Ex Parte Pitts

Board of Patent Appeals and Interferences

Feb 24, 2012

09954315 (B.P.A.I. Feb. 24, 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.
09/954,315 09/17/2001 Walter C. Pitts 17415-1 6744
23676 7590 02/24/2012
SHELDON MAK & ANDERSON PC
100 Corson Street
Third Floor
PASADENA, CA 91103-3842
EXAMINER
MANUEL, GEORGE C
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
02/24/2012 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 WALTER C. PITTS
____________

Appeal 2010-012025
Application 09/954,315
Technology Center 3700
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and ERICA A.
FRANKLIN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-11 and 20-30,
the only claims pending in this application. We have jurisdiction under 35
U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method for preventing obstructive sleep
apnea events in a patient. Claims 1 and 8 are representative and are
reproduced in the “CLAIMS APPENDIX” of Appellant‟s Brief (App. Br.
16).
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Application 09/954,315

2
Claims 1-7, 9-11, 20-26, and 28-30 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Meer.
1

Claims 8 and 27 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Meer and Richmond.
2

We affirm.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support a finding
that Meer teaches the method set forth in Appellant‟s claim 1,
notwithstanding the different words used by Appellant and Meer to
characterize the degree of genioglossus muscle contraction?
FACTUAL FINDINGS (FF)
FF 1. Appellant‟s Specification discloses that obstructive sleep apnea
“results from excessive relaxation of the upper airway muscles during sleep”
such that “the base of the tongue collapses posteriorly against the lower
oropharynx and the upper hypopharynx” (Spec. 1: 16-20).
FF 2. Appellant‟s Specification discloses a method, wherein “low level
stimulation” is applied to a patient‟s genioglossus muscle (Spec. 8: 8-10).
FF 3. Appellant‟s Specification defines the term “low level stimulation” as
[E]ither subthreshold or threshold stimulation sufficient to
induce a muscle tone characteristic of an awake person or a
sleeping person without obstructive sleep apnea, or at least
sufficient to retain the position of the tongue out of the airway.
It is not desirable to induce a significant contraction of many

1
Meer, US 4,830,008, issued May 16, 1989.
2
Richmond et al., US 6,240,316 B1, issued May 29, 2001.
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Application 09/954,315

3
motor units, but rather to hold the base of the tongue in a
normal position away from the posterior wall of the airway.

(Spec. 8: 10-15 (emphasis added).)
FF 4. Appellant‟s Specification discloses, “[i]n a preferred embodiment, a
medical device is implanted to deliver mild electrical stimulation to produce
muscle tone without full contraction” (Spec. 5: 19-20 (emphasis added)).
FF 5. Meer‟s invention relates to a method and system for treating sleep
apnea, wherein “upper airway patency in human patients [is maintained] by
stimulating those nerves which activate the patient‟s upper airway muscles”
(Meer, Title and col. 1, ll. 12-15).
FF 6. Meer teaches implanting an effector electrode into “muscles which
include the . . . genioglossus” (Meer, col. 4, ll. 18-25; Ans. 3-4).
FF 7. Meer teaches that “[m]ost preferably, the effector electrode . . .
effects the nerves which stimulate the genioglossus muscle to move the
tongue anteriorly and thus prevent upper airway obstruction when an
electrical signal is received” (Meer, col. 6, ll. 27-30; Ans. 3-4).
FF 8. Meer teaches that “electrical signals . . . stimulate nerves which
activate the patient‟s upper airway muscles to contract in order to maintain
upper airway patency” (Meer, col. 5, ll. 39-43).
FF 9. Rho defines “muscle tone” as “the basal resting state of a muscle”
(Rho Declaration
3
2: ¶ 8).
FF 10. Rho declares that “the state of „muscle contraction‟ is associated
with movement rather than a resting state” (Rho Declaration 3: ¶ 10).

3
Executed July 22, 2004.
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Application 09/954,315

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ANALYSIS
Obstructive sleep apnea “results from excessive relaxation of the
upper airway muscles during sleep” such that “the base of the tongue
[(genioglossus muscle)] collapses posteriorly against the lower oropharynx
and the upper hypopharynx” (FF 1). Appellant and Meer both teach a
method for preventing obstructive sleep apnea, wherein electrodes are used
to stimulate the genioglossus muscle in a manner that prevents the muscle
from obstructing a patient‟s airway and thereby preventing upper airway
obstruction (FF 2-7).
Appellant‟s method requires electrical stimulation that maintains
muscle tone without causing significant contraction of the genioglossus
muscle (see Claim 1). Appellant‟s Specification discloses that the electrical
stimulation required to perform the method represents “subthreshold or
threshold stimulation sufficient to induce a muscle tone characteristic”,
which is “at least sufficient to retain the position of the tongue out of the
airway” (FF 3). Stated differently, Appellant‟s electrical stimulation
produces “muscle tone without full contraction” (FF 4).
Similarly, Meer teaches the application of electrical stimulation to the
genioglossus muscle that is sufficient to retain the position of the tongue out
of the airway (FF 7). Meer, however, uses the words “contract” and “move”
to characterize the effect of the electrical stimulation on the genioglossus
muscle rather than Appellant‟s words - “maintaining tone without
significant[, i.e., full,] contraction” (see FF 7-8; Cf. Claim 1 and FF 3-4).
Thus, the issue distills down to whether the preponderance of evidence on
this record supports a finding that Meer teaches the method set forth in
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Appellant‟s claim 1, notwithstanding the different words used by Appellant
and Meer to characterize the degree of genioglossus muscle contraction.
Appellant relies on Kandel
4
to support their contention that although
“muscle contraction and muscle tone are associated with interrelated and
parallel physiological systems, the systems are nonetheless different” (App.
Br. 13). While this may be true, Appellant‟s claimed method allows for
some degree of contraction as long as it is not “significant”, which
Appellant‟s Specification characterizes as a “full contraction” (see Claim 1
and FF 4). Appellant fails to identify a teaching in Meer that requires
electrical stimulation resulting in a full, or otherwise significant, contraction
of the genioglossus muscle. Accordingly, we are not persuaded by
Appellant‟s contentions regarding Kandel. For the same reason, Rho‟s
discussion of the differences between muscle tone and contraction fall short
of distinguishing Meer from Appellant‟s claim 1 (see FF 9-10; see also App.
Br. 11-12). For the foregoing reasons, we are not persuaded by Appellant‟s
contentions relating to muscle contraction (App. Br. 9-14; Reply Br. 2-4).
We are also not persuaded by Appellant‟s contention that Meer
teaches “movement of the tongue as the mechanism for maintaining airway
patency” (App. Br. 9-10; Reply Br. 3). As discussed above, Appellant‟s
claim 1 permits some degree of contraction and as Rho explains “the state of
„muscle contraction‟ is associated with movement” (FF 10; App. Br. 11; see
generally Ans. 5-6).
In sum, we find that the preponderance of evidence on this record falls
in favor of the Examiner.

4
Kandel et al., Principles of Neural Science 4
th
ed., ch. 34 The Motor Unit
and Muscle Action (2000).
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CONCLUSION OF LAW
The preponderance of evidence on this record supports a finding that
Meer teaches the method set forth in Appellant‟s claim 1, notwithstanding
the different words used by Appellant and Meer to characterize the degree of
genioglossus muscle contraction. The rejection of claim 1 under 35 U.S.C.
§ 102(b) as being anticipated by Meer is affirmed. Because they are not
separately argued, claims 2-7, 9-11, 20-26, and 28-30 fall together with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 11. We adopt Examiner‟s findings concerning the scope and content of
the prior art (Ans. 4).
ANALYSIS
Having found no deficiency in Examiner‟s reliance on Meer relating
to “a method for preventing obstructive sleep apnea events by maintaining
muscle tone of a patient‟s genioglossus muscle without causing significant
contraction of the genioglossus muscle”, we are not persuaded by
Appellant‟s contention that Richmond fails to make up for the deficiencies
in Meer (see App. Br. 14-15).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 8 under 35 U.S.C. § 103(a) as
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Application 09/954,315

7
unpatentable over the combination of Meer and Richmond is affirmed.
Because it is not separately argued, claim 27 falls together with claim 8. 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

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