Ex Parte Miller

Board of Patent Appeals and Interferences

Aug 7, 2012

11147390 (B.P.A.I. Aug. 7, 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.
11/147,390 06/08/2005 Stuart H. Miller MILL-004 5220
21884 7590 08/07/2012
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
PANI, JOHN
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
08/07/2012 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 STUART H. MILLER
__________

Appeal 2011-003201
Application 11/147,390
Technology Center 3700
__________

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

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1, 4, 5, and 7-11, directed to a guidewire sheath. The claims have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
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STATEMENT OF THE CASE
In many medical procedures, “a device known as a sheath provides for
desired access to the interior of [a] blood vessel” (Spec. 2). “[A] needle is
generally used to obtain access to the interior of the blood vessel . . . [and]
[a] guidewire is inserted into the blood vessel through the needle and the
needle is removed” (id. at 3). Then, a sheath, which “generally consists of
two concentric plastic tubes” (id. at 2), is “threaded over the guidewire and
forced axially against the flesh of the patient until the tubes are inside the
blood vessel” (id. at 3).
Because the inner tube is longer than the outer tube (id. at 2), and
“[t]he ends of the inner and outer plastic tubes are [conventionally] circular
and in a plane perpendicular to the longitudinal axis of the respective plastic
tubes . . . step[s] [are created] at the ends of the inner and outer plastic tubes”
(id. at 2-3).
These abrupt “steps” increase the axial force required to insert the
sheath into the hole created by the needle, and consequently, increase the
pain and trauma experienced by the patient (id. at 3).
The Specification discloses a sheath which “effectively remove[s] the
undesirable ‘steps’ encountered in conventional sheaths by using pointed,
rather than blunt ends, at the ends of the inner and outer sheath members (or
tubes)” (id. at 9). Both the inner sheath and the outer sheath have the same
shape, i.e., each has “a primary bevel and a circumferential conical surface”
(id. at 5), resulting in “tapered, sharp cutting edges which will penetrate the
tissue more easily than sheaths of conventional design” (id. at 13-14). The
Specification teaches that “[t]he pointed ends provide the same overall radial
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Application 11/147,390

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deformation as conventional sheath members” (id. at 9), but “the magnitude
of the [insertion] force required . . . is greatly reduced since the total radial
deformation at the ‘step’ is spread incrementally along the length of the
points on the inner and outer members” (id.).
Claims 1, 4, 5, and 7-11 are pending and on appeal; claims 2, 3, and 6
have been canceled (App. Br. 3). Claim 1 is representative of the subject
matter on appeal:
1. A sheath shaped and dimensioned for reducing trauma and
easing insertion thereof, comprising:
an inner sheath member, the inner sheath member including an inner
sheath tip having a primary bevel and a circumferential conical surface, and
wherein the primary bevel of the inner sheath member extends diametrically
across the inner sheath member and the inner sheath tip is formed with a
long distal end that extends further than a diametrically opposed short distal
end, and wherein the conical surface of the inner sheath member varies
between the long distal end which has a first cone angle relative to a
longitudinal axis of the inner sheath member and the short distal end which
has a second cone angle relative to the longitudinal axis of the inner sheath
member, and the first cone angle is less than the second cone angle, and the
conical surface varies between the first cone angle and the second cone
angle as the conical surface transitions from a high at the second cone angle
adjacent the short distal end and a low at the first cone angle adjacent the
long distal end;
an outer sheath member shaped and dimensioned to fit around the
inner sheath member in a manner permitting relative movement, the outer
sheath member including an outer sheath tip having a primary bevel and a
circumferential conical surface, and wherein the primary bevel of the outer
sheath member extends diametrically across the outer sheath member and
the outer sheath tip is formed with a long distal end that extends further than
a diametrically opposed short distal end, and wherein the conical surface of
the outer sheath member varies between the long distal end which has a first
cone angle relative to a longitudinal axis of the inner sheath member and the
short distal end which has a second cone angle relative to the longitudinal
axis of the inner sheath member, and the first cone angle is less than the
second cone angle, and the conical surface varies between the first cone
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angle and the second cone angle as the conical surface transitions from a
high at the second cone angle adjacent the short distal end and a low at the
first cone angle adjacent the long distal end.
The claims stand rejected as follows:
Claims 1, 4, 5, 7, and 9-11 under 35 U.S.C. § 103(a) as unpatentable
over Suzuki (US 4,565,545, January 21, 1986); and
Claim 8 under 35 U.S.C. § 103(a) as unpatentable over Suzuki and
Gellman (US 5,057,083, October 15, 1991).
OBVIOUSNESS
Discussion
Claim 1 is directed to a sheath “shaped and dimensioned” to provide
easy insertion into a blood vessel, while minimizing trauma to the patient.
Suzuki discloses a “catheter insertion device” comprising an inner
needle 1 and an outer catheter 2, which is “capable of forming a smaller
incision in the blood vessel than the outside diameter of the inner needle
without the need for any [additional] dilator” (Suzuki, col. 2, ll. 44-47).
Specifically, Suzuki’s device integrates “the dilator and the inner needle by
forming the end of the inner needle into a taper and forming a beveled
surface in the vicinity of the tapered portion” (id. at col. 3, ll. 5-9).
The Examiner finds that “Suzuki discloses a sheath shaped and
dimensioned for reducing trauma and easing insertion thereof,” comprising
an inner needle 1, with a beveled conical tip that meets all the requirements
of the inner sheath of claim 1 (Ans. 3). The Examiner finds that Suzuki
discloses that its needle tip, with “the varying cone angle and bevel claimed”
(id. at 4), “combines both cutting and dilating properties into a single
structure,” which “allows the device to form a smaller incision in the blood
vessel than the outer diameter of the needle . . . [and] reduces pain
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experienced by the patient upon insertion while . . . maintain[ing]
hemostasis” (id.).
The Examiner further finds that Suzuki discloses an outer catheter 2,
“shaped and dimensioned to fit around the inner . . . [needle 1] in a manner
permitting relative movement” (id.). However, the Examiner concedes that
the outer catheter 2 is “not detailed as having the claimed tip” (id.).
Nevertheless, the Examiner reasons that one of ordinary skill in the art
would have recognized “that the benefits of the distal tip configuration of
inner needle 1 of Suzuki would . . . predictably result in similar benefits to
other blood vessel puncturing and accessing devices” (id. at 9). The
Examiner concludes that it would have been obvious for one of ordinary
skill in the art “to have modified the device of Suzuki by making the distal
tip of the outer catheter 2 have a similar shape to the needle 1 with a varying
cone angle and bevel at the distal end . . . as this modification would provide
that when the outer catheter entered the tissue and blood vessel, it would
enter through a smaller incision relative to its outer diameter, thus reducing
pain, while the tapering action would act as a dilator, thereby providing . . .
hemostasis” (id. at 4-5).
Appellant does not dispute that the shape and dimensions of Suzuki’s
needle meet the limitations of the inner sheath required by claim 1; nor does
Appellant dispute that Suzuki’s needle and the inner sheath of claim 1
function in the same way. Rather, Appellant contends that the Examiner
“overlooks the fact that elements 1 and 2 of Suzuki are structurally different.
In particular, element 1 is an inner needle while element 2 is an outer
catheter fitted on the outside of the inner needle” (App. Br. 12). Appellant
contends that “the catheter 2 and needle 1 of Suzuki are different structures
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performing different functions” (Reply Br. 2). Appellant contends that
“[t]he Examiner fails to present a rationale” as to why “a specific tip
structure . . . disclosed in conjunction with a needle . . . would be appropriate
for a catheter surrounding the needle” (App. Br. 13).
Nevertheless, the Examiner does present a rationale for giving
Suzuki’s outer catheter the same beveled conical structure as Suzuki’s inner
needle. As discussed above, the Examiner’s rationale is that one of ordinary
skill in the art would have recognized “that the benefits of the distal tip
configuration of inner needle 1 of Suzuki would . . . predictably result in
similar benefits to other blood puncturing and accessing devices” (Ans. 9).
We agree with the Examiner that this recognition would have given one of
ordinary skill in the art a reason “to modify the outer catheter 2 to have a
structure similar to that of inner needle 1 in order to provide similar benefits
to catheter 2” (id.).
Claims 4, 5, and 7-11:
Appellant does not present separate arguments for claims 8 and 9. As
for claims 4, 5, 7, 10, and 11, Appellant simply states the further limitations
added by each of these claims and asserts that “[t]he claimed invention does
not merely optimize the construction of the sheath but provides a highly
engineered sheath construction allowing for improved insertion in a manner
previously unknown in the prior art” (Appeal Br. 15).
However, these arguments do not meet the requirements of 37 C.F.R.
§ 41.37(c)(1)(vii). See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011)
(“[T]he Board [has] reasonably interpreted Rule 41.37 to require more
substantive arguments in an appeal brief than a mere recitation of the claim
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elements and a naked assertion that the corresponding elements were not
found in the prior art.”). Thus, claims 4, 5, and 7-11 fall with claim 1.
SUMMARY
The rejection of claims 1, 4, 5, 7, and 9-11 as unpatentable over
Suzuki is affirmed, as is the rejection of claim 8 as unpatentable over Suzuki
and Gellman.
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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