Ex Parte Davis et al

Board of Patent Appeals and Interferences

Apr 10, 2012

10966629 (B.P.A.I. Apr. 10, 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.
10/966,629 10/14/2004 Ross Davis A345-USA 7925
24677 7590 04/11/2012
ALFRED E. MANN FOUNDATION FOR
SCIENTIFIC RESEARCH
PO BOX 905
SANTA CLARITA, CA 91380
EXAMINER
LAVERT, NICOLE F
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
04/11/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROSS DAVIS, YITZHAK ZILBERMAN,
and GREGOIRE COSENDAI
__________

Appeal 2010-012377
Application 10/966,629
Technology Center 3700
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a sleep
apnea treatment method. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1-4, 8-10, and 26 are on appeal (App. Br. 2). Claim 1 is
representative and reads as follows:
Appeal 2010-012377
Application 10/966,629

2
1. A method of treating sleep apnea in a patient comprising:
providing a first microstimulator proximate to a first hypoglossal
nerve (HGN);
providing a second microstimulator proximate to a second HGN;
monitoring a breathing pattern of the patient and predetermining a
first and a second stimulation length of time based on the breathing pattern;
stimulating the first HGN for the first predetermined length of time;
and
stimulating the second HGN for the second predetermined length of
time.
Claims 1-4, 8-10, and 26 stand rejected under 35 U.S.C. § 103(a) as
obvious over Testerman et al. (US 5,522,862, Jun. 4, 1996) in view of
Freed et al. (US 5,891,185, Apr. 6, 1999) (Ans. 3).
The Examiner relies on Testerman for disclosing “a method of
treating sleep apnea comprising . . . providing a first microstimulator
proximate to a first hypoglossal nerve (HGN); stimulating for a first
predetermined length of time . . . [; and m]onitoring a breathing pattern of
the patient and predetermining a first length of time based on the breathing
pattern” (id.). The Examiner relies on Freed for teaching “that it is known to
use a method and apparatus for treating oropharyngeal disorders by
providing electrical stimulation to a plurality of electrodes located in the
pharyngeal region, and more specifically located at the left and right . . .”
(id. at 4). The Examiner concludes that it would have been obvious
to modify the method of treating sleep apnea as taught by
Testerman et al. with the use of providing electrical stimulation
to a plurality [of] electrodes located at the left and right HGNs
. . . to utiliz[e] the strongest, most complete electrical stimulus
to the pharyngeal region in order to control the region for
breathing.
(Id.)
Appeal 2010-012377
Application 10/966,629

3
FINDINGS OF FACT
1. The Specification discloses that “the present invention is
directed to a method and system for treating sleep apnea . . . using at least
two small implantable microstimulators, also referred to as BIONTM
devices” (Spec. 4-5).
2. The Specification also discloses that “a typical
microstimulator 100 or 102 comprises a biocompatible housing 202 having a
coupling coil 204, an electrical circuitry 206 for power reception and data
communication, a pulse generator 208 and current source 210 for providing
electrical supply to the electrode 212 for stimulation” (id. at 5-6).
3. Testerman discloses
a method for treating sleep apnea by bursts of electrical
stimulation in response to sensed inspiration which includes
detecting an arousal event and thereafter maintaining
stimulation intensity in response to sensed inspiration below
that which is perceptible to the patient. This level of
stimulation is maintained for a predetermined period of time
after detection of the arousal event in order to allow the patient
to return to sleep without perceptible upper airway stimulation.
(Testerman, col. 2, ll. 49-57.)
4. Testerman Figure 33 is reproduced below:
App
App

“In F
exter
Test
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lication 10
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/966,629
e system .
itter/contr
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troller 55
stimulate
patient 60
hypoglos
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imulation
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response
sends stim
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0. . . . The
sal nerve 6
Testerman
be implem
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is provide
4
n as it is u
Testerman
to the sens
ulus pulse
irway mus
stimulatio
30.” (Id.
discloses
ented in a
4. In FIG
d from the
sed on a p
, col. 17,
ed wavefo
s through
cle 626 (i.
n electrod
at col. 17,
that a “de
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ll. 52-54).
rm,
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ll. 58-67.)
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Appeal 2010-012377
Application 10/966,629

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lead 718 to an electrode 720 around the hypoglossal nerve 730.” (Id. at
col. 18, ll. 1-34.)
6. Freed discloses “a method and apparatus for treating
oropharyngeal disorders by providing electrical stimulation to the
pharyngeal region of an associated animal” (Freed, col. 1, ll. 15-17).
7. Freed also discloses that the device “preferably includes at least
two electrodes” (id. at col. 4, l. 11).
8. In addition, Freed discloses:
The electrodes are selectively placed in any suitable site within
the pharyngeal region 200 of the patient as shown in FIGS. 3
and 4. The placement of the electrodes in the pharyngeal region
of the patient is based on several factors, such as the extent and
type of oropharyngeal disorder exhibited by the patient and,
given the extent and type of oropharyngeal disorder exhibited,
those locations within the pharyngeal region, when subjected to
electrical stimulus, have the possibility of eliciting the strongest
and most complete swallow.
(Id. at col. 10, ll. 18-27.)
9. Freed also discloses that a pair of electrodes is positioned on the
skin of the pharyngeal region on either side of the midline of the pharyngeal
region (id. at col. 10, ll. 34-62).
ANALYSIS
Testerman discloses a method for treating sleep apnea comprising
stimulating the first HGN with a stimulation electrode (Findings of Fact (FF)
3-5). Freed discloses the use of two electrodes positioned on either side of
the pharyngeal region to treat oropharyngeal disorders by providing
electrical stimulation to the pharyngeal region (FF 6-9). We conclude that
these references support the Examiner’s conclusion that it would have been
Appeal 2010-012377
Application 10/966,629

6
obvious to stimulate each HGN with a stimulation electrode in an effort to
provide a more complete treatment for sleep apnea.
Appellants argue, however, that “Testerman does not disclose a
microstimulator proximate to a first hypoglossal nerve” (App. Br. 3). We
are not persuaded.
First, we do not agree with Appellants that the device needs to be
implanted to be considered proximate to the HGN. “[W]hile it is true that
claims are to be interpreted in light of the specification . . . , it does not
follow that limitations from the specification may be read into the claims.”
Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988). Moreover,
Testerman discloses that the device can “be implemented in a fully
implantable stimulation system” (FF 5).
Second, although one of ordinary skill in the art may not consider an
electrode by itself to be a microstimulator, Appellants have not explained
why it would have been unreasonable to consider an electrode connected
(physically or otherwise) to a pulse generator to be a microstimulator. Given
that Testerman’s electrode, which is connected to a pulse generator, is
sufficiently close to the HGN so as to stimulate it (FF 4-5), we conclude that
it was reasonable for the Examiner to consider Testerman’s stimulator to be
proximate to the HGN.
Appellants also argue that, as supported by the Declaration of Ross
Davis, “one skilled in the art would not combine Testerman and Freed in the
manner contended by the Examiner” (App. Br. 6). We are not persuaded.
Appeal 2010-012377
Application 10/966,629

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We agree with Appellants that “Freed is presenting a treatment for
swallowing difficulties,” not sleep apnea (Dec.1 ¶ 7). However, the
Examiner does not rely on Freed for teaching sleep apnea. Instead, Freed is
being relied to show, essentially, that it was known to stimulate the
pharyngeal region at two locations on either side of the midline (Ans. 4).
Therefore, we conclude that the Declaration does not provide sufficient
factual basis to support its conclusion that one of ordinary skill in the art
“would not rely on Testerman in combination with Freed to teach direct
stimulation of each of the two hypoglossal nerves from two precisely
implanted microstimulators to remedy sleep apnea, and physiologically, not
interfere with other pharyngeal systems” (Dec. ¶ 7).
CONCLUSION
The evidence supports the Examiner’s conclusion that claim 1 would
have been obvious. We therefore affirm the obviousness rejection of
claim 1. Claims 2-4, 8-10, and 26 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
TIME PERIOD FOR RESPONSE
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

cdc

1 Declaration of Ross Davis, M.D., submitted on July 28, 2008.