Ex Parte Lyons et al

Patent Trial and Appeal Board

Sep 27, 2012

11799135 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
11/799,135 05/01/2007 Drew P. Lyons 10703/106
(PA-6159-RFB)
5637
48004 7590 09/27/2012
BRINKS HOFER GILSON & LIONE/INDY/COOK
BRINKS HOFER GILSON & LIONE
CAPITAL CENTER, SUITE 1100
201 NORTH ILLINOIS STREET
INDIANAPOLIS, IN 46204-4220
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
09/27/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DREW P. LYONS and ANDREW K. HOFFA
__________

Appeal 2011-012015
Application 11/799,135
Technology Center 3700
__________

Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a loading
dilator for positioning a tracheostomy tube. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-
in-part.

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Statement of the Case
Background
The Specification teaches that it “would be desirable to provide a
loading dilator that is sized to accommodate tracheostomy tubes having a
range of diameters, and that is structured to minimize the transition between
the loading dilator and the tracheostomy tube upon insertion of a
dilator/tracheostomy tube apparatus” (Spec. 3 ¶ 0008).
The Claims
Claims 1, 3-6, and 9-21 are on appeal. We will focus on claims 1, 10,
and 17, which are representative and read as follows:
1. A loading dilator for positioning a tracheostomy tube
across a stoma formed through the tracheal wall of a patient,
wherein the tracheostomy tube is sized to fit over a portion
of the loading dilator during positioning of the tracheostomy
tube across the stoma, the loading dilator comprising:
an elongated dilator body having a proximal end and a
distal end, said distal end being tapered in a manner to
facilitate axial entry into said stoma, said dilator body
having a curve along a distal portion thereof and having an
inflatable balloon disposed over at least a portion of said
curve, said balloon being inflatable to a configuration such
that a distal end of said balloon defines a distal taper
between said elongated dilator body and a leading end of
said tracheostomy tube when said tracheostomy tube is fit
over said loading dilator, said balloon distal taper
comprising a substantially non-traumatic axial leading end
into said stoma.

10. An assembly for establishing a ventilation
passageway through the tracheal wall of a patient, said
assembly comprising a loading dilator and a tracheostomy
tube carried on an outer surface of the loading dilator; the
loading dilator comprising an elongated dilator body having
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a proximal end and a distal end, at least a portion of said
distal end being tapered for facilitating entry through a
stoma in said tracheal wall, said dilator body having an
inflatable balloon disposed along an outer surface of said
distal end, said balloon being inflatable to a diameter such
that a generally smooth distal taper is formed between said
elongated dilator body and a leading end of said
tracheostomy tube when said tracheostomy tube is carried
on said dilator.

17. A method for positioning a tracheostomy tube across
a stoma formed in the tracheal wall of a patient, comprising:
providing a loading dilator for carrying the
tracheostomy tube, the loading dilator comprising an
elongated dilator body having a distal end, a distal tip of said
distal end being tapered for facilitating entry into said stoma,
said dilator body having a curve along a distal portion
thereof and having an inflatable balloon disposed along said
curved distal portion, said inflatable balloon having a
proximal end and a distal end, and being inflatable to a
diameter such that a distal taper may be formed between the
elongated dilator body and a leading end of the
tracheostomy tube when the tracheostomy tube is fit over the
loading dilator;
loading the tracheostomy tube onto the loading
dilator, and positioning the tracheostomy tube thereon such
that a portion of the balloon distal end extends distally
beyond a leading end of the tracheostomy tube;
inflating the balloon such that the extending balloon
distal end portion provides a distally-directed taper between
an outer diameter of the loading dilator and the
tracheostomy tube leading end;
inserting the distal end of the elongated dilator body
across the stoma formed in the tracheal wall; and
axially advancing the loading dilator and
tracheostomy tube leading end through the stoma, with the
balloon in the inflated condition, such that a portion of the
tracheostomy tube lies across the stoma.
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The issues
A. The Examiner rejected claims 1, 3, 4, and 9 under 35 U.S.C. § 102(b)
as anticipated by Fischer, Jr.1 (Ans. 3-4).
B. The Examiner rejected claims 1, 3, 9, 10, 12-14, and 17-21 under 35
U.S.C. § 103(a) as being obvious over Sauer2 and Fischer, Jr. (Ans. 4-6).
C. The Examiner rejected claims 5, 6, 15, and 16 under 35 U.S.C.
§ 103(a) as being obvious over Sauer, Fischer, and Freitag3 (Ans. 6).
A. U.S.C. § 102(b) over Fischer, Jr.
The Examiner finds that “Fischer discloses a loading dilator (16) that
is disposed within a tracheostomy tube (20), as shown in Figure 1” (Ans. 3).
The Examiner finds that the “the dilator (16) includes an inflatable balloon
(18) that is tapered and curved for atraumatic entry into the trachea” (Ans.
3). The Examiner finds that the “balloon is made of wire reinforced
polyurethane (par 30-38), which meets the broad limitation ‘semi-
compliant.’” (Ans. 3).
Appellants contend that “[i]t is important to recognize that loading
dilator 12 is a different dilating element than the inflatable balloon dilator.
Loading dilator 12 carries the tracheal tube, and provides a smooth
transitional taper for insertion of the tracheal tube 20 through the opening
that had been previously dilated by the balloon.” (App. Br. 8).
Appellants contend that “it is clear that the element 16 of Fischer
identified by the Examiner is not a loading dilator of a type that is capable of

1 Fischer, Jr., US 2005/0183729 A1, published Aug. 25, 2005.
2 Sauer, J., US 6,109,264, issued Aug. 29, 2000.
3 Freitag, L., US 5,803,080, issued Sep. 8, 1998.
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carrying a tracheostomy tube. Rather, it is a catheter having a balloon at its
distal end positioned and configured in a manner to radially dilate the
ostomy in the tracheal wall” (App. Br. 8). Appellants contend that “the
actual loading dilator in Fischer is not element 16 identified by the Examiner
as meeting the claim limitation, but rather, is hollow dilator 12 having
tapered end 14” (App. Br. 9).
Appellants contend that “[a]t best, Fischer teaches an inflatable radial
dilator that may be utilized to dilate a stoma that may later be penetrated by
an assembly comprising a loading dilator and a tracheostomy tube. No
teaching or suggestion of providing a tapered inflatable balloon as the
loading dilator is found in the citation.” (App. Br. 10).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Fischer anticipates claim 1?
Findings of Fact
1. Figure 1 of Fischer is reproduced below:

“FIG. 1 illustrates a preferred embodiment of a percutaneous dilational
device 10 for forming an ostomy in a tracheal wall” (Fischer 2 ¶ 0025).
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2. Fischer teaches “to provide an atraumatic dilation device for
forming an ostomy in a tracheal wall that substantially avoids damage to the
tracheal wall and permits the enlargement of a formed ostomy without risk
of perforating the rear of the trachea” (Fischer 1 ¶ 0012).
3. Fischer teaches that the “device 10 comprises a hollow dilator
tube 12 having a tapered distal end 14, and a reinforced balloon catheter 16
coaxially carried by and disposed within a throughbore of the dilator tube
12” (Fischer 2 ¶ 0025).
4. Fischer teaches that “[b]alloon catheter 16 comprises a shaft
portion 17, an inflatable balloon portion 18, and a distal tip portion 19.
Preferably, distal tip 19 comprises an atraumatic tip” (Fischer 2 ¶ 0026).
5. Fischer teaches that the “balloon preferably has a generally
cylindrical shape upon inflation, and includes tapered proximal end 39 and
distal end 41” (Fischer 2 ¶ 0027).
6. Fischer teaches that the
diameter of the dilator tube 12 and the diameter of the
balloon 18 when inflated are selected to match the size of
the tracheal tube 20 being inserted. . . .it may be
advantageous to apply a water-soluble jelly or other
lubricant over the dilator tube 12 to ensure that the tracheal
tube 20 does not become stuck on the dilator tube 12

(Fischer 4 ¶ 0046).
7. Fischer teaches that:
It is also preferable that the balloon 18, when inflated, have
a diameter equal to or slightly greater than the outside
diameter of the tracheal tube 20 and uninflated cuff 24. . . .
This close sizing or slight oversizing of the balloon diameter
as compared to the tracheal tube diameter ensures that the
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ostomy formed by the balloon 18 will be large enough to
prevent damage to the uninflated cuff 24 during insertion of
the tracheal tube 20 into the ostomy.

(Fischer 4 ¶ 0047).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
A preamble is not limiting “‘where a patentee defines a structurally
complete invention in the claim body and uses the preamble only to state a
purpose or intended use for the invention.”’ Catalina Mktg. Int’l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
Analysis
Fischer teaches a “device 10 [which] comprises a hollow dilator tube
12 having a tapered distal end 14, and a reinforced balloon catheter 16
coaxially carried by and disposed within a throughbore of the dilator tube
12” (Fischer 2 ¶ 0025; FF 3). Fischer discloses that the dilator body is
curved in Figure 1 (FF 1) and teaches that “[b]alloon catheter 16 comprises a
shaft portion 17, an inflatable balloon portion 18, and a distal tip portion 19.
Preferably, distal tip 19 comprises an atraumatic tip” (Fischer 2 ¶ 0026; FF
4). Fischer teaches that the “balloon preferably has a generally cylindrical
shape upon inflation, and includes tapered proximal end 39 and distal end
41” (Fischer 2 ¶ 0027; FF 5).
We agree with the Examiner that Fischer teaches all of the structural
limitations of the claim (see Ans. 3-4). Claim 1 defines a structurally
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complete invention consistent with Catalina. The preamble is used only to
state the intended use of the invention.
Appellants contend that “[i]t is important to recognize that loading
dilator 12 is a different dilating element than the inflatable balloon dilator.
Loading dilator 12 carries the tracheal tube, and provides a smooth
transitional taper for insertion of the tracheal tube 20 through the opening
that had been previously dilated by the balloon.” (App. Br. 8).
While we appreciate that dilator 12 differs from catheter 16, both
dilator 12 and catheter 16 reasonably satisfy the structural requirements of
claim 1 as discussed above. Both components have distal tapers, curves and
an inflatable balloon 18 disposed over the curved portion of the components,
and atraumatic ends, which comprise the structural requirements of claim 1
(FF 1-7).
Appellants contend that “it is clear that the element 16 of Fischer
identified by the Examiner is not a loading dilator of a type that is capable of
carrying a tracheostomy tube. Rather, it is a catheter having a balloon at its
distal end positioned and configured in a manner to radially dilate the
ostomy in the tracheal wall” (App. Br. 8). Appellants contend that “the
actual loading dilator in Fischer is not element 16 identified by the Examiner
as meeting the claim limitation, but rather, is hollow dilator 12 having
tapered end 14” (App. Br. 9).
We are not persuaded. Appellants are essentially focusing on the
name used for the device, rather than the structure depicted in Fischer.
Appellants do not identify any element of claim 1 which catheter 16 fails to
satisfy.
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Appellants contend that “[a]t best, Fischer teaches an inflatable radial
dilator that may be utilized to dilate a stoma that may later be penetrated by
an assembly comprising a loading dilator and a tracheostomy tube. No
teaching or suggestion of providing a tapered inflatable balloon as the
loading dilator is found in the citation.” (App. Br. 10).
We are not persuaded. Since the use of the tapered inflatable balloon
as a loading dilator is solely an intended use of the claimed device, we agree
with the Examiner that either dilator 12 or the catheter 16 satisfy the actual
structural requirements of the claim. It must be the structure and not simply
the mode of operation or intended use which differentiates a product claim.
See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (“It is well settled
that the recitation of a new intended use for an old product does not make a
claim to that old product patentable.”)
Conclusions of Law
The evidence of record supports the Examiner’s conclusion that
Fischer anticipates claim 1.
B. U.S.C. § 103(a) over Sauer and Fischer, Jr.
The Examiner finds that “Sauer discloses an assembly comprising a
loading dilator (30) and a tracheostomy tube (26) carried on an outer surface
of the dilator (Figure 1). The dilator includes an elongated body portion (15)
and an inflatable balloon (30) on the outer surface of distal balloon mount
(200)” (Ans. 4). The Examiner finds that “Sauer fails to disclose that the
dilator is curved near the balloon and that the distal end of the balloon is
tapered” (Ans. 4). The Examiner finds that “Fischer teaches that the balloon
should have a curved and distally tapered profile, as best illustrated in figure
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4, to reduce trauma to the trachea wall during formation of the stoma” (Ans.
4-5).
The Examiner finds it obvious to “provide the curved and distally
tapered balloon of Fischer with the tracheostomy assembly of Sauer in order
to reduce the trauma to the tracheal wall during formation of the stoma”
(Ans. 5).
Appellants contend that Sauer’s “dilator 30 is structured . . . to
radially dilate the opening” (App. Br. 11). Appellants contend that Sauer’s
“device is structured in a manner to enable it to carry out its dilation in a
much different way than the claimed device, which is structured in a manner
that enables it to carry out an axial, or longitudinal, dilation (i.e., push
dilation) through the tracheal wall” (App. Br. 11).
Appellants contend that “Sauer teaches away from axial dilation
techniques. According to Sauer, his dilation apparatus for accomplishing
radial dilation ‘is in strong contrast’ (Col. 11, line 32) to conventional
dilators that utilize inward (e.g., axial, or push) dilating pressure” (App. Br.
11).
Appellants contend that “[n]either reference teaches or suggests the
insertion and axial advancement of a loading dilator (comprising an inflated
balloon) and tracheostomy tube as claimed” (App. Br. 16).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the combination of Sauer and
Fischer render the claims obvious?

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Findings of Fact
8. Sauer teaches an “apparatus which is useful in performing a
wide variety of medical procedures such as percutaneous tracheostomy”
(Sauer, col. 2, ll. 63-65).
9. Figure 1 of Sauer is reproduced below:

“FIG. 1 is a perspective view of the apparatus” (Sauer, col. 4, l. 57).
10. Sauer teaches that the apparatus includes “tracheostomy tube
26, inflatable tube segment or cuff 28 and inflatable dilator 30” (Sauer, col.
6, ll. 29-30).
11. Figure 31 of Sauer is reproduced below:

“FIG. 31 shows a cross-sectional side view of the inflatable distal end of the
device” (Sauer, col. 5, ll. 50-51).
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12. Sauer teaches that “[i]nflatable dilator 30 is clamped at one end
by dilator tip 68 and at a second end by crimp ring mounting mechanism 60
onto balloon mount 200.” (Sauer, col. 6, ll. 57-60).
13. Sauer teaches that “inward force causes the dilator tip to pass
through the tracheal wall into the lumen. Next, the smaller diameter sleeve
166 covered with the tightly folded down inflatable dilator 30 slides through
the hole in the tracheal wall and into the lumen” (Sauer, col. 9, ll. 40-44).
14. Sauer teaches that
the dilator tip 68 is advanced through the tracheal wall such
that a substantial portion of the inflatable dilator 30 is
disposed in the tracheal wall. . . . Once the inflatable dilator
30 is inserted into the tracheal wall, the surgeon depresses
trigger 22 in the direction indicated by the directional arrow
to selectively inflate inflatable dilator 30 . . . As the
expandable dilator 30 inflates, the adjacent tracheal rings are
displaced from each other

(Sauer, col. 11, ll. 10-22).
15. Sauer teaches that “after inflating the inflatable dilator 30 and
creating the passageway through the tracheal wall, the surgical device is
further inserted down the tracheal lumen” (Sauer, col. 12, ll. 3-6).
16. Sauer teaches that “the expandable dilator is employed to
provide an enlarged opening between the adjacent tracheal rings to permit
insertion of a tracheostomy tube” (Sauer, col. 12, ll. 58-61).
Principles of Law
“Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
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with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Claim 10
Sauer teaches an apparatus for performing tracheostomy (FF 8) which
comprises a tracheostomy tube 26 carried on the outer surface of an
inflatable dilator 30 (FF 9-10). Sauer teaches that the distal end dilator tip
68 is tapered (FF 11) and comprises an inflatable balloon 30 (FF 12-14).
The Examiner acknowledges that Sauer does not teach that the distal
end of the balloon is tapered (Ans. 4), but relies upon Fischer’s teaching that
the “balloon preferably has a generally cylindrical shape upon inflation, and
includes tapered proximal end 39 and distal end 41” (Fischer 2 ¶ 0027; FF
5).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that an ordinary artisan would have reasonably found it obvious to
incorporate the balloon tapering of Fischer into the dilator balloon of Sauer
since Fischer teaches that “close sizing or slight oversizing of the balloon
diameter as compared to the tracheal tube diameter ensures that the ostomy
formed by the balloon 18 will be large enough to prevent damage to the
uninflated cuff 24 during insertion of the tracheal tube 20 into the ostomy”
(Fischer 4 ¶ 0047; FF 7). This is consistent with the Examiner’s finding “to
provide the curved and distally tapered balloon of Fischer with the
tracheostomy assembly of Sauer in order to reduce the trauma to the tracheal
wall during formation of the stoma” (Ans. 5). Such a combination is merely
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a “predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellants contend that “[n]either Sauer nor Fischer teaches or
suggests a device that has the very specific structure identified above. Also,
neither citation teaches or suggests a device capable of being push dilated in
this manner to facilitate insertion of the tracheostomy tube” (App. Br. 12).
Appellants contend that “Sauer teaches away from axial dilation techniques.
According to Sauer, his dilation apparatus for accomplishing radial dilation
‘is in strong contrast’ (Col. 11, line 32) to conventional dilators that utilize
inward (e.g., axial, or push) dilating pressure” (App. Br. 11).
We are not persuaded. It is the combination of Sauer and Fischer
which renders the claimed device obvious. The Examiner provides specific
reasoning to modify Sauer based on Fischer to achieve the claimed device,
and we agree that this reasoning is sufficient to support a prima facie case of
obviousness (Ans. 3-5). With regard to Appellants functional argument that
neither citation teaches the device may be “push dilated”, this is not a
limitation of the product claim, nor does this intended use impose any
specific structural limitations which distinguish claim 10 from the prior art.
Schreiber, 128 F.3d at 1477.
We also do not find the teaching away argument persuasive. A
teaching away requires a reference to actually criticize, discredit, or
otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one
alternative does not constitute a teaching away from any of these alternatives
because such disclosure does not criticize, discredit, or otherwise discourage
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the solution claimed”). Appellants do not identify, and we do not find, any
teaching in the cited references which criticize, discredit, or otherwise
discourage the claimed combination.
Claim 17
The Examiner finds that the “claim steps are written broadly enough
to encompass the act of expanding the dilator balloon while it is positioned
in the tissue, as the subsequent act of moving the assembly meets the
requirement of inserting the distal end of the elongated dilator body across
the stoma formed in the tracheal wall” (Ans. 6).
Appellants contend that “[n]either reference teaches or suggests the
insertion and axial advancement of a loading dilator (comprising an inflated
balloon) and tracheostomy tube as claimed” (App. Br. 16).
We find that Appellants have the better position. As noted above, the
Specification discloses that it “would be desirable to provide a loading
dilator that is sized to accommodate tracheostomy tubes having a range of
diameters, and that is structured to minimize the transition between the
loading dilator and the tracheostomy tube upon insertion of a
dilator/tracheostomy tube apparatus” (Spec. ¶ 0008 (emphasis added)). To
address these issues, the Specification discloses:
The balloon is inflated such that the extending balloon distal
end portion provides a generally smooth diametrical transition
between an outer diameter of the loading dilator and the
medical apparatus leading end. The distal end of the elongated
dilator body is inserted into the stoma, and the loading dilator
and medical apparatus are advanced such that a portion of the
medical apparatus lies across the stoma.
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(Id. at ¶ 0011.) Based on the description of the method in the Specification,
we interpret claim 17 to specifically require the step of “inflating the
balloon” prior to the step of “inserting the distal end,” which is followed by
a step of “axially advancing the loaded dilator”.
The Examiner does not identify, and we do not find, teachings in
either Sauer or Fischer which suggest first inflating the balloon and then
inserting the dilator into the stoma. Sauer teaches that:
Once the inflatable dilator 30 is inserted into the tracheal
wall, the surgeon depresses trigger 22 in the direction
indicated by the directional arrow to selectively inflate
inflatable dilator 30 . . . As the expandable dilator 30
inflates, the adjacent tracheal rings are displaced from each
other

(Sauer, col. 11, ll. 10-22; FF 14). As also shown in Figures 28-32, Sauer
first inserts the dilator into the stoma and then inflates the balloon, rather
than inflating the balloon first and then inserting the dilator. The Examiner
provides no reason or evidence to alter the order of steps shown in Sauer.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Sauer and Fischer renders claim 10 obvious.
The evidence of record does not support the Examiner’s conclusion
that the combination of Sauer and Fischer renders claim 17 obvious.
C. U.S.C. § 103(a) over Sauer, Fischer, Jr., and Freitag
The Examiner finds it obvious to “one of ordinary skill in the art at the
time the invention was made to provide the inflation lumen on the outside of
the dilator of the modified Sauer device, as taught by Freitag, as this is
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simply an alternate way to provide a balloon inflation lumen of a dilator
used in tracheal procedures” (Ans. 6).
Having already affirmed the base rejection Sauer and Fischer, Jr., we
also agree with the Examiner that substantial evidence supports the
Examiner’s combination of Freitag with Sauer and Fischer, Jr.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 102(b) as being anticipated by Fischer, Jr.. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 3, 4, and 9 as
these claims were not argued separately.
We affirm the rejection of claims 1 and 10 under 35 U.S.C. § 103(a)
as being obvious over Sauer and Fischer, Jr. Pursuant to 37 C.F.R.
§ 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 3, 9, and 12-
14 as these claims were not argued separately.
We reverse the rejection of claims 17-21 under 35 U.S.C. § 103(a) as
being obvious over Sauer and Fischer, Jr.
We affirm the rejection of claims 5, 6, 15, and 16 under 35 U.S.C.
§ 103(a) as being obvious over Sauer, Fischer, and Freitag.

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-IN-PART
lp