection of claims 1-12 and 23-28 under 35 U.S.C. § 103(a) over
either Barath or Vigil combined with Sahota is AFFIRMED.
FURTHER ORDERED that 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

ack

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