Ex Parte Schreiner

Board of Patent Appeals and Interferences

Mar 28, 2012

11047220 (B.P.A.I. Mar. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN SCHREINER
__________

Appeal 2011-000359
Application 11/047,220
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E.ADAMS, and DEMETRA J. MILLS,
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 1-12, directed to an elongated flexible guide wire for positioning a
catheter. The claims have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.

Appeal 2011-000359
Application 11/047,220

2
STATEMENT OF THE CASE
The present invention is directed to “an elongated flexible guidewire
designed for insertion into blood vessels to aid in positioning a catheter
within the vessel” (Spec. 2: 15-16). The guidewire “is constructed from a
flexible corewire having a first constant diameter that extends over a major
portion of the guidewire from a proximal end to a distal region of the
guidewire” (id. at 2: 19-21). The corewire is “formed of a superelastic
material, such as Nitinol which extends for the entire length of the
guidewire” (id. at 3: 7-8). “[T]o increase the „torqueability,‟ or the ability of
the distal tip to be oriented by twisting the proximal end of the guidewire,
the proximal portion of the Nitinol corewire is ground down to a reduced
diameter and a . . . hypotube is placed over this portion of the core” (id. at 3:
8-11).
Claims 1-12 are pending and on appeal. Appellant does not present
separate arguments for the claims. Therefore, we select claim 1 as
representative of the subject matter on appeal, and the remaining claims will
stand or fall accordingly. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 reads as
follows (emphases added):
1. An elongated flexible guidewire having a proximal end, the
guidewire comprising:
a flexible corewire formed from a superelastic material and having a
first constant diameter portion extending from the proximal end of the
guidewire and that tapers distally along a first tapered portion to a second
lesser constant diameter portion shorter than said first diameter portion and
that again tapers distally along a second tapered portion to a flattened distal
portion of said corewire, said first constant diameter portion having a
proximal section having a reduced diameter section;
a hypotube extending over said reduced diameter section of said first
constant diameter portion and being bonded to said reduced diameter
section;
Appeal 2011-000359
Application 11/047,220

3
a flexible coil surrounding the corewire and attached to the corewire
along a length of the second lesser constant diameter portion of the corewire
and attached to a distal end of the flattened distal portion of the corewire;
and,
a polymer coating covering an outer surface of said guidewire
extending over a major portion of the guidewire.
Claims 1-12 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Esselstein et al. (US 6,638,267 B1, October 28, 2003), Fleischhacker,
(US 5,069,217, December 3, 1991), Leary (US 4,545,390, October 8, 1985),
and Box et al. (US 4,846,186, July 11, 1989).
ISSUE
The Examiner finds that Esselstein “discloses a guidewire with a
proximal end which is inserted into a hypotube comprising a flexible
guidewire distal portion formed from a superelastic material” (Ans. 4), with
“a hypotube extending over a reduced diameter section of the guidewire
distal portion . . . ; a flexible coil surrounding the core wire . . . ; and a
polymer coating on the hypotube of the guidewire” (id.). The Examiner
finds that “Esselstein teaches the use of a[n] insert . . . in [the] proximal
hypotube in order to provide increased pushability, torqueability and general
structural integrity of the hypotube in order to prevent kinking of the
guidewire” (id. at 7), but acknowledges that Esselstein does not disclose a
corewire extending from the proximal end of the guidewire and running
through the hypotube.
However, the Examiner finds that Leary discloses “a core wire which
is inserted into a hypotube and extends from the proximal end of the
guidewire” (id. at 5). The Examiner concludes that it would have been
obvious “to modify Esselstein‟s guidewire so that the core wire extends
proximal the guidewire through the hypotube” (id.), since “Esselstein‟s
Appeal 2011-000359
Application 11/047,220

4
essential teaching is to provide a solid core wire insert . . . into the proximal
hypotube in order to provid[e] increased structural integrity to the hypotube,
preventing kinking of the guidewire” and “a core wire [inserted] through a
hypotube, such as . . . taught by Leary, provides the same function” (id. at
7). Essentially, the Examiner‟s position is that “the proximal portion of the
core wire within the hypotube disclosed in Leary acts as Esselstein‟s insert”
(id.).
Appellant acknowledges that Leary “discloses a steerable guide wire
for balloon dilation procedures wherein the core wire extends through a
hypotube” (App. Br. 9), but contends that “[t]here is no apparent reason to
combine the elements of the claimed invention based on the art cited . . . .
Instead, there is an important reason not to combine the art cited, mainly
because Esselstein discloses the solution to a problem which would be faced
by the device disclosed in Leary” (id. at 9), and therefore, “teaches against
this claim recitation” (id. at 7).
The issue raised by this appeal is whether the Examiner has
established that it would have been obvious for one skilled in the art to
extend the proximal end of Esselstein‟s flexible corewire all the way to the
proximal end of the hypotube at the proximal end of Esselstein‟s guidewire,
essentially taking the place of Esselstein‟s insert, given the teachings of
Leary.
FINDINGS OF FACT
1. Esselstein teaches that “a guidewire should have sufficient
strength and elasticity to impart suitable pushability, . . . torqueability,
flexibility and handleability” “in order to reach the desired treatment
location” (Esselstein, col. 1, ll. 9-13).
Appeal 2011-000359
Application 11/047,220

5
2. According to Esselstein,
It has proven challenging to maximize these functional
characteristics while maintaining the necessary overall
dimensions. One prior art guidewire design utilizes a proximal
hypotube portion. Although this design offers advantages, it
also suffers from certain drawbacks. Most significantly, the use
of a hypotube increases the chance the guidewire will kink as it
is being advanced within the vasculature or through a guiding
catheter. In addition, due to the reduced cross sectional area
relative to a solid wire of the same outer diameter, such
hypotube guidewires generally suffer from similarly reduced
torqueability.
(Esselstein, col. 1, ll. 14-24.)
3. Esselstein‟s solution to these problems is “an internal insert
disposed within the interior hypotube” (Esselstein, col. 1, ll. 37-38), as
depicted in Figures 1 and 2, reproduced below:

Figure 1 depicts a “guidewire 10 compris[ing] an elongated, proximal
hypotube portion 11 and a relatively short distal portion 12. As shown more
clearly in FIG. 2, an insert 13 is disposed within proximal hypotube portion
11” (id. at col. 2, ll. 13-16). “The proximal end of distal portion 12 is
configured to permit insertion into the distal end of hypotube 11” and “[t]he
ends may be press fit, secured by crimping or swaging or by . . . a suitable
Appeal 2011-000359
Application 11/047,220

6
adhesive or by welding, brazing or soldering” (id. at col. 2, ll. 18-24).
“Insert 13 . . . preferably is composed of metals such as stainless steel, shape
memory/superelastic materials such as nickel-titanium alloys [i.e., Nitinol],
composite materials or polymeric materials” (id. at col. 2, ll. 39-42).
4. Esselstein teaches that “[i]nsert 13 provides additional
structure to hypotube 11, helping to prevent kinking as guidewire is
advanced through a patient‟s vasculature. Further, insert 13 can increase the
stiffness of hypotube 11 to improve the pushability of the guidewire . . . [and
may] also be used to increase the torqueability of the guidewire” (Esselstein,
col. 2, ll. 43-48).
5. Leary discloses a guide wire which “includes a main rod or
wire of a small diameter which extends substantially the full length of the
guide wire” (Leary, col. 2, ll. 15-16).
6. Leary teaches that “[a] high degree of torque control is provided
by the rotationally rigid wire which makes up the major portion of the length
of the guide wire . . . [which] assures that most of the torque applied at the
proximal end will be transmitted fully to the distal region” (id. at col. 2, ll.
37-42).
7. Leary discloses an embodiment in which “the proximal portion
of the wire is formed from a composite including a length of hollow outer
hypodermic tubing” and a safety wire. The wire extends through the
hypotube and is secured to the hypotube at its proximal end by a weld
(Leary, col. 6, ll. 43-51).
DISCUSSION
We agree with the Examiner that it would have been obvious for one
of ordinary skill in the art to extend the proximal end of Esselstein‟s flexible
Appeal 2011-000359
Application 11/047,220

7
corewire all the way to the proximal end of the hypotube at the proximal end
of Esselstein‟s guidewire, essentially taking the place of Esselstein‟s insert,
given the teachings of Esselstein and Leary. That is, we agree with the
Examiner that it would have been obvious “to modify Esselstein‟s guidewire
so that the core wire extends proximal the guidewire through the hypotube”
(Ans. 7), because Esselstein teaches that inserting a section of superelastic
solid core wire into the proximal hypotube provides increased structural
integrity to the hypotube portion of the guidewire and increases the
pushability and torqueability of the guidewire throughout its length (FF4),
while Leary‟s wire “provides essentially the same function” (Ans. 7; FFs 6,
7). We are not persuaded otherwise by Appellant‟s arguments.
Appellant contends that Esselstein “discloses that guidewires which
utilize proximal hypotube portions suffer from certain drawbacks . . .
includ[ing] the increased chance that the guidewire will kink and decreased
torqueability” (App. Br. 6). Appellant contends that Esselstein “discloses a
single solution” to overcome these drawbacks, specifically, “[i]nsert 13 is
disposed within the proximal hypotube portion 11 to provide additional
structure to hypotube 11” and “prevents kinking of the guidewire, improves
pushability and increases torqueability” (id. at 7).
Appellant contends that “U.S. Patent 5,480,382, referenced by the
applicants of Esselstein as relevant prior art during prosecution of Esselstein,
discloses a steerable medical device where the pull wire 188 extends
proximally through the hypotube 181” (id.).
Appellant contends that
A person of ordinary skill in the art, knowing that Esselstein
discloses an insert in a hypotube to specifically overcome the
deficiencies of prior art such as U.S. Patent 5,480,382, would
Appeal 2011-000359
Application 11/047,220

8
not be taught, suggested or motivated to combine Esselstein
with Leary . . . because the person of ordinary skill in the art
would be ignoring the solution to the problem faced in the prior
art, the solution to which (insert 13) is the main thrust of the
Esselstein application and excludes a corewire extending
proximally through a hypotube.
(Id. at 7-8.)
Appellant‟s arguments are not persuasive. While the title page of
Esselstein lists US Patent 5,480,382 (Hammerslag et al., January, 1996) as a
reference considered during examination of the Esselstein application, its
relevance to Esselstein‟s invention is not discussed in Esselstein‟s
disclosure. Moreover, there is absolutely no indication in Esselstein that the
prior art devices discussed in its “Background of the Invention” section had
anything at all running through their hollow “proximal hypotube portion[s]”
(see Esselstein, col. 1, ll. 5-24), thus we find no factual basis for Appellant‟s
assertion that “Esselstein discloses an insert in a hypotube to specifically
overcome the deficiencies of prior art such as U.S. Patent 5,480,382” (App.
Br. 8). Therefore, we are not persuaded that Esselstein teaches away from
the modification proposed by the Examiner.
Finally, Appellant contends that Leary “does not disclose a flexible
coil which is attached to the distal end of the corewire” (App. Br. 9), Box
“does not disclose a hypotube” (id. at 10), and Fleischhacker “discloses a
steerable guidewire that does not include a hypotube and discloses that the
flexible coil spring should be attached to a tapered region . . . not a . . .
constant diameter portion” (id.).
Appellant‟s argument is not persuasive. As the Examiner points out,
“the primary Esselstein reference . . . teaches the features the applicant
argues are not present in the supporting references” (Ans. 8).
Appeal 2011-000359
Application 11/047,220

9
SUMMARY
The rejection of the claims under 35 U.S.C. § 103(a) as unpatentable
over Esselstein, Fleischhacker, Leary, and Box is affirmed.
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

cdc