Ex Parte Khieu et al

Board of Patent Appeals and Interferences

May 21, 2012

11647278 (B.P.A.I. May. 21, 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.
11/647,278 12/29/2006 Xuan Khieu 0B-049201US-
82410.0141
1513
55962 7590 05/21/2012
SJM/AFD-WILEY
Legal Department
One St. Jude Medical Drive
St. Paul, MN 55117-9913
EXAMINER
STIGELL, THEODORE J
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
05/21/2012 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 XUAN KHIEU, RICHARD E. STEHR,
THAO T. NGUYEN and LINDA NEMEC
__________

Appeal 2011-003162
Application 11/647,278
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and ERICA A.
FRANKLIN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims related to a
catheter, which the Examiner has rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification states that, in procedures in which an introducer
catheter is used to guide an ablation catheter to a location in the heart
(Spec. 2, ¶ 4), the distal tip of the introducer catheter can become occluded
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Application 11/647,278

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(id. at 2, ¶ 6). “Because an ablation catheter . . . is cooled in part by the flow
of blood through [the] introducer’s interior lumen, an occluded distal end
would impede the flow of blood and interfere with the temperature control
of the ablation device” (id. at 3, ¶ 7). The Specification discloses “aspiration
passageways [that] function as relief holes in the side of the introducer
catheter which allow for the flow of blood into an interior lumen and
through the catheter when the distal end of the catheter is occluded” (id.).
Claims 43-50, 52-62, 71-79, 81-87, and 89-92 are on appeal. Claim
43 is representative and reads as follows:
43. A kit for use in a transseptal procedure, comprising:
a catheter having a proximal and a distal end, an outer surface, and at
least one interior lumen extending from the proximal end through a region
near the distal end, wherein the outer surface includes multiple aspiration
passageways in fluid communication with an interior lumen and positioned
near the distal end, and
a guidewire, having a guide wire diameter, over which the catheter
may be introduced into a patient’s vasculature,
wherein each of the aspiration passageways has a diameter greater
than about 0.01 inches and less than the guide wire diameter.
Claims 52 and 71, the only other independent claims, also require a
catheter having aspiration passageways with a diameter between 0.01 inches
and the guidewire diameter. The Specification states that the guidewire
typically used with transseptal introducers has a diameter of 0.032 inches
(Spec. 11, ¶ 26).
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The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 43-45, 48-50, 52, 53, 56-62, 71-79, 82-87, and 89-92 based
on Cragg1 (Answer 4) and
• Claims 43, 44, 46-50, 52-62, 71-79, 81-87, and 89-92 based on
Samson2 (Answer 5).3
I.
The Examiner has rejected claims 43-45, 48-50, 52, 53, 56-62, 71-79,
82-87, and 89-92 as obvious based on Cragg. The Examiner finds that
Cragg discloses most of the limitations of the claimed kit but “the
perforations in Cragg are disclosed as being smaller than the recited
dimensions” (Answer 4). The Examiner concludes, however, that a catheter
having the recited passageways would have been obvious because “[i]t is not
outside the skill of an ordinary artisan to scale up or down” (id.) and “if the
embodiment disclosed in Cragg was scaled up to make a bigger catheter, the
perforations would also be made bigger to adjust to the greater flow rate
provided by the bigger diameter of the catheter” (id. at 4-5).
Appellants argue that “Cragg expressly teaches that the perforations
are configured such that ‘thrombolytic agent is ejected therethrough as fine,
high velocity, power lysis jets’” and that “increasing the size of Cragg’s
perforations as suggested by the Examiner would defeat this object of
Cragg” (Appeal Br. 11). Appellants also argue that “Cragg does not teach or

1 Cragg et al., US 6,635,027 B1, issued Oct. 21, 2003
2 Samson et al., US 6,197,014 B1, issued Mar. 6, 2001
3 Claims 93 and 94 are also pending (Appeal Br. 4) but are not included in
either of the rejections in the Answer or in the rejections set out in the Office
action mailed Dec. 15, 2009, from which the appeal was taken.
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Application 11/647,278

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suggest any relationship between the size of the catheter and the size of the
perforations. Thus, it is pure speculation for the Examiner to conclude that
scaling up the size of the catheter necessarily scales up the size of the
perforations.” (Id.)
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). In this case, we agree with Appellants that the Examiner has not
shown that a catheter having passageways in the size range required by the
claims on appeal would have been obvious based on Cragg.
The claims are directed to a kit that includes a catheter having
aspiration passageways with a diameter between 0.01 inches and the
guidewire diameter (typically 0.032 inches). Cragg discloses an apparatus
that includes a catheter having “multiple side wall perforations or infusion
holes” (Cragg, col. 3, ll. 58-59). Cragg states that the holes “are preferably
about 0.01 cm (0.005 inches) in diameter” (id. at col. 7, ll. 1-2); in other
words, Cragg’s holes are preferably half the minimum diameter required by
the claims on appeal.
Cragg discloses that the infusion holes are “relatively minute, and
their size meters the ejection of the infusate therefrom” (id. at col. 7, ll. 13-
15). As a result, the “bolus volume is ejected or emitted . . . as high velocity,
low volume, lining penetration jets that penetrate the adjacent endothelial
layer” (id. at col. 3, ll. 57-62). Cragg also discloses that the “ejection
velocity of the lining penetrating jet is . . . inversely proportional to the total
outflow area” (id. at col. 4, ll. 10-13).
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Thus, Cragg discloses that its catheter has relatively minute infusion
holes – preferably with a diameter half that required by the claims – for the
purpose of limiting the total outflow area in order to emit the infusate as
high velocity jets that will penetrate the adjacent endothelium. In view of
these disclosures, we agree with Appellants that increasing the size of the
infusion holes in Cragg’s device would defeat the object of generating high
velocity jets.
The Examiner has not provided any persuasive reason why a skilled
worker would have considered it obvious to modify Cragg’s apparatus to
include holes in the size range required by the claims on appeal. We
therefore reverse the rejection based on Cragg.
II.
The Examiner has rejected claims 43, 44, 46-50, 52-62, 71-79, 81-87,
and 89-92 as obvious based on Samson. The Examiner finds that Samson
discloses a kit comprising a guidewire and a catheter with passageways, but
does not teach that the passageways have the size recited in the claims on
appeal (Answer 5). The Examiner concludes that a catheter having the
recited passageways would have been obvious because
if the embodiment disclosed in Samson was scaled up to make a
bigger catheter, the perforations would also be made bigger to
adjust to the greater flow rate provided by the bigger diameter
of the catheter. Accordingly, the recited dimensions would
simply be design considerations determined by the desired size
of the catheter. Furthermore, it would be obvious to the
ordinary skilled artisan to change the size of the passageways to
control the pressure at which the infused drug exits the catheter.
(Id. at 6.)
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Appellants argue that “Samson does not teach or suggest any
relationship between the size of the catheter and the size of the perforations.
Thus, it is pure speculation for the Examiner to conclude that scaling up the
size of the catheter necessarily scales up the size of the perforations, or that
any such scaling would ultimately yield the claimed invention.” (Appeal Br.
12.)
We agree with Appellants that the Examiner has not set out a prima
facie case of obviousness based on Samson. Samson discloses “an infusion
catheter section made up of an inner liner and an outer covering and having
a super-elastic alloy ribbon braid located between the liner and the covering.
Located generally in the interstices between adjacent turns of the braid
ribbon are a number of infusion orifices.” (Samson, col. 4, ll. 58-63.)
Samson states that the orifices “are used to allow passage of
therapeutic and diagnostic fluids from the interior lumen of the catheter
section into the region outside the catheter section” (id. at col. 13, ll. 35-37).
Samson discloses that the orifices can be of different sizes (id. at col. 13,
ll. 53-54; col. 14, ll. 1-2), but does not describe the size of any of the
infusion orifices, or of the interstices between adjacent turns of the ribbon.
The Examiner has pointed to no evidence that orifices having a size in
the range recited in the claims are conventional, or would have been
recognized as suitable for infusion of therapeutic or diagnostic fluids in
Samson’s catheter. In the absence of evidence or persuasive technical or
logical reasoning to show that a skilled worker would have considered it
obvious to make Samson’s device with orifices in the size range required by
the claims on appeal, we are compelled to reverse the rejection based on
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Samson. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (“[T]he
examiner bears the initial burden, on review of the prior art or on any other
ground, of presenting a prima facie case of unpatentability. . . . After
evidence or argument is submitted by the applicant in response, patentability
is determined on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument.”).
SUMMARY
We reverse both of the rejections on appeal.

REVERSED

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