Ex Parte Cunningham

Board of Patent Appeals and Interferences

Jun 16, 2009

10264567 (B.P.A.I. Jun. 16, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JON CUNNINGHAM
__________

Appeal 2009-000693
Application 10/264,567
Technology Center 3700
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Decided:1June 16, 2009
__________

Before ERIC GRIMES, LORA M. GREEN, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
catheter. The Examiner has rejected the claims as anticipated or obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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).
Appeal 2009-000693
Application 10/264,567

STATEMENT OF THE CASE
Claims 1, 6-15, 17-21, 27, and 29-39 are pending and on appeal (App.
Br. 2). We will focus on claims 1 and 14, which read as follows:
1. A catheter comprising:
a) at least two lumens configured to extend from a proximal
end of the catheter to a distal end of the catheter;
b) an expandable chamber; and
c) a means for expanding the expandable chamber,
wherein the expandable chamber is attached to the catheter at a
position that is in a subcutaneous tunnel when the catheter is in a
medically appropriate working position, the expandable chamber is in
fluid connection with the means for expanding the expandable
chamber, and the expandable chamber is expandable from a
contracted state to an expanded state,
whereby the expansion of the expandable chamber from the
contracted state to the expanded state causes the application of
pressure to the subcutaneous tunnel for stabilizing the catheter within
the subcutaneous tunnel.
14. A hemodialysis catheter, comprising:
a) at least two lumens extending from a proximal end of the
catheter to a distal end of the catheter and configured to
extend through a subcutaneous tunnel;
b) an expandable chamber positioned on the hemodialysis
catheter such that the expandable chamber is positioned
within the subcutaneous tunnel, and the expandable
chamber having a variable expansion state;
c) a means for expanding the expandable chamber upon the
introduction of a biocompatible filler thereinto, the
means for expanding the expandable chamber comprising
an inflation port in fluid communication with the
expandable chamber,
wherein when the biocompatible filler is introduced into the
inflation port and consequently into the expandable chamber, the
expandable chamber expands from a contracted state to an expanded
state;
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whereby the expansion of the expandable chamber applies
pressure to the subcutaneous tunnel and the pressure applied by the
expandable chamber to the subcutaneous tunnel improves the stability
of the hemodialysis catheter in position within the subcutaneous
tunnel.
Claims 1, 6, 8-10, 13-15, 17, 21, 27, 29, 33, 37, and 38 stand rejected
under 35 U.S.C. § 102(b) as anticipated by Jacobs (US 3,788,326, Jan. 29,
1974) (Ans. 3).
Claims 1, 6, 8-10, 13-15, 17, 21, 27, 29, and 33-38 stand rejected
under 35 U.S.C. § 102(b) as anticipated by Booth (US 5,653,690, Aug. 5,
1997) (Ans. 4).
Claims 7, 11, 12, 18-20, 30-32, and 39 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Booth in view of Evans (US 6,645,234 B2,
Nov. 11, 2003) (Ans. 6).
PRINCIPLES OF LAW
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987). “An intended use or purpose usually will
not limit the scope of the claim because such statements usually do no more
than define a context in which the invention operates.” Boehringer
Ingelheim Vetmedica v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed.
Cir. 2003). “A claimed invention cannot be anticipated by a prior art
reference if the allegedly anticipatory disclosures cited as prior art are not
enabled.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313,
1354 (Fed. Cir. 2003).
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Appeal 2009-000693
Application 10/264,567

CLAIM INTERPRETATION
Claim 1 is directed to a catheter comprising an expandable chamber
attached to the catheter at a position that is in a subcutaneous tunnel when
the catheter is in a medically appropriate working position. We interpret this
language to require that the catheter have an expandable chamber at a
position that could be in a subcutaneous tunnel when the catheter is in a
medically appropriate working position.
Claim 14 is directed to a hemodialysis catheter. We interpret this
language to require a catheter that could be used for hemodialysis.
JACOBS
The Examiner rejects claim 1, 6, 8-10, 13-15, 17, 21, 27, 29, 33, 37,
and 38 as anticipated by Jacobs (Ans. 3).
Appellant argues that Jacobs does not disclose: (a) at least two
lumens that extend from the proximal end to the distal end of the catheter
(App. Br. 8-9); (b) an expandable chamber attached to the catheter at a
position that is in a subcutaneous tunnel when the catheter is in a medically
appropriate working position (id. at 9); and, with regard to claim 14, (c) a
hemodialysis catheter (id. at 11).
Issues
Has Appellant shown that the Examiner erred in finding that Jacobs
discloses a catheter comprising at least two lumens that extend from a
proximal end to a distal end of the catheter?
Has Appellant shown that the Examiner erred in finding that Jacobs
discloses a catheter having an expandable chamber attached to the catheter at
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a position that could be placed in a subcutaneous tunnel when the catheter is
in a medically appropriate working position?
Has Appellant shown that the Examiner erred in finding that Jacobs
discloses a catheter that could be used for hemodialysis?
Findings of Fact
1. Jacobs discloses a tracheal catheter (Jacobs, Abstract).
2. Jacobs Figure 10B is reproduced below:

Jacobs Figure 10B depicts a straight catheter having a premolded
balloon 274 (id. at col. 3, ll. 50-52, & col. 6, ll. 34-35).
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Application 10/264,567

3. The catheter depicted in Figure 10B has three lumens, 267, 268,
and 269, with lumens 268 and 269 extending to the distal end of the catheter
(id. at col. 6, ll. 30-32, & Fig. 10B).
Analysis
Appellant argues that Jacobs discloses a “single catheter/lumen that
extends from the proximal end to the distal end, but a triple catheter (in the
form of an adaptor) at the proximal end” (App. Br. 8-9). We are not
persuaded. Instead, we agree with the Examiner that Jacobs discloses that
lumens 268 and 269 extend to the distal end of the catheter (Findings of Fact
(FF) 2-3; Ans. 3).
In addition, Appellant argues that Jacobs discloses an “elastic balloon
that inflates and is within the patient and not within the subcutaneous
channel. This elastic balloon is positioned on the catheter such that the
balloon will be in the trachea when the catheter is placed in a patient.”
(App. Br. 9.) Appellant also argues:
Jacobs . . . discloses a catheter in which the expandable
chamber cannot be in the subcutaneous tissues, as such an
action would render the catheter unusable. Contrary to the
examiner’s position, Jacobs . . . is a tracheal catheter . . . , which
dictates that the structure of the catheter have the expandable
chamber in a position that allows the decrease of the tracheal
opening, i.e. in the trachea.
(Id. at 10.)
We are not persuaded. Jacobs discloses a catheter having an
expandable chamber, i.e., the balloon (FF 2). We agree that Jacobs discloses
a tracheal catheter (FF 1). However, Appellant has not shown that Jacob’s
catheter could not be inserted in a medically appropriate working position
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with the balloon in a subcutaneous tunnel. This position may not be
medically appropriate for a tracheotomy. However, Appellant has not
shown that this position would not be medically appropriate for any purpose,
such as hemodialysis.
Appellant also argues that Jacobs fails to enable the claimed invention
(App. Br. 12). In particular, Appellant argues:
[T]he examiner has failed to include any substantive guide as to
how one could create a catheter with the expandable chamber
located in the subcutaneous tunnel from . . . a tracheal catheter.
. . . Specifically, the examiner has failed to identify why anyone
would . . . move the expandable chamber of a tracheal catheter
from the tracheal position to the subcutaneous tissue.
(Id.)
However, claims 1 and 14 are both directed to a product. They do not
require that the expandable chamber be in a subcutaneous tunnel; instead
they require that the expandable chamber could be in a subcutaneous tunnel.
Thus, to anticipate these claims, Jacobs need not teach or enable placing the
expandable chamber in a subcutaneous tunnel.
With regard to claim 14, Appellant additionally argues that “a
hemodialysis catheter is not a tracheal catheter . . . . and is structured
differently [there]from” (App. Br. 11). However, Appellant has not pointed
to any specific structural difference between Jacob’s catheter and a catheter
that could be used for hemodialysis. Therefore, we are not persuaded by this
argument.
Conclusion
Appellant has not shown that the Examiner erred in finding that
Jacobs discloses a catheter comprising at least two lumens that extend from
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a proximal end to a distal end of the catheter; a catheter having an
expandable chamber attached to the catheter at a position that could be
placed in a subcutaneous tunnel when the catheter is in a medically
appropriate working position; and/or a catheter that could be used for
hemodialysis. We therefore affirm the anticipation rejection of claims 1 and
14 over Jacobs. Claims 6, 8-10, 13, 15, 17, 21, 27, 29, 33, 37, and 38 have
not been argued separately and therefore fall with claims 1 and 14. 37
C.F.R. § 41.37(c)(1)(vii).
BOOTH
The Examiner rejects claims 1, 6, 8-10, 13-15, 17, 21, 27, 29, and 33-
38 as anticipated by Booth (Ans. 4). The Examiner also rejects claims 7, 11,
12, 18-20, 30-32, and 39 as obvious over Booth in view of Evans (id. at 6).
Appellant argues that Booth does not disclose: (a) an expandable
chamber attached to the catheter at a position that is in a subcutaneous tunnel
when the catheter is in a medically appropriate working position (App.
Br. 9); and, with regard to claim 14, (b) a hemodialysis catheter (id. at 11).
Issues
Has Appellant shown that the Examiner erred in finding that Booth
discloses a catheter having an expandable chamber attached to the catheter at
a position that could be placed in a subcutaneous tunnel when the catheter is
in a medically appropriate working position?
Has Appellant shown that the Examiner erred in finding that Booth
discloses a catheter that could be used for hemodialysis?
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Findings of Fact
4. Booth discloses a “catheter for retrograde perfusion of the heart
through the coronary sinus, which has an infusion lumen for introducing
perfusion liquid into the heart [and] a retention means such as an inflatable
balloon” (Booth, Abstract).
5. In addition, Booth discloses that the catheter also includes a
pressure monitoring lumen 36 (id. at col. 5, ll. 36-37).
Analysis
Appellant argues that Booth discloses an “expandable chamber, which
is not in the subcutaneous channel. This expandable chamber is positioned
on the catheter such that the balloon will be in a heart vessel.” (App. Br. 9.)
In addition, Appellant argues:
Booth . . . discloses an expandable chamber that cannot rest in
the subcutaneous tunnel. While Booth . . . does disclose a
catheter with a balloon retention enhancement, the balloon
enhancement is only for providing an effective seal on the
coronary sinus. . . . If Applicant’s device is combined with the
Booth . . . catheter, it would be placed at the cuff or suture
ring 28. A balloon placed at this position cannot be inherent in
Booth . . . because Booth . . . does not disclose using a balloon
in place of a suture ring 28, which was not known in the art and
hence not present in the reference.
(Id. at 10.)
We are not persuaded. Booth discloses a catheter having an
expandable chamber, i.e., the balloon (FF 4). The Examiner does not
contend that Booth teaches or suggests placing a balloon at the cuff or suture
ring 28. Instead, the Examiner finds that Booth’s balloon could be in a
subcutaneous tunnel when the catheter is in a medically appropriate working
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position (Ans. 4). Appellant has not shown that Booth’s catheter could not
be inserted in a medically appropriate working position with the balloon in a
subcutaneous tunnel.
Appellant also argues that Booth fails to enable the claimed invention
(App. Br. 12). However, claims 1 and 14 are both directed to a product.
They do not require that the expandable chamber be in a subcutaneous
tunnel; instead they require that the expandable chamber could be in a
subcutaneous tunnel. Thus, to anticipate these claims, Booth need not teach
or enable placing the expandable chamber in a subcutaneous tunnel.
With regard to claim 14, Appellant additionally argues that “a
hemodialysis catheter is not . . . a cardiopagio catheter . . . . and is structured
differently [there]from” (App. Br. 11). However, Appellant has not pointed
to any specific structural difference between Booth’s catheter and a catheter
that could be used for hemodialysis. Therefore, we are not persuaded by this
argument.
Conclusion
Appellant has not shown that the Examiner erred in finding that Booth
discloses a catheter having an expandable chamber attached to the catheter at
a position that could be placed in a subcutaneous tunnel when the catheter is
in a medically appropriate working position and/or a catheter that could be
used for hemodialysis. We therefore affirm the anticipation rejection of
claims 1 and 14 over Booth. Claims 6, 8-10, 13, 15, 17, 21, 27, 29, and 33-
38 have not been argued separately and therefore fall with claims 1 and 14.
37 C.F.R. § 41.37(c)(1)(vii).
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Appeal 2009-000693
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For the same reasons, Appellant has not shown that the Examiner
erred in concluding that dependent claims 7, 11, 12, 18-20, 30-32, and 39
would have been obvious over Booth in view of Evans. We therefore also
affirm the obviousness rejection of these claims.
TIME PERIOD FOR RESPONSE
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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