Ex Parte Rutter

Patent Trial and Appeal Board

Jun 10, 2013

11683173 (P.T.A.B. Jun. 10, 2013)

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.
11/683,173 03/07/2007 Michael John Rutter RUT-003 1394
26868 7590 06/11/2013
Hasse & Nesbitt LLC
8837 Chapel Square Drive
Suite C
CINCINNATI, OH 45249
EXAMINER
DIXON, ANNETTE FREDRICKA
ART UNIT PAPER NUMBER
3778
MAIL DATE DELIVERY MODE
06/11/2013 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 MICHAEL JOHN RUTTER
__________

Appeal 2012-000891
Application 11/683,173
Technology Center 3700
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal
1
under 35 U.S.C. § 134 involves claims 1-5, 10-15, 17,
and 19, which the Examiner rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part.
STATEMENT OF THE CASE
Claims 1, 10, and 14, the independent claims, illustrate the appealed
subject matter and read as follows (emphasis added):

1
The Real Party in Interest is the inventor, Michael John Rutter (App. Br.
3).
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Application 11/683,173

2
1. A tracheostomy tube comprising:
a rigid proximal section adapted to connect to a
mechanical ventilation device;
a flexible intermediate section being bendable along its
length and insertable below the vocal cords in the trachea; and
a rigid distal section including a beveled distal tip
adapted to prevent occlusion of the distal section by the tracheal
walls,
wherein the flexible intermediate section does not
elongate or contract in the axial direction, and bends in
response to outside pressure exerted during swallowing or
coughing to allow the rigid distal section of the tube to move
within the trachea and remain in a parallel orientation relative to
the tracheal lumen, and wherein the beveled distal tip includes
an anterior aspect and a posterior aspect, the anterior aspect
being shorter in length than the posterior aspect.

10. A tracheostomy tube comprising:
a rigid proximal section adapted to connect to a
mechanical ventilation device;
a flexible intermediate section being bendable along its
length, insertable below the vocal cords in the trachea, and
comprising a smooth surface; and
a rigid distal section,
wherein the flexible intermediate section does not
elongate or contract in the axial direction, and bends in
response to outside pressure exerted during swallowing or
coughing to allow the rigid distal section of the tube to move
within the trachea and remain in a parallel orientation relative to
the tracheal lumen, and wherein the proximal section, the
intermediate section and the distal section are each sufficiently
rigid to resist collapse in the radial direction.

14. A tracheostomy tube comprising:
a beveled distal tip adapted to prevent distal occlusion of
the tube by the tracheal walls, the beveled distal tip including
an anterior aspect and a posterior aspect, the anterior aspect
being shorter in length than the posterior aspect, wherein the
Appeal 2012-000891
Application 11/683,173

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posterior aspect of the distal tip includes a rounded, beaded
edge to minimize the risk of damage to the tracheal walls and to
provide a guide indicating the end of the tube during suctioning.

The following rejections are before us for review:
(1) Claims 1, 2, 4, 5, and 10-12, under 35 U.S.C. § 103(a) as obvious
over Heimlich
2
and Virag
3
(Ans. 4-8); and
(2) Claims 3, 13-15, 17, and 19, under 35 U.S.C. § 103(a) as obvious
over Heimlich, Virag, and Goebel
4
(Ans. 8-9).
OBVIOUSNESS – HEIMLICH AND VIRAG
The Examiner cited Heimlich as describing a tracheostomy tube
substantially as claimed, but conceded that Heimlich‟s tube differed from the
tube recited claims 1 and 10 in that the reference did not “expressly disclose
the functionality of the flexible intermediate section to „not elongate or
contract in the axial direction‟ nor the structure of the „beveled distal tip‟ on
the rigid distal section as claimed” (Ans. 5).
To address those deficiencies, the Examiner cited Virag as describing
a tracheal tube with a flexible intermediate section that did not elongate or
contract in the axial direction, as well as a beveled tip (id. at 5-6).
Based on the references‟ teachings, the Examiner reasoned that an
ordinary artisan would have considered it obvious to “modify the tube of
Heimlich to have a flexible intermediate section being bendable along its
length and a beveled distal tip as taught by Virag, as doing so would enhance

2
U.S. Patent No. 4,987,895 (issued Jan. 29, 1991).
3
U.S. Patent No. 5,546,936 (issued Aug. 20, 1996).
4
U.S. Patent No. 7,601,138 B2 (filed Jun. 18, 2002).
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tube accommodation of trachea movement and increase safety during tube
insertion into a patient‟s trachea” (id. at 6).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . 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.

In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, the Court also reaffirmed the importance of
determining “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418.
Thus, even post-KSR, “[o]bviousness requires more than a mere
showing that the prior art includes separate references covering each
separate limitation in a claim under examination.” Unigene Laboratories,
Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011).
Instead, “[i]n determining whether obviousness is established by
combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
In this instance, we agree with Appellant that the cited references
would not have suggested, to an ordinary artisan, a tracheostomy tube
having a flexible intermediate section that does not elongate or contract in
the axial direction, as required in both claims 1 and 10.
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The claimed tracheostomy tube, and the tracheostomy tube described
in Heimlich, are inserted through an opening in the anterior neck, allowing a
patient to breathe through that opening (see Spec. [0004]; see also
Appellant‟s Fig. 2; Heimlich, col. 1, ll. 22-31, and Figs. 1 and 2). In
contrast, Virag describes a tracheal tube inserted through either the mouth or
nose for administering inhaled anesthetic (see Virag, col. 1, ll. 11-63).
We acknowledge Virag‟s disclosure that placing a flexible
intermediate section between two relatively rigid sections of its tracheal tube
is advantageous in that the proximal section of the tube outside the patient
can be easily moved during surgery, without the need for re-intubation, thus
reducing the risk of trauma to the patient‟s nose, mouth, and trachea (see id.
at col. 5, ll. 28-42).
The essential thrust of Heimlich‟s disclosure, however, is that the
central portion of its tracheostomy tube is made of a collapsible material that
allows for “free axial movement” of that section of the tube (Heimlich, col.
4, l. 26). Because the axial dimension of the central section of the tube
changes to accommodate swallowing and other tracheal movements, the
rigid distal portion of the tube does not move in relation to the trachea, thus
avoiding abrasion and scar tissue formation (see id. at col. 3, ll. 50-66).
Thus, replacing the collapsible central portion of Heimlich‟s tube with
a tube such as Virag‟s, that does not contract or elongate axially as required
by claims 1 and 10, would eliminate the central inventive feature of
Heimlich‟s device that allows it to avoid undesired tracheal abrasion. We
are therefore not persuaded that Virag would have prompted an ordinary
artisan to modify Heimlich in the manner posited by the Examiner.
Moreover, the Examiner directs us to no teaching in either reference, or in
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the knowledge generally available to an ordinary artisan, suggesting that the
flexible intermediate portion of Virag‟s device would function equivalently
to the axially movable collapsible central portion of Heimlich‟s tube,
particularly given that Virag‟s device does not contract or elongate in the
axial direction as required of Heimlich‟s device.
We are therefore not persuaded that the Examiner has adequately
explained why the cited references would have prompted an ordinary artisan
to modify the central portion Heimlich‟s tube so that it did not elongate or
contract axially, as required by claims 1 and 10. Accordingly, we reverse
the Examiner‟s obviousness rejection of those claims, and their dependent
claims 2, 4, 5, 11, and 12, over Heimlich and Virag.
OBVIOUSNESS –
HEIMLICH, VIRAG, AND GOEBEL
In rejecting claims 3, 13-15, 17, and 19 obvious over Heimlich, Virag,
and Goebel, the Examiner relied on the teachings of Heimlich and Virag as
discussed above, and cited Goebel as evidence that an ordinary artisan
would have considered it obvious to provide Heimlich‟s device, when
modified to have a beveled distal tip, to also have “a rounded, beaded edge
as taught by Goebel in order to help reduce the risk of trauma to a patient's
airway” (Ans. 9).
Claims 3 and 13 depend directly or ultimately from claims 1 and 10,
and therefore include the requirement in claims 1 and 10 of a flexible
intermediate section that does not elongate or contract in the axial direction.
As the Examiner does not point to any teaching in Goebel that remedies the
shortcomings, discussed above, of Heimlich and Virag as to that limitation
of claims 1 and 10, we reverse the Examiner‟s rejection of claims 3 and 13.
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Claim 14 does not include the requirement of a flexible intermediate
section that does not elongate or contract in the axial direction. Claim 17,
however, which depends from claim 14, does include that feature (see App.
Br. 23). We therefore also reverse the Examiner‟s rejection of claim 17, as
well as its dependent claims 15 and 19.
As to claim 14, however, Appellant‟s arguments do not persuade us
that the preponderance of the evidence fails to support the Examiner‟s prima
facie case.
Claim 14 does not require the recited tracheostomy tube to have an
intermediate section that does not elongate or contract in the axial section.
Rather, claim 14 only requires the tracheostomy tube to have a beveled distal
tip with the anterior aspect being shorter in length than the posterior aspect,
and also to have a rounded, beaded edge to minimize the risk of damage to
the tracheal walls and to provide a guide indicating the end of the tube
during suctioning.
In view of Virag‟s disclosure of the suitability of a beveled distal tip
for the intra-tracheal end of its tracheal tube (see Virag, col. 5, ll. 4-8),
Appellant‟s arguments do not persuade us that the Examiner erred in finding
that an ordinary artisan would have been prompted to provide Heimlich‟s
tube with such a beveled end, and to optimize the orientation and size of the
bevel so as to supply adequate airflow without compromising the tube‟s
structural rigidity (see Ans. 7).
We acknowledge that Goebel is directed to a catheter for insertion
into the epidural space (see Goebel, col. 2, ll. 13-20) or a vein (see id. at col.
3, ll. 28-38) rather than a tracheostomy tube. As the Supreme Court has
explained, however, “the [obviousness] analysis need not seek out precise
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teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR, 550 U.S. at 418. Thus, a
“person of ordinary skill is . . . a person of ordinary creativity, not an
automaton.” Id. at 421.
We discern no error in the Examiner‟s finding that an ordinary artisan
would have reasonably inferred that providing a rounded tip like that
described by Goebel (see Goebel, col. 3, ll. 1-13; see also id. at Fig. 1) to
any device inserted into the lumen of a patient, including a tracheostomy
tube, would advantageously avoid damage caused by excessively sharp
edges. We therefore affirm the Examiner‟s rejection of claim 14 as obvious
over Heimlich, Virag, and Goebel.
SUMMARY
We reverse the Examiner‟s obviousness rejection of claims 1, 2, 4, 5,
and 10-12 over Heimlich and Virag.
We also reverse the Examiner‟s obviousness rejection of claims 3, 13,
15, 17, and 19 over Heimlich, Virag, and Goebel.
However, we affirm the Examiner‟s obviousness rejection of claim 14
over Heimlich, Virag, and Goebel.

TIME PERIOD
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
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