Ex Parte Turnbull

Board of Patent Appeals and Interferences

Sep 30, 2008

10290279 (B.P.A.I. Sep. 30, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHRISTOPHER STRATTON TURNBULL
__________

Appeal 2008-3477
Application 10/290,279
Technology Center 3700
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Decided: September 30, 2008
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Before DONALD E. ADAMS, ERIC GRIMES and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
tracheostomy apparatus. The Examiner has rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
Appeal 2008-3477
Application 10/290,279

BACKGROUND
In one technique for performing a percutaneous tracheostomy, a
needle is inserted into the trachea through an incision, then a cannula and
guidewire are inserted and the opening is expanded using a series of dilators
“until it is large enough to receive a percutaneous tracheostomy tube”
(Specification 1). “One problem with this technique is that there is a risk the
first dilator will be pushed in too far and contact the posterior wall of the
trachea, causing damage” (id.).
The Specification discloses a tracheostomy dilator having a “first,
patient end portion” that is “flexible and of substantially constant external
diameter,” and a second portion (extending rearwardly from the first portion)
that is “more rigid and tapering along at least a part of its length to a larger
diameter towards its rear end” (id. at 2).
DISCUSSION
1. CLAIMS
Claims 3-8, 11, 18-27, 32, and 34 are pending and on appeal. Claims
18 and 32 are representative and read as follows:
Claim 18: Apparatus, comprising:
a guidewire;
a dilator adapted to enter into the trachea of a patient and to dilate
neck tissue of the patient, said dilator having a first patient end portion and a
second portion extending rearwardly from said first portion, wherein said
first portion is flexible and of substantially constant external diameter and
said second portion is more rigid and tapers along at least a portion of its
length to a larger diameter towards its rear end, wherein a length of said first
portion is at least as long as a taper of said second portion,
a bore extending along said dilator through which said guidewire is
extendable; and
a needle having a tip extending from a hub;
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wherein said apparatus is used to enter the trachea, after said needle is
fitted to said dilator until said hub abuts a rear end of said dilator, by
inserting the needle fitted dilator to the trachea until said second portion of
said dilator is adjacent to neck of the patient so that a tip of said first portion
and the tip of said needle are positioned in the trachea and spaced from a
posterior wall of the trachea; and
wherein said apparatus is used for dilating the neck tissue of the
patient after said needle is removed from said dilator and said guidewire is
inserted through said dilator to the trachea, so that said dilator is guided by
said guidewire to be further inserted in the trachea until said tapered portion
lies within the trachea to thereby dilate the neck tissue.

Claim 32: A method of performing a percutaneous tracheostomy on a
patient using a dilator having a first patient end portion and a second portion
extending rearwardly from said first portion, comprising the steps of:
a) fitting to said dilator a needle until tip of said needle is exposed
from forward end of said first portion;
b) inserting the needle fitted dilator to trachea of the patient through
the neck tissue of the patient until the tip of said needle and the forward end
of said first portion are positioned in the trachea but with said second portion
outside the neck of the patient;
c) replacing said needle with a guidewire in said dilator; and
d) inserting said dilator guided by said guidewire further toward the
trachea to expand the neck tissue of the patient,
wherein said step (d) further comprises the step of:
inserting the dilator toward the trachea of the patient until a tapered
portion of said second portion lies within the trachea.

2. ANTICIPATION
Claim 32 stands rejected under 35 U.S.C. § 102(b) as anticipated by
Sauer.1 The Examiner finds that “Sauer discloses a method of performing a
percutaneous tracheostomy using a dilator” that meets all the limitations of
claim 32 (Answer 3-4, citing Sauer, col. 7, ll. 19-58; Figs. 9 and 10).

1 Sauer et al., US 5,690,669, Nov. 25, 1997.
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We agree with the Examiner that Sauer discloses all of the limitations
in claim 32. Sauer discloses “a surgical apparatus for manipulating body
tissue” (Sauer, abstract) and “the use of the apparatus in conjunction with a
novel method for performing a tracheostomy” (id. at col. 7, ll. 20-22). Sauer
discloses the use of a dilator to initiate the tracheostomy as shown in Figures
9 and 10, which are reproduced below.

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Figure 9 shows a dilator, with a syringe/needle inserted through the
dilator so that the needle extends through the front end of the dilator; the
dilator/needle are partially inserted into the trachea of a patient. Figure 10
shows the dilator more fully inserted into the trachea, with the
syringe/needle replaced by a guidewire extending from the front end of the
dilator and into the trachea.
Sauer describes the method of performing a tracheostomy as follows:
[A]n incision is made at the desired location adjacent the
cricoid cartilage “c”. A dilator “d” is then positioned over the
needle portion “n” of a syringe “s”. The needle portion “n”
having the dilator “d” positioned thereover is inserted within
the trachea as shown in FIG. 9. . . . During the initial insertion
step (shown in FIG. 9), dilator “d” is inserted a predetermined
distance whereby only the first diameter portion “d1” penetrates
the trachea and engages the adjacent tracheal rings. . . . The
syringe “s” is then removed leaving dilator “d” in place within
the adjacent tracheal rings. After the needle portion “n” is
removed, the surgeon advances the dilator “d” within the
tracheal area until its second larger diameter portion “d2”
engages the adjacent rings as shown in FIG. 10.

Referring still to FIG. 10, a guide wire “w” is positioned within
a bore defined in dilator “d” and the guide wire “w” is advanced
distally within the dilator “d” until a distal portion of the guide
wire “w” is within the trachea of the patient. It is to be noted
that the guide wire “w” may be inserted prior to advancing
dilator “d” within the trachea to its second diameter portion
“d2”.

(Sauer, col. 7, ll. 23-57.)
Appellant argues that the process described by Sauer does not meet
the limitation of claim 32 that “calls for inserting the needle fitted dilator to
the trachea of the patient through the neck tissue of the patient until the tip of
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the needle and the forward end of the first portion are positioned in the
trachea but with said second portion outside the neck of the patient” because
Fig. 9 of Sauer “shows the tapered portion of the Sauer dilator portion ‘d2’ to
be located inside the neck of the patient, in contrast to the ‘outside the neck’
requirement in step (b) of claim 32” (Appeal Br. 11).
Appellant argues that this distinction is significant because the
“claimed invention is used without any syringe, so that the user, but for the
fact that the second portion of the dilator remains outside the neck of the
patient, would not otherwise have been able to tell how far the dilator, and
the tip of the needle fitted within the dilator, have advanced into the trachea
of the patient” (id.). Thus, Appellant argues that “the second portion of the
dilator of the claimed apparatus acts as a stop, or a marking, to ensure that
the user does not advance the dilator too deeply into the trachea of the
patient to cause any damage” (id.).
The Examiner reasons that the claim recites that “the second portion
‘extends rearwardly from the first portion’ with no proximal limit as to how
far it can extend, thereby allowing a very broad interpretation of what the
second portion entails” and that the claim also recites that the second portion
has a “tapered portion” (Answer 7). The Examiner interprets the “second
portion” recited in claim 32 to be made up of the part d2 and the tapered area
between parts d1 and d2 in Sauer’s device (id. at 7-8). The Examiner
concludes that “when the tip of the needle (n) and the forward end of the
first portion (dl) are positioned in the trachea …, the second portion (d2) is
in fact located outside of the neck” because part of the second portion lies
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outside of the neck and the claim “does not require that the entire second
portion is located outside the neck” (id. at 8).
We agree with the Examiner’s reasoning and therefore are not
persuaded by Appellant’s argument. It is well settled that “claims in an
application are to be given their broadest reasonable interpretation consistent
with the specification and that claim language should be read in light of the
specification as it would be interpreted by one of ordinary skill in the art.”
In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983) (citation omitted).
In the instant case, claim 32 recites “a dilator having a first patient end
portion and a second portion extending rearwardly” from the first portion
and that a part of the second portion is tapered. The claim language does not
limit the second portion to being only a tapered portion, i.e., it can be
comprised of parts of different diameters. Consistent with this, the
Specification states that the second portion tapers “along at least a part of its
length to a larger diameter toward its rear end” (Spec. 2). Thus, we interpret
claim 32 to encompass a second portion made up of two parts of different
sizes and not to be limited to a tapered portion.
Thus, we agree with the Examiner that the “second portion” recited in
claim 32 reads on the part of Sauer’s device that includes “d2” and the
tapered portion between “d1” and “d2”. Claim 32 does not require that the
method be carried out without a syringe, as Appellant argues, and the
comprising language used in claim 32 encompasses other steps not expressly
recited. Because claim 32 does not include any limitations that distinguish
the claimed method from the method disclosed in Sauer, we agree with the
Examiner that claim 32 encompasses the method disclosed in Sauer.
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Appellant further argues that Sauer “fails to meet the limitations of
step (d), which requires that the dilator guided by the guidewire be further
inserted toward the trachea to expand the neck tissue of the patient” because
“the ‘d2’ portion of the dilator ‘d’ of Sauer already has been inserted within
the neck of the patient, per shown in Fig. 9, when the needle ‘n’ first enters
into the trachea [and this] means that the neck tissue already has been dilated
to its desired diameter, and thus needs no further expansion step” (Appeal
Br. 12).
We are not persuaded by this argument. As shown in Fig. 9 of Sauer
above, after the first insertion step, only a portion of the neck tissue has been
penetrated by the broadest tapered end of the second portion, and thus
further inserting the dilator will further expand the neck tissue, i.e. the
trachea and the neck tissue outside of the trachea. See Sauer, Fig. 10.
3. OBVIOUSNESS
Claims 3-8, 11, 18-27 and 34 stand rejected under 35 U.S.C. § 103 as
obvious in view of Sauer and Okada. 2 Claim 19 has been argued separately;
claims 3-8, 11, 20-27 and 34 stand or fall with claim 18. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner relies on Sauer as discussed above. The Examiner
finds that “Sauer does not disclose that the first portion is at least as long as
the taper of the second portion” (Answer 6).
The Examiner finds that Okada discloses “a catheter introducer that is
used with a guidewire and has a conical tip, which acts as a dilator,” with a
flexible first portion of constant diameter that is “at least as long as the

2 Okada, Eur. Pat. App. Pub. No. 0232994, Aug. 19, 1987
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second portion which is tapered and more rigid than the first” (Answer 6,
citing Fig. 5 and 7 of Okada). The Examiner also finds that Okada discloses
that “the flexibility reduces the chance of damage to the surrounding tissue
and the length of the first portion provides extra support for the guide wire to
prevent kinking or buckling” (id.).
The Examiner concludes that it “would have been obvious to one
having ordinary skill in the art … to enhance a tracheostomy assembly with
a longer flexible tip. The longer tip provides several advantages including
preventing kinking of the guidewire and reducing the chance of damage to
the tissue. Okada provides the motivation.” (Id.)
We conclude that the Examiner has set forth a prima facie case that
claim 18 would have been obvious to the ordinary artisan. Sauer is
discussed above. Okada discloses “a catheter introducer for use with a guide
wire and comprising a tubular body having an inwardly tapered tip, said tip
having a flexible snout adapted to follow the path of a guide wire” (Okada,
col. 1, ll. 31-35). Fig. 5 of Okada is shown below for reference:

Fig. 5 is said to show an axial section through the tip of an introducer that
“has a snout 42 of substantially constant inside and outside diameter, which
merges smoothly into the dilator 44” (id. at col. 2, ll. 10-12 and 53-55).
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Okada also discloses that the snout portion (42) is more flexible than
the tapered portion (44) (id. at col. 3, ll. 9-20; Fig. 7). Okada further
discloses that the “flexible snout ensures that the introducer is guided into a
puncture wound before the user applies additional force to dilate the
opening” and that a “further feature of the invention is that a smaller
diameter guide wire may be used because buckling is less likely; this has the
advantage that if the guide wire is misplaced or inadvertently punctures a
blood vessel wall less damage and trauma is caused to the patient” (id. at
col. 1, ll. 36-44).
We agree with the Examiner that it would have been prima facie
obvious to one of skill in the art to combine the teachings of Sauer and
Okaka and thereby arrive at the invention of claim 18. That is, it would have
been obvious to modify the first portion (“d1”) of the device disclosed by
Sauer to be flexible and to be at least as long as the tapered part of the
second portion (between “d1” and “d2”) because Okada teaches that these
properties make the guidewire less likely to buckle and reduce the chances
of injuring the patient.
Appellant argues that “Okada describes a catheter introducer that is
quite different from a tracheostomy dilator,” which “is used for insertion
into a blood vessel,” and that “the Okada catheter introducer is of
substantially smaller size and diameter than a dilator; and in all likelihood is
not fitted with a needle for insertion into the blood vessel of a patient”
(Appeal Br. 13). Appellant further argues that “[t]here is no disclosure or
suggestion in Okada that a needle be inserted initially within the catheter in
order to make the initial entry into the blood vessel” (id.). Thus, Appellant
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argues that “there is no suggestion or motivation provided by either Sauer or
Okada that they be combined as suggested by the examiner, as the Sauer
tracheostomy dilator and the Okada catheter introducer are very different
devices” (id. at 13-14).
We do not find these arguments to be persuasive. The question, with
respect to § 103, is whether a person of ordinary skill in the art would have
considered it obvious, based on the cited references, to modify the prior art
devices in such a way as to create a device within the scope of the claims.
Thus, in determining whether the references are from nonanalogous arts, the
question is whether the inventions disclosed by Sauer and Okada are in the
same field of endeavor or are reasonably pertinent to a particular problem.
See In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992).
We agree with the Examiner that the Sauer and Okada references are
not non-analogous art, because both references relate to the penetration of
body lumen (i.e. a trachea for Sauer and a blood vessel for Okada) using a
dilator and guidewires to expand an initial opening for insertion of a
therapeutic tube (i.e. a trachea tube for Sauer and a catheter for Okada). In
addition, Sauer recognizes “the potential of damaging underlying tissue
structure” (Sauer, col. 8, ll. 41-42) when inserting dilators during a
tracheostomy, confirming our conclusion that those of skill in the art would
have been motivated to combine Okada’s flexible snout with Sauer’s device
in order to minimize the risk of inadvertent damage.
Appellant further argues that “the combination of Sauer and Okada …
fails to teach the required limitation of claim 18 that the second portion of
the dilator be adjacent to the neck of the patient, when the dilator is inserted
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to the trachea of the patient so that the tip of the first portion and the tip of
the needle are positioned in the trachea” because the Okada device “has
nothing to do with the neck or the trachea of a patient” (id. at 14).
We do not find this argument to be persuasive. The limitation relating
to the position of the second portion of the dilator is addressed above in
relation to claim 32. The fact that Okada’s device is intended for use with a
catheter is relevant only to the issue of whether it would have been obvious
to combine its features with those of Sauer’s device; the device suggested by
the combined references would have been useful in performing a
tracheostomy.
Finally, Appellant argues that “the method of claim 19 also requires
the length of the first portion be at least as long as the taper of the second
portion, and the second portion of the dilator be located outside the neck of
the patient when the tip of the needle and the forward end of the first portion
are positioned in the trachea” (Appeal Br. 14). Appellant concludes that
claim 19 is nonobvious based on the “same arguments made above with
respect to claim 18” (id.).
These arguments are not persuasive for the reasons discussed above
with respect to claims 18 and 32.
We affirm the rejection of claims 18 and 19 as obvious in view of
Sauer and Okada. Claims 3-8, 11, 20-27, and 34 fall with claim 18 because
they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
The Examiner’s rejections are supported by the preponderance of the
evidence of record. We therefore affirm the rejection of claim 32 under
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35 U.S.C. § 102 and the rejection of claims 3-8, 11, 18-27, and 34 under
35 U.S.C. § 103.
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

dm

Louis Woo
Law Office of Louis Woo
717 North Fayette Street
Alexandria, VA 22314
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