John M. O'Day

Patent Trials and Appeals Board

Jul 30, 2019

14621722 - (D) (P.T.A.B. Jul. 30, 2019)

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.
14/621,722 02/13/2015 John M. O'Day 3747-13324US(JOD-001US) 2160
24247 7590 07/30/2019
TRASKBRITT, P.C.
P.O. BOX 2550
SALT LAKE CITY, UT 84110
EXAMINER
BAKER, ADAM D
ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
07/30/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
USPTOMail@traskbritt.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JOHN M. O’DAY
____________________

Appeal 2019-004536
Application 14/621,7221
Technology Center 3700
____________________

Before MURRIEL E. CRAWFORD, PHILIP J. HOFFMANN, and
AMEE A. SHAH, Administrative Patent Judges.

HOFFMANN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s rejection of claims 1–14 and 16–21. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
According to Appellant, the “invention relates . . . to a nasopharyngeal
device used to reduce or eliminate obstructive sleep apnea episodes.” Spec.

1 “The real party in interest . . . is Dr. John M. O’Day, who is the sole
inventor.” Appeal Br. 2
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¶ 2. Claims 1, 8, and 21 are the independent claims on appeal. Below, we
reproduce claim 1 as illustrative of the appealed claims.
1. A nasopharyngeal device for obstructive sleep
apnea syndrome, comprising
a semi-rigid, solid-walled tube, the tube comprising:
a proximal end;
a distal end;
a proximal opening; and
a distal opening;
a reversibly inflatable balloon-cuff located at the
distal end of the tube, wherein:
the length of the tube is configurable such that
when inserted to define a nasopharyngeal airway the
balloon-cuff is positioned substantially in the
nasopharynx, and
when inflated, the balloon-cuff maintains
patency of the nasopharyngeal airway by advancing
forward and stenting open the soft palate and defines
an area of the nasopharyngeal airway substantially in
the nasopharynx through which air flow is not allowed
except through the distal opening of the tube,
at least one cup located at the proximal end of the
tube;
an access port located remote from the balloon-cuff;
an inflation port located at the balloon-cuff; and
an inflation channel operably coupling the access port
to the inflation port and for inflating and deflating the
balloon-cuff via the access port and the inflation port.

REJECTIONS AND PRIOR ART
The Examiner rejects the claims as follows:
I. Claims 1, 2, 8, 9, 16, 17, 19, and 20 under 35 U.S.C. § 103 as
unpatentable over Friedman et al. (US 2011/0226264 A1, pub.
Sept. 22, 2011) (“Friedman”) and Dragisic (US 6,536,437 B1,
iss. Mar. 25, 2003);
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Application 14/621,722

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II. Claims 3, 5, 7, 10, 12, and 14 under 35 U.S.C. § 103 as
unpatentable over Friedman, Dragisic, and Brekke
(US 3,915,173, iss. Oct. 28, 1975);
III. Claims 4 and 11 under 35 U.S.C. § 103 as unpatentable over
Friedman, Dragisic, and Santin et al. (US 2006/0085027 A1,
pub. Apr. 20, 2006) (“Santin”);
IV. Claims 6 and 13 under 35 U.S.C. § 103 as unpatentable over
Friedman, Dragisic, and Barodka (US 2012/0118297 A1, pub.
May 17, 2012);
V. Claim 18 under 35 U.S.C. § 103 as unpatentable over
Friedman, Dragisic, and Pourquier (US 3,568,678, iss. Mar. 9,
1971); and
VI. Claim 21 under 35 U.S.C. § 103 as unpatentable over
Friedman, Dragisic, and Kahn et al. (US 5,105,807, iss.
Apr. 21, 1992) (“Kahn”).

ANALYSIS
Rejection I
In independent claim 1’s rejection, although the Examiner relies on
Friedman to disclose certain claim recitations, the Examiner does not rely on
Friedman to disclose the claimed balloon-cuff. See, e.g., Final Action 4–6.
Nonetheless, according to the Examiner,
[i]t would have been obvious . . . to replace the tube and
balloon structure of Friedman . . . with the tube/balloon as
taught by Dragisic while maintaining the placement of
Friedman . . . to maintain device function, the combination
would result in a device having better control of airflow
(Dragisic col[.] 3[,] l[.] 24) without damaging the user via
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Application 14/621,722

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maintaining the device in place (Dragisic col[.] 3[,]
l[l.] 11–13).
Id. at 6. By way of further explanation, according to the Examiner, it would
have been obvious to use Dragisic’s inflatable cuff 14 in the nasopharynx,
which is where Friedman’s expander 135 resides. See, e.g., Answer 3–5;
see, e.g., Dragisic Fig. 4; see, e.g., Friedman Fig. 11, ¶ 121.
Appellant argues that the Examiner errs, because the proposed
combination uses Dragisic’s inflatable cuff 14 that is not suitable for use in
the nasopharynx, which is Friedman’s intended use. Appeal Br. 15–18.
Based on our review, Appellant persuades us that the Examiner errs.
Friedman is directed to a “medical appliance for the treatment of one
or more sleep disorders such as obstructive sleep apnea.” Friedman,
Abstract. As discussed above, in an embodiment, Friedman locates
expander 135 in nasopharynx region 113. Id. at Fig. 11, ¶ 121. Dragisic,
however, is directed to “a cuffed nasal airway [on an] anesthetic wand.”
Dragisic col. 1, ll. 7–9. Dragisic locates inflatable cuff 14 “to seal the cavity
of a patient between the base of the tongue, the soft palate[,] and the lateral
pharyngeal wall”—that is, outside of the nasopharynx region. Id. at col. 4,
ll. 16–20, Fig. 4. There is no indication, in either reference, that one may
position Dragisic’s inflatable cuff 14 in the nasopharynx region. Further,
Appellant submits evidence, in the form of an affidavit by the inventor, Dr.
O’Day, which states that “Dragisic’s inflatable cuff would not be tolerated in
the nasopharynx, it would fill the space and be very uncomfortable and
possibly damage tissue.” Declaration of Dr. John M. O’Day (dated Mar. 26,
2018), ¶ 9.
The Examiner neither adequately addresses the factual evidence
provided by Appellant, nor otherwise adequately supports that one may use
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Dragisic’s cuff, which is never shown or described as suitable for use in the
nasopharynx, in this location. The Examiner responds with statements such
as “there is no mention in the art of Friedman that the characteristics of
Dragisic would render the device inoperable,” and
[t]he device of Dragisic is passed through the nasopharynx, thus
is proven to not damage when deflated, and the device of
Dragisic has portions that are inflated behind the soft palate,
thus part of the device is in the nasopharynx and is proven to
not damage it. Further the comfort or a minimal amount of
damage to a user is not sufficient evidence to infer that no
person would make or use the device, especially considering the
advantages provided with the claimed device.
Answer 14. After reviewing the record as a whole, we are persuaded by
Appellant that the proposed modification would render Friedman’s device
unsuitable for use in the nasopharynx, which is Friedman’s intended use.
Thus, based on the foregoing, we do not sustain the Examiner’s
obviousness rejection of independent claim 1. We also do not sustain the
Examiner’s rejection of independent claim 8, which recites a similar
recitation as claim 1, and the rejection of claims 2, 9, 16, 17, 19, and 20 that
depend from these independent claims.

Rejections II–V
Claims 3–7, 10–14, and 18 depend from independent claims 1 and 8.
The Examiner does not rely on any of Brekke, Santin, Barodka, or Pourquier
to disclose anything that would remedy the above-discussed deficiency in
the independent claims’ rejection. Thus, we do not sustain the Examiner’s
obviousness rejections of dependent claims 3–7, 10–14, and 18.
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Rejection V
Independent claim 21 recites a similar recitation as claim 1, discussed
above. The Examiner does not rely on Kahn to disclose anything that would
remedy the above-discussed deficiency in claim 1’s rejection. Thus, we do
not sustain the Examiner’s obviousness rejection of claim 21.

DECISION
We REVERSE the Examiner’s obviousness rejections of claims 1–14
and 16–21.

REVERSED