SMITHS MEDICAL INTERNATIONAL LIMITED

Patent Trials and Appeals Board

Oct 26, 2021

2021002757 (P.T.A.B. Oct. 26, 2021)

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.
15/112,785 07/20/2016 Steve Chambers 0119/0144 6828
135866 7590 10/26/2021
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
GALLEGOS, CANA A
ART UNIT PAPER NUMBER
3785
MAIL DATE DELIVERY MODE
10/26/2021 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 STEVE CHAMBERS
____________

Appeal 2021-002757
Application 15/112,785
Technology Center 3700
____________

Before BIBHU R. MOHANTY, CYNTHIA L. MURPHY,
BRADLEY B. BAYAT, Administrative Patent Judges.

MOHANTY, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 9–17. We have jurisdiction under
35 U.S.C. § 6(b).

SUMMARY OF THE DECISION
We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Smiths Medical
International Limited (Appeal Br. 3).
Appeal 2021-002757
Application 15/112,785
2

CLAIMED SUBJECT MATTER
The Appellant’s claimed invention relates to tracheal tubes with a
shaft and an inflatable sealing cuff on its outside towards its patient end
(Spec. 1, ll. 2, 3). Claim 9, reproduced below, is representative of the
subject matter on appeal.

9. A tracheostomy tube comprising:
a shaft including a patient end and a cuff having an
inflatable portion on an outside surface of the shaft towards the
patient end that is adapted, during use, to provide a seal with
the tracheal wall, the cuff being attached to the shaft by means
of a patient end collar and a machine end collar, the shaft being
a tubular shaft having a bore extending along its length, the
bore adapted to receive a removable inner cannula, wherein at
least the patient end collar is inverted within the inflatable
portion of the cuff so that it does not extend beyond the
inflatable portion of the cuff, and wherein the patient end collar
is attached to the outside surface of the shaft immediately
adjacent the patient end of the shaft so that substantially no part
of the shaft protrudes from the inflatable portion of the cuff and
that the cuff has an inflated shape with a tapering substantially
frusto-conical profile at a patient end region such that the
inflated portion of the cuff only extends substantially right to
the patient end of the shaft so as not to extend beyond the
patient end of the shaft.

THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Name Reference Date
Pagan GB 2 344 528 A Nov. 17, 1999
Lieberman US 4,596,248 June 24, 1986
Nelson US 2007/0295337 A1 Dec. 27, 2007
Behlmaier US 2012/0103341 A1 May 3, 2012

Appeal 2021-002757
Application 15/112,785
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The following rejections are before us for review:
1. Claims 9, 10, and 13–16 are rejected under 35 U.S.C. § 103 as
unpatentable over Lieberman, and an alternative embodiment of Lieberman
in Figure 2, and Nelson.
2. Claim 17 is rejected under 35 U.S.C. § 103 as unpatentable
over Lieberman, an alternative embodiment of Lieberman in Figure 2,
Nelson, and Behlmaier.
3. Claims 11 and 12 are rejected under 35 U.S.C. § 103 as
unpatentable over Lieberman, an alternative embodiment of Lieberman in
Figure 2, Nelson, and Pagan.

FINDINGS OF FACT
We have determined that the findings of fact in the Analysis section
below are supported at least by a preponderance of the evidence2.

ANALYSIS
The Appellant argues that the rejection of claim 9 is improper because
the cited combination of references is improper and would not have been
obvious (Appeal Br. 5–15, Reply Br. 1–6). In particular, the Appellant
argues that claim 9 requires “a tubular shaft having a bore extending along
its length, the bore adapted to receive a removable inner cannula” which is
not suggested by the combination (Appeal Br. 9, emphasis omitted). The
Appellant also argues that the rejection has improperly combined the

2 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988)
(explaining the general evidentiary standard for proceedings before the
Patent Office).
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Application 15/112,785
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references to meet the claim limitation that the “substantially no part of the
shaft protrudes from the inflatable portion of the cuff” (Appeal Br. 10).
In contrast, the Examiner has determined that the rejection of record is
proper (Final Act. 3–5, 9, 10, Ans. 10–12).
We agree with the Appellant. Here, claim 9 in part requires: 1) “a
tubular shaft having a bore extending along its length, the bore adapted to
receive a removable inner cannula”; 2) that “substantially no part of the shaft
protrudes from the inflatable portion of the cuff”; and 3) that the cuff has an
inflated shape with a tapering “substantially right to the patient end of the
shaft so as not to extend beyond the patient end of the shaft.”
The Examiner has determined that claim 9 is obvious under
Lieberman’s embodiment of Figures 10 and 12, in view of Lieberman’s
embodiment of Figures 1 and 2; and Nelson (Final Act. 3-5, 9, Ans. 10–12).
Claim 9 requires “a tubular shaft having a bore extending along its length,
the bore adapted to receive a removable inner cannula.” Lieberman in
Figure 2 fails to show such a tubular shaft with a bore extending along its
length, and in contrast the structure has a perpendicular bend between
members 20 and 30 such that the bore in member 30 does not extend along
the length of the shaft as claimed. Lieberman in the embodiment of Figure
10 also shows the shaft portion (127) protruding beyond the cuff (135).
Lieberman at Figure 1 does show a cuff (35) placed at the end of the device.
The rejection further requires a modification to include Nelson’s teaching of
a frusto-conical end portion of the cuff for a better seal (Lieberman, Fig. 1,
para. 34).
The rationale for modification in the Final Office Action states that
Lieberman’s location for the end collar in Figure 2 is a “known location” for
an inflatable cuff for providing a seal and that Nelson’s frusto-conical shape
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Application 15/112,785
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ensures a tight seal (Final Act. 4, 5; Ans. 11). The Final Office Action states
that Lieberman’s end collar in Figure 2 provides a “known location” for
mounting, but the rejection fails to provide articulated reasoning with
rational underpinnings for a modification to have “substantially no part of
the shaft protrud[ing] from the inflatable portion of the cuff” in the cited
combination without impermissible hindsight. In the embodiment of Nelson
at Figure 10 the shaft portion (127) protruding beyond the cuff (135) has
substantially no effect on the seal as it merely protrudes from the center of
the device and has no engagement with the sealing surface. Here, the
rejection of record lacks articulated reasoning with rational underpinning to
modify the tracheal tube of Lieberman in Figure 10 to have the cuff moved
to the location disclosed by Lieberman in Figure 2 with substantially no part
of the shaft protruding from the cuff,” and to further include the frusto-
conical end cuff disclosed by Nelson without impermissible hindsight and a
conclusion of obviousness has not been shown.
Accordingly, the rejection of claim 9 and its dependent claims are not
sustained. Claim 17 contains similar limitations as claim 9, and the rejection
of this claim is not sustained for the same reasons given above.

CONCLUSIONS OF LAW
We conclude that the Appellant has shown that the Examiner erred in
rejecting claims 9, 10, and 13–16 under 35 U.S.C. § 103 as unpatentable
over Lieberman, an alternative embodiment of Lieberman in Figure 2, and
Nelson.
We conclude that the Appellant has shown that the Examiner erred in
rejecting claim 17 under 35 U.S.C. § 103 as unpatentable over Lieberman,
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Application 15/112,785
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an alternative embodiment of Lieberman in Figure 2, Nelson, and
Behlmaier.
We conclude that the Appellant has shown that the Examiner erred in
rejecting claims 11 and 12 under 35 U.S.C. § 103 as unpatentable over
Lieberman, an alternative embodiment of Lieberman in Figure 2, Nelson,
and Pagan.
DECISION SUMMARY

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
9, 10, 13–16 103 Lieberman, an
alternative
embodiment of
Lieberman in
Figure 2, Nelson
9, 10, 13–16
17 103 Lieberman, an
alternative
embodiment of
Lieberman in
Figure 2, Nelson,
Behlmaier
17
11, 12 103 Lieberman, an
alternative
embodiment of
Lieberman in
Figure 2, Nelson,
Pagan
11, 12
Overall
Outcome
9–17

REVERSED