Ex Parte Tsugita

Board of Patent Appeals and Interferences

Jul 30, 2012

10621972 (B.P.A.I. Jul. 30, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/621,972 07/17/2003 Ross S. Tsugita 1001.1421103 2230
11050 7590 07/30/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
BLATT, ERIC D
ART UNIT PAPER NUMBER
3734
MAIL DATE DELIVERY MODE
07/30/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROSS S. TSUGITA
__________

Appeal 2011-007154
Application 10/621,972
Technology Center 3700
__________

Before LORA M. GREEN, STEPHEN WALSH, and ULRIKE W. JENKS,
Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims directed to a medical device for use in a body
lumen. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
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Application 10/621,972

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STATEMENT OF THE CASE
Claims 53-71 and 78-80 are on appeal, and can be found in the
Appendix of the Appeal Brief. (App. Br. 20-24.) Claims 53 and 68 are
independent claims. Claim 53 is representative of the claims on appeal, and
reads as follows (emphasis added):
53. A medical device for use in a body lumen, the device
comprising:
a first catheter shaft having a proximal end region, a distal end
region, and a fluid lumen connecting the proximal end region and the
distal end region;
a second catheter shaft slidably disposed within the first
catheter shaft;
a guidewire slidably disposed in a lumen of the second catheter
shaft;
a filter coupled to the guidewire;
a balloon coupled to the distal end region of the first catheter
shaft;
a stent disposed adjacent the second catheter shaft,
wherein the balloon and the first catheter shaft are configured
to stop fluid outside of the first catheter shaft proximal to the balloon
from flowing distally past the distal region of the shaft when the
balloon is expanded;
wherein the stent is self-expanding and configured to be
deployed from a position between the distal end of the first catheter
shaft and the filter; and
wherein the first catheter shaft defines a perfusion lumen
configured for the passage of perfusing fluid supplied at the proximal
end region therethrough so as to flush embolic debris into the filter.

The following grounds of rejection are before us for review:
The Examiner has rejected claim 63 under 35 U.S.C. § 112 first
paragraph as failing to comply with the written description requirement.
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Application 10/621,972

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The Examiner has rejected claims 53-58, 60-65, and 68-71 under
35 U.S.C. § 103(a) as unpatentable over Gray1 in view of Patel.2
The Examiner has rejected claims 59, 66, 67, and 78-81 under
35 U.S.C. § 103(a) as unpatentable over Gray in view of Patel and further in
view of Dubrul.3

ISSUE (Obviousness)
The Examiner takes the position that it would have been obvious to
use a guiding catheter with a balloon as taught by Patel with the dilating
catheter as taught by Gray. (Ans. 4.) The Examiner takes the position that
the claim “language requires only that the balloon and the first catheter shaft
are configured to stop fluid outside of the first catheter shaft from flowing
distally past the distal region of the shaft. Blood that flows into port 27 is
not outside of the first catheter shaft.” (Ans. 5.) “The Examiner broadly
interprets the term ‘fluid outside of the first catheter shaft’ to include only
fluid that is outside the first catheter shaft at any given instant.” (Ans. 7.) It
is the Examiner’s position that if the side hole in Patel were not present then
the blood flow would be occluded by the inflated balloon. (Ans. 10.)
Appellants contend that Patel does not stop blood from outside the
first catheter shaft from distally flowing past the region were the balloon is
engaged. (App. Br. 13.) Appellants contend that the Examiner’s position
“rests upon an incorrect assumption that Patel discloses an embodiment in

1 Gray et al., WO 99/22673, published May 14, 1999
2 Patel, US 4,832,028, issued May 23, 1989
3 Dubrul, US 6,258,115 B1, issued Jul. 10, 2001
Appeal 2011-007154
Application 10/621,972

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which the side hole 27 is not present.” (Reply Br. 9.) Appellants
acknowledge that although Patel’s balloon “may somewhat obstruct blood
flow, it does not appear to stop the flow and stopping the bypass flow would
be counter to the explicit teachings of Patel that flow from the aorta into the
coronary artery distally past the tip is to be maintained.” (App. Br. 13.)
The dispositive issue is whether the combination of Gray and Patel
meet the claim limitation “wherein the balloon and the first catheter shaft are
configured to stop fluid outside of the first catheter shaft proximal to the
balloon from flowing distally past the distal region of the shaft when the
balloon is expanded.”

FINDINGS OF FACT
FF1. Patel disclosed a guide catheter that was stabilized in the coronary
artery by expanding a balloon so that it made contact with the inner surface
of the coronary artery. A dilating catheter was then passed through the
lumen of the guiding catheter to the lesion. (Patel col. 1, ll. 47-52.)
FF2. Patel disclosed that “[t]he side hole 27 passes through the guiding
catheter 11 to allow blood to flow from the aorta 13, through the side hole
27, and out the tip 21 of the guiding catheter 11.” (Patel col. 2, ll. 20-23.)
FF3. “Blood is perfused through the side hole 27 and the tip 21 of the
guiding catheter 11 into the main coronary 19. Blood flow is thus not
restricted by the inflated balloon 25 on the guiding catheter 11.” (Patel col.
2, ll. 65-68.)
FF4. Gray disclosed a catheter guide wire that contained a collapsible filter
for the collection of particulate matter from a stenotic lesion. (Gray 6, ll. 24-
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28.) Gray disclosed a treatment catheter for delivery of a balloon or stent.
(Id. ll 15-20.)

PRINCIPLES OF LAW
“The Patent Office has the initial duty of supplying the factual basis
for its rejection. It may not . . . resort to speculation, unfounded assumptions
or hindsight reconstruction to supply deficiencies” in the cited references. In
re Warner, 379 F.2d 1011, 1017 (CCPA 1967). “A proper § 103 analysis
requires “a searching comparison of the claimed invention – including all its
limitations – with the teaching of the prior art.” In re Ochiai, 71 F.3d 1565,
1572, (Fed. Cir. 1995).

ANALYSIS
Obviousness over Gray in view of Patel
The claims are directed to a medical device that is made up of two
catheters were the second catheter is slidably disposed inside the first
catheter. Both independent claims contain the limitation “wherein the
balloon and the first catheter shaft are configured to stop fluid outside of the
first catheter shaft proximal to the balloon from flowing distally past the
distal region of the shaft when the balloon is expanded.” We interpret this to
mean that once the balloon of the guide catheter is engaged with the vessel
wall, blood flow past the balloon is stopped in the vessel.
The Examiner’s position is that Patel disclosed using a guiding
catheter to help direct and position the dilating catheter in vessels. The
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Examiner asserts that using a guiding catheter with the dilating catheter of
Gray would have the same advantage. (Ans. 4.)
Appellants contend that Patel does not disclose stopping fluid outside
the first catheter from flowing distally past the region were the balloon is
expanded. (App. Br. 13.)
We agree with Appellant that combining Gray and Petal does not
result in a medical device made up of two catheters where the second
catheter is slidably disposed inside the first catheter and where the balloon
on the first catheter (or guiding catheter) would stop blood from flowing past
the balloon. Gray and Petal do not combine to produce a catheter that
restricts the blood flow past the balloon on the guiding catheter. Patel
requires a side hole in the guide catheter for the specific purpose of
providing blood flow downstream of the balloon (FF2, FF3). Thus, the
combination of Gray and Patel does not meet the limitation “wherein the
balloon and the first catheter shaft are configured to stop fluid outside of the
first catheter shaft proximal to the balloon from flowing distally past the
distal region of the shaft when the balloon is expanded.”
The Examiner finds that “were the side hole 27 not present, blood
flow would be occluded by the inflated balloon 25.” (Ans. 10.) Appellants
assert that restricting the blood flow as proposed by the Examiner would
alter the operating principle of the Patel catheter. (Reply Br. 9.) The
Examiner has not established that there would have been a reason to close
the side hole in Patel. We reverse the rejection.

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Obviousness over Gray in view of Patel in further view of Dubrul
Gray and Petal do not meet the claim limitation “wherein the balloon
and the first catheter shaft are configured to stop fluid outside of the first
catheter shaft proximal to the balloon from flowing distally past the distal
region of the shaft when the balloon is expanded.” Dubrul is directed to
thermally expanding stents and thus does not remedy the deficiency of the
missing claim limitation directed to stopping the blood flow distally past the
balloon. We find that the Examiner has not set out a prima facie case for
obviousness. We reverse the rejection.

CONCLUSION OF LAW
The preponderance of evidence on this record fails to support the
Examiner's finding that Gray in view of Patel suggests Appellants' claimed
invention of two slidably disposed catheters were the balloon on the outer
catheter stops blood flow from flowing past the balloon. The rejection of
claim 53 under 35 U.S.C. § 103(a) as obvious is reversed. Since the claims
stand and fall with claim 53, we also reverse the rejection of claims 54-71
and 78-80.

ISSUE (Written Description)
The Examiner takes the position that there is insufficient written
description in the original disclosure for the limitation of “an infusion port
on the first catheter located at the proximal end region.” (Ans. 3.)
Appellants contend that “[t]he term ‘infusion port’ is used in the art to
indicate a port at the proximal end of a catheter through which the
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medications, parenteral nutrition, or IV solutions to be infused are
introduced from outside the body.” (Reply Br.2.)
The dispositive issue is whether the ordinary artisan would understand
from the specification as filed that the “infusion port” is located at the
proximal end region of the catheter.

FINDINGS OF FACT
FF5. “[T]he guiding catheter includes an infusion port proximal to the
occlusion balloon. The port communicates with an infusion lumen in the
catheter and is adapted for infusion of fluid or pharmaceutical agents.”
(Spec. 7, ll. 11-13.)

ANALYSIS
Written Description
The Examiner asserts that there is a lack of written description for an
“infusion port within the proximal end region.” (Ans. 3.) The Examiner’s
position is that the “original disclosure discussed only an infusion port on
the first catheter located at the distal end region of the first catheter” citing to
Figure 5 of the Specification (Ans. 3.) The Examiner admits that “the
entirety of the catheter that lies proximal to the balloon 25 is considered to
comprise a proximal end region and the entirety of the catheter that lies
distal to the balloon 25 is considered to comprise a distal end region.” (Ans.
10.)
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Appellants assert that the skilled artisan would appreciate that the
infusion port would be at the proximal end of the catheter so that
pharmaceutical agents can be supplied from outside the body. (App. Br. 11.)
We agree with Appellants that the original disclosure provides
sufficient description for the limitation of an “infusion port within the
proximal end region.” The originally filed claims make reference to an
“infusion port proximal to the occlusion balloon.” (Spec. 21, claim 12.) By
the Examiner’s own admission this would be considered to be the proximal
end region of the catheter. (Ans. 10.) The Specification provides that the
infusion port is used to supply fluid and pharmaceutical agents through the
guiding catheter. (FF5.) The ordinary artisan would understand that in
order to supply pharmaceutical agents the infusion port would have to be
placed in such a way that the port would be accessible from outside the
body, which would be the proximal end of a catheter. Thus, we reverse the
rejection of claim 63 on the basis of lack of written description.

SUMMARY
We reverse the rejection of 63 under 35 U.S.C. §112 first paragraph.
We reverse the rejection of 53-58, 60-65, and 68-71 under 35 U.S.C.
§103(a) as unpatentable over Gray in view of Patel.
We reverse the rejection of 59, 66, 67, and 78-81 under 35 U.S.C.
§103(a) as unpatentable over Gray in view of Patel and further in view of
Dubrul.

REVERSED
Appeal 2011-007154
Application 10/621,972

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