Ex Parte Gesswein

Board of Patent Appeals and Interferences

Jun 2, 2010

10394630 (B.P.A.I. Jun. 2, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DOUGLAS GESSWEIN
____________

Appeal 2009-006682
Application 10/394,630
Technology Center 3700
____________

Decided: June 2, 2010
____________

Before LINDA E. HORNER, STEFAN STAICOVICI and
KEN B. BARRETT, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2009-006682
Application 10/394,630

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STATEMENT OF THE CASE
Douglas Gesswein (Appellant) appeals under 35 U.S.C. § 134 (2006)
from the Examiner’s decision rejecting claims 1-20. We have jurisdiction
over this appeal under 35 U.S.C. § 6 (2006).

THE INVENTION
Appellant’s invention relates to a guiding catheter 100 including an
open lumen 204, an inner liner 202, one or more steering lumens 208, one or
more inflation lumens 212, an intermediate sheath 210, and an outer sheath
206. Spec. 6, ll. 3-15 and fig. 2. By pressurizing and depressurizing fluid
within steering lumens 208, via inflation lumens 212, the catheter 100 is
steered within blood vessels. Spec. 6, ll. 16-24.
Claim 1 is representative of the claimed invention and reads as
follows:
1. A guiding catheter for accessing a patient's heart,
comprising:

a flexible shaft having an open lumen and a pre-shaped distal
portion;

one or more inflatable steering lumens disposed within a wall
of the flexible shaft proximate the pre-shaped distal portion;
and

one or more inflation lumen portions of the steering lumens in
fluid connection with the steering lumens, the inflation lumen
portions accessible at a proximal end of the shaft, wherein
changing a fluid pressure of the steering lumens alters a shape
of the pre-shaped distal end of the flexible shaft.

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Application 10/394,630

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THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Del Guercio US 3,665,928 May 30, 1972
Maloney US 4,906,230 Mar. 6, 1990
Loiterman US 4,983,165 Jan. 8, 1991
Sogawa US 5,308,323 May 3, 1994

The following rejections are before us for review:
The Examiner rejected claims 1-20 under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
The Examiner rejected claims 1, 2, 7, 9-12, 15, 18, and 19 under 35
U.S.C. § 102(b) as anticipated by Del Guercio.
The Examiner rejected claims 1, 2, 9, 10, 12, and 15 under 35 U.S.C.
§ 102(b) as anticipated by Maloney.
The Examiner rejected claims 12-14 under 35 U.S.C. § 102(b) as
anticipated by Loiterman.
The Examiner rejected claims 12-20 under 35 U.S.C. § 102(b) as
anticipated by Sogawa.

THE ISSUES
1. Do the limitations “inflatable steering lumens” in claims 1-11 and 15-
20 and “means for inflatably steering” in claims 12-14 render claims
1-20 indefinite under 35 U.S.C. § 112, second paragraph?
2. Does each of Del Guercio, Maloney, and Loiterman teach a catheter
having “inflatable steering lumens”?
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3. Does Sogawa teach a catheter having “inflatable steering lumens”
located within a wall of the catheter shaft?
SUMMARY OF DECISION
We REVERSE.
OPINION
Issue (1)
The indefiniteness rejection
Each of independent claims 1, 9, and 15 includes the limitation “one
or more inflatable steering lumens.” With respect to independent claim 12,
while it does not explicitly recite “one or more inflatable steering lumens,” it
does recite “means for inflatably steering the distal end of the flexible shaft
disposed within a wall of the flexible shaft.”1 According to the Examiner, a
lumen cannot be inflatable. Final Rejection, mailed Mar. 21, 2006, at 3.
Rather, the Examiner takes the position that the material surrounding the
lumen is inflatable. Ans. 3-4. In response, Appellant argues that “the term
‘inflatable lumen’ is an acceptable way of describing a lumen that may
expand or contract.” App. Br. 8.
It is well established that the test for definiteness under 35 U.S.C. §
112, second paragraph, is whether "those skilled in the art would understand
what is claimed when the claim is read in light of the specification."
Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed.
Cir. 1986) (citations omitted). In this case, although we agree with the
Examiner that in an inflatable lumen it is the material surrounding the lumen
that expands, nonetheless, when the material expands the lumen also

1 Appellant’s Specification describes such “means for inflatably
steering” as being inflatable steering lumens 208. Spec. 6, ll. 16-18; App.
Br. 6
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expands. For example, as Appellant argues, when blowing air into a balloon
the walls of the balloon expand as the interior space of the balloon also
expands. See Reply Br. 8. As such, we agree with Appellant that the term
“inflatable lumen” would be understood in the art to mean a lumen that
expands or contracts. See App. Br. 8. Accordingly, we conclude that claims
1-20 are not indefinite under 35 U.S.C. § 112, second paragraph. Therefore,
the rejection of claims 1-20 under 35 U.S.C. § 112, second paragraph, as
being indefinite cannot be sustained.
Issue (2)
The anticipation rejection over Del Guercio
Appellant argues that Del Guercio does not teach a catheter having
one or more “inflatable steering lumens.” App. Br. 9. In response, the
Examiner takes the position that because the collar 32 and the grips 30 of
Del Guercio are made from rubber, the walls surrounding the channels 36,
38 and/or 44, 46 are also made of rubber, and as such are inflatable. Ans. 5.
The Examiner appears to interpret the channels 36, 38 and/or 44, 46 of Del
Guercio as the claimed “inflatable steering lumens.”
We disagree with the Examiner’s position for the following reasons.
First, we find that an ordinary and customary meaning of the term “inflate”
is “to swell or distend with air or gas.” MERRIAM WEBSTER’S COLLEGIATE
DICTIONARY (10th Ed. 1997). In other words, we find that an “inflatable
steering lumen” is a steering lumen that can swell or distend, that is, can
expand when pressurized with a gas. Second, we note that the Examiner
appears to rely on a theory of inherency to show that Del Guercio teaches
that the walls surrounding the channels 36, 38 and/or 44, 46 are made of
rubber, and as such are inflatable. “Inherent anticipation requires that the
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missing descriptive material is ‘necessarily present,’ not merely probably or
possibly present, in the prior art.” Trintec Indus., Inc. v. Top-U.S.A. Corp.,
295 F.3d 1292, 1295 (Fed. Cir. 2002) (quoting In re Robertson, 169 F.3d
743, 745 (Fed. Cir. 1999)). In this case, the question raised is whether the
walls surrounding the channels 36, 38 and/or 44, 46 of Del Guercio are
necessarily inflatable.
It is our finding that when a fluid is forced through constriction 42 of
Del Guercio’s catheter, a jet stream is formed which forces the fluid to
attach to one of walls 70 and 72. For example, when the fluid attaches to
wall 70 the fluid flows through channel 36 and impinges upon tip member
16 upon exiting at opening 56. The passage of the fluid through the opening
56 shifts the tip member to the right as shown in Figure 3 and increases the
pressure at opening 50 of channel 44 to deflect the fluid to the opposite wall
72. Thus, the fluid is directed into channel 38 and impinges upon tip
member 36 upon exiting at opening 62 to move the tip member 16 to the left
in a direction opposite that shown in Figure 3 and to increase the pressure at
opening 48 of channel 46. Continued passage of fluid through channels 36,
38 causes automatic oscillation of the tip member 16 until the member 16
reaches an impenetrable obstacle or until the forcing of fluid is discontinued.
Del Guercio, col. 4, l. 44 though col. 5, l. 12 and fig. 3.
Hence, it is our finding that the oscillation of tip member 16 is the
result of fluid pressure balances at openings 48, 50, 52, and 56. If the walls
surrounding the channels 36, 38 and/or 44, 46 were inflatable, as the
Examiner opines, the expansion of the walls would modify the cross-section
of the channels 36, 38 and/or 44, 46 and as such would modify the fluid
pressure balances at openings 48, 50, 52, and 56. Hence, a change in the
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fluid pressure balances at openings 48, 50, 52, and 56 would affect the
lateral oscillatory motion of tip member 16. Therefore, we conclude that the
walls surrounding the channels 36, 38, and/or 44, 46 are not necessarily
inflatable. The Examiner has not provided sufficient evidence to support the
finding that channels 36, 38 and/or 44, 46 of Del Guercio constitute
“inflatable steering lumens,” as called for by each of independent claims 1,
9, 12, and 15.
Inasmuch as we found that Del Guercio does not teach “inflatable
steering lumens,” Del Guercio does not teach all the elements of
independent claims 1, 9, 12, and 15 or their respective, rejected dependent
claims. Accordingly, the rejection of claims 1, 2, 7, 9-12, 15, 18, and 19
under 35 U.S.C. § 102(b) as anticipated by Del Guercio cannot be sustained.

The anticipation rejection over Maloney
Appellant argues that Maloney does not teach a catheter having one or
more “inflatable steering lumens.” App. Br. 11. In response, the Examiner
takes the position that “if the steering lumens [22, 24] within the walls were
not inflatable, then the bellows [20] would not be able to expand.” Ans. 6.
The Examiner appears to interpret the inflation lumen 24 and the fluid
passage 22 of Maloney as the claimed “inflatable steering lumens.”
Since the Examiner has not specifically pointed to any portion of
Maloney to show that the inflation lumen 24 and the fluid passage 22 are
inflatable, the Examiner appears to rely on a theory of inherency to make
such a showing. It is our finding that the bellows folds 20 of Maloney are in
fluid communication with the inflation lumen 24 through the fluid passage
22. Maloney, col. 4, ll. 13-17 and fig. 2. Furthermore, Maloney specifically
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teaches that the passage of pressurized gas from the inflation lumen 24
through the fluid passage 22 places the bellows folds 20 in longitudinal
tension so as to cause distal portion 18 of catheter 12 to deflect in a
controlled manner and hence allow catheter 12 to follow a tortuous path
within a patient’s body. Maloney, col. 4, l. 57 through col. 5, l. 10 and figs.
1, 2, and 4.
Hence, if the walls surrounding the inflation lumen 24 and the fluid
passage 22 were inflatable, as the Examiner opines, the expansion of the
walls would modify the pressure of the gas impinging on bellows 20 and
hence would affect the amount of deflection of the distal portion 18 of
Maloney’s catheter 12. In conclusion, the walls surrounding the inflation
lumen 24 and the fluid passage 22 are not necessarily inflatable. Therefore,
the Examiner has not provided sufficient evidence to support the finding that
inflation lumen 24 and fluid passage 22 of Maloney constitute “inflatable
steering lumens,” as called for by each of independent claims 1, 9, 12, and
15.
Inasmuch as we found that Maloney does not teach “inflatable
steering lumens,” Maloney does not teach all the elements of independent
claims 1, 9, 12, and 15 or their respective, rejected dependent claims.
Accordingly, the rejection of claims 1, 2, 9, 10, 12, and 15 under 35 U.S.C. §
102(b) as anticipated by Maloney likewise cannot be sustained.

The anticipation rejection over Loiterman
Appellant argues that Loiterman does not teach “means for inflatably
steering the distal end of the flexible shaft.” App. Br. 13. In response, the
Examiner takes the position that “element 7 would be capable of being
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inflated.” Ans. 7. The Examiner appears to interpret the ducts 7 of
Loiterman as the claimed “means for inflatably steering the distal end of the
flexible shaft.”
Since the Examiner has not specifically pointed to any portion of
Loiterman to show that ducts 7 are inflatable, it appears that the Examiner is
once more relying on a theory of inherency to make such a showing.
Loiterman teaches a catheter having a tubular member 1, a distal set of
balloons 4, a proximal set of balloons 5, and ducts 7 connected to each
balloon 4, 5 for providing a pressurized fluid to balloons 4, 5. Loiterman,
col. 3, ll. 29-30 and 48-50; col. 4, ll. 7-18; and figs. 1 and 3. Loiterman
further teaches that selective inflation of balloons 4, 5 causes catheter tip
deflection. Loiterman, col. 4, ll. 24-31. As such, if the walls surrounding
the ducts 7 were inflatable, as the Examiner opines, the expansion of the
walls would modify the pressure of the gas inflating the balloons 4, 5 and
hence would affect the amount of catheter tip deflection. Hence, the walls
surrounding the ducts 7 are not necessarily inflatable. Therefore, the
Examiner has not provided sufficient evidence to support the finding that the
ducts 7 of Loiterman constitute “means for inflatably steering the distal end
of the flexible shaft,” as called for independent claim 12.
Inasmuch as we found that Loiterman does not teach, “means for
inflatably steering the distal end of the flexible shaft,” Loiterman does not
teach all the elements of independent claim 12. Accordingly, the rejection
of claims 12-14 under 35 U.S.C. § 102(b) as anticipated by Loiterman
cannot be sustained.

Issue (3)
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Application 10/394,630

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The anticipation rejection over Sogawa
Appellant argues that Sogawa fails to teach “means for inflatably
steering the distal end of the flexible shaft disposed within a wall of the
flexible shaft,” as per claim 12 and “one or more inflatable steering lumens
disposed between the inner lining and the outer sheath at a distal portion of
the flexible shaft,” as per claim 15. App. Br. 14. According to Appellant,
the inflatable compartments 4 of Sogawa are located on the exterior surface
of the catheter tube. Id. The Examiner responds that the inflatable steering
lumen 4 of Sogawa (inflatable compartment 4) is located within the interior
of outer wall 2, specifically between outer wall 2 and the inner lining 6.
Ans. 7.
It is our finding that Sogawa teaches a front tip of a catheter including
a balloon 2 having a plurality of inflatable compartments 4 (inflatable
steering lumens) separated by walls 3. Sogawa, col. 2, ll. 33-38 and figs. 1
and 2. Sogawa further teaches a channel 5 for supplying a pressurized gas to
each inflatable compartment 4 via openings 9 in the wall of tube 6. Sogawa,
col. 2, ll. 38-43 and fig. 2. Furthermore, Sogawa teaches a channel 7 located
within inside tube 6 for supplying drugs. Sogawa, col. 2, ll. 47-49 and fig. 2.
Since pressurized gas and drugs are supplied through channels 5 and 7,
respectively, a person of ordinary skill in the art would have readily
recognized that the tube 6 of Sogawa constitutes the shaft of catheter 1,
whereas the inflatable compartments 4 are part of balloon 2. Accordingly,
we agree with Appellant that inflatable compartments 4 of Sogawa are
located on the exterior surface of the catheter tube, that is, on the exterior of
the tube 6. See App. Br. 14. Hence, Sogawa fails to teach inflatable steering
lumens located within a wall of the catheter shaft.
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Inasmuch as we found that Sogawa does not teach inflatable steering
lumens located within a wall of the catheter shaft, Sogawa does not teach all
the elements of independent claims 12 and 15 or their respective, rejected
dependent claims. Accordingly, the rejection of claims 12-20 under 35
U.S.C. § 102(b) as anticipated by Sogawa cannot be sustained.

CONCLUSIONS
1. The limitations “inflatable steering lumens” in claims 1-11 and 15-20
and “means for inflatably steering” in claims 12-14 do not render
claims 1-20 indefinite under 35 U.S.C. § 112, second paragraph.
2. Neither of Del Guercio, Maloney, nor Loiterman teaches a catheter
having “inflatable steering lumens.”
3. Sogawa fails to teach a catheter having “inflatable steering lumens”
located within a wall of the catheter shaft.

DECISION
The Examiner’s decision to reject claims 1-20 is reversed.

REVERSED

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