Ex Parte Woo

Board of Patent Appeals and Interferences

Oct 31, 2011

10685809 (B.P.A.I. Oct. 31, 2011)

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.
10/685,809 10/16/2003 Louis Woo 0119/0017 5136
21395 7590 10/31/2011
LOUIS WOO
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
ANDERSON, MICHAEL J
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
10/31/2011 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 LOUIS WOO
____________________

Appeal 2010-002947
Application 10/685,809
Technology Center 3700
____________________

Before, FRED E. McKELVEY, ROBERT A. CLARKE, and
JONI Y. CHANG, Administrative Patent Judges.

CLARKE, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2010-002947
Application 10/685,809

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A. Statement of the case

Smiths Group plc [hereinafter Smiths], the real party in interest, seeks
review under 35 U.S.C. § 134(a) of a rejection (mailed February 24, 2009).
The application was filed on October 16, 2003. The application
claims benefit under 35 U.S.C. § 119(e) of prior provisional application
60/422,480 (filed October 31, 2002).
Claims 1-12 are on appeal.
The following prior art has been cited by the Examiner:
Kuhn U.S. Patent 3,363,629 6 Aug. 1964
Ciaglia U.S. Patent Publication
2002/0066453 A1
6 Jun. 2002

Kuhn is prior art under U.S.C. §102(b).
Ciaglia is prior art under 35 U.S.C. § 102(e). Smiths does not contest
in the appeal the prior art status of Ciaglia.
Additionally, we cite the following prior art reference.
Buckley WO 92/14,396 3 Sept. 1992

Buckley is prior art under 35 U.S.C. §102(b)
We have jurisdiction under 35 U.S.C. 134(a).

B. Findings of Fact
The following findings of fact are supported by a preponderance of
the evidence.
Field of the invention
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The Smiths invention relates to dilators used in forming a
percutaneous tracheostomy. (Spec. 1)1

Background of the invention
Percutaneous tracheostomies can be formed by using a series of
dilators having increasing diameters so that the opening is gradually
expanded, or alternatively using a single steeply tapered dilator. (Spec. 1)

Description of the invention
The Smiths invention is to provide dilators that are curved in one
direction at a patient end region and in the opposite sense at the opposite
end. The dilator is also disclosed and claimed as smoothly curved along
substantially its entire length with an “S” shape. (Spec. 2)
The curved shape of the dilator handle is described as overcoming the
problem of how to apply a relatively high insertion force in a controlled
manner with the thumb and forefinger providing guidance and the other
three fingers providing the force. (Spec. 5)

Claims on appeal
Independent Claim 1, which we reproduce from the Claim Appendix
of the Appeal Brief, reads [bracketed matter and some indentations added;
limitations in issue in the appeal are italicized]:
1. A tracheostomy dilator comprising:

1 All references to Spec. are to Appellant’s Specification filed October 16,
2003.
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[1] a patient end region, said patient end region being curved,
tapered and
adapted for insertion through a tracheostomy to expand
the tracheostomy as it is inserted; and
[2] a handle region at an end of the dilator opposite said patient
end region,
wherein said handle region is curved in an opposite sense
from said patient end region.
Independent Claims 11 and 12 require that the dilator is smoothly
curved along substantially its entire length with an S shape.

Examiner’s rejection
In the Examiner’s Answer the Examiner maintained the rejection of
Claims 1-12 under 35 U.S.C. § 103(a) as being unpatentable over Ciaglia
and Kuhn. (Ans. 3)2

Prior Art
(1) Ciaglia
Ciaglia describes a dilator (10) having a shaft portion (12), a curved,
tapered distal portion (16) extending from one end of the shaft portion and
an opposite proximal end (14) extending from the opposite end of the shaft.
(¶ 0016) The shaft is described as generally linear. (¶ 0006)
Fig. 2 of Ciaglia, reproduced below, illustrates a dilator as described
in Ciaglia.

2 All references to Ans. are to the Answer dated September 16, 2009.

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Ciaglia describes a dilator positioned on a guidewire that extends
through an incision of a patient and in the tracheal entrance between two
adjacent tracheal rings. The dilator is inserted over the guidewire into the
patient. (¶ 0022)
Fig. 4 of Ciaglia, reproduced below, illustrates a dilator used as
described in Ciaglia.

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The Examiner also found that Ciaglia made provision of a curved
handle. (Ans. 3)
(2) Kuhn
Kuhn, describes an endotracheal catheter for anesthetic
administration. (Col. 1, ll. 11-12)
The catheter is described as being “S” shaped. Beginning from the
end disposed in use away from the patient the catheter has a first straight
section followed by a first curved part; this being followed by a straight
section and after this a second curved section that is curved oppositely to the
first curved section. (Col. 1, ll. 35-44)
The figure of Kuhn, reproduced below, illustrates a catheter as
described in Kuhn.

Kuhn describes that in use the first curved section is conforming to the
curvature in the region of the patient’s pharynx and trachea and that second
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curved section is conforming to the curvature of the root of the patients
tongue in the hypopharynx. (Claim 1)
The Examiner found that it has been held that a change in shape of a
prior art device is a design consideration within the skill in the art. (Ans. 8,
9)
The Examiner concluded that one of ordinary skill in the art at the
time the invention was made would have modified the dilator of Ciaglia as
shown in Kuhn for easy insertion without damage to the vocal cavity and the
trachea. (Ans. 6)

Appellant’s Arguments
In response to the Examiner’s finding that Ciaglia makes provisions
for a curved handle, Smiths argues that the Ciaglia describes a generally
linear shaft. (App. Br. 3 10-11; Rep. Br. 4 1-2)
Smiths argues that the Examiner’s reliance on the teaching of Kuhn to
avoid damage to the vocal cavity and trachea by shaping a catheter in an “S”
shape is misplaced because the vocal cavity is damaged when an opening is
surgically made in the neck tissue and tracheal cartilages of a patient when a
tracheostomy dilator is used to expand the opening such as described in
Ciaglia. (App. Br. 13-14; Rep. Br. 2-3, 5)
Appellant argues that the claimed shape of Appellant’s handle
provides for better gripping of a dilator which the prior art fails to recognize
or disclose. (Rep. Br. 5)

3 All references to App. Br. are to the Appeal Brief filed May 22, 2009.
4 All references to Rep. Br. are to the Reply Brief filed October 22, 2009.
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C. Issues
Has the Appellant shown that the Examiner erred in concluding that
one of ordinary skill in the art would have modified the shape of the dilator
of Ciaglia in view of the “S” shape configuration of Kuhn in order to avoid
damage to the vocal cavity and the trachea?
Has the Appellant shown that the Examiner erred in relying on a
general theory of “design choice” where the shape claimed is described as
providing better gripping compared to the prior art and as overcoming a
problem in the art?

D. Discussion
We believe that the Examiner has not articulated a reasonable basis
with rational underpinnings as to how Ciaglia and Kuhn render the claimed
subject matter prima facie obvious. We agree with Appellant that reliance
on Kuhn’s teaching to provide an “S” shape to avoiding harm to the vocal
cavity and the trachea to modify the shape of the dilator of Ciaglia is
misplaced. The “S” shape avoids harm to the vocal cavity by conforming to
the shape of the pharynx, trachea and hypopharynx when the device is
inserted via the mouth into the throat. The Examiner did not explain how the
“S” shape would avoid harm when used as a tracheostomy dilator nor can
we perceive how the alleged benefit would occur. Accordingly we do not
find the avoidance of harm to the vocal cavity and trachea to be a rational
basis to support the conclusion of obviousness.
The second finding by the Examiner that it has been held that a
change in shape of a prior art device is a design consideration within the
skill in the art is also unpersuasive. “Design choice” is appropriate where
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the applicant fails to set forth any reasons why the differences between the
claimed invention and the prior art would result in a different function. In re
Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995). Smiths describes providing a
handle with the claimed shape as overcoming the problem of how to apply a
relatively high insertion force in a controlled manner by using the thumb and
forefinger to provide guidance and the other three fingers to provide the
force. (Spec. 5)
Therefore, we reverse the rejection of Claims 1-12 under 35 U.S.C. §
103. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[R]ejections
on obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.”)

E. New Ground of Rejection
Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter the
following new ground of rejection of claims 1 and 8 under 35
U.S.C. § 102(b) as being anticipated by Buckley of record. Buckley
describes a dilator having a first curved end 12 and a second oppositely
curved end 14 as recited in claim 1. (Figs 1 and 2 and pg. 3, ll. 11-16)
Buckley illustrates dilators having substantially the same radius of curvature
as required by claim 8. (Fig 3)
F. Order

The rejections of Claims 1-12 under 35 U.S.C. § 103(a) as being
unpatentable over Ciaglia and Kuhn is reversed.
We have also entered a new ground of rejection against claims 1 and 8
under 37 C.F.R. § 41.50(b).
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Application 10/685,809

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37 C.F.R. § 41.50(b) provides that, “[a] new grounds of rejection
pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one
of the following two options with respect to the new grounds of rejection to
avoid termination of proceedings (37 C.F.R. § 1.197 (b)) as to the rejected
claims:
(1) Submit an appropriate amendment of the claims so rejected
or new evidence relating to the claims so rejected, or both, and
have the matter reconsidered by the examiner, in which event
the proceeding will be remanded to the examiner…; or

(2) Request that the proceeding be reheard under 37 C.F.R.
§ 41.52 by the Board upon the same record …
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

REVERSED; 37 C.F.R. § 41.50(b)

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