Ex Parte Rapoport

Board of Patent Appeals and Interferences

Mar 11, 2011

10464126 (B.P.A.I. Mar. 11, 2011)

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.
10/464,126 06/18/2003 David M. Rapoport 50124/01701 1168
7590 03/11/2011
FAY KAPLUN & MARCIN, LLP
Suite 702
150 Broadway
New York, NY 10038
EXAMINER
DEMILLE, DANTON D
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
03/11/2011 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 DAVID M. RAPOPORT
__________

Appeal 2009-015228
Application 10/464,126
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and FRANCISCO C. PRATS,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims directed to a system for treating a sleeping disorder. The claims have
been rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-015228
Application 10/464,126

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BACKGROUND
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is
characterized by intermittent obstruction of the upper airway during sleep,
“in part due to the collapsible behavior of the supraglottic segment of the
respiratory airway during the negative intraluminal pressure generated by
inspiratory effort” (Spec. ¶¶ 1-3). Collapse of the upper airway generally
occurs whenever the pressure in the airway drops below the “tissue
pressure” of the surrounding wall of the upper airway (id. at ¶ 5).
In general, positive airway pressure (PAP) therapy “is directed to
maintaining pressure in the collapsible portion of the airway at or above the
critical ‘tissue pressure’ at all times . . . by raising the airway pressure in the
entire respiratory system to a level higher than this critical pressure” (id.).
According to the Specification,
Conventional . . . PAP therapies have either provided a single
continuous pressure at the nose or a combination of such a
continuous pressure with a lowering of pressure when the
pressure is not thought to be needed (e.g., during expiration).
Continuous PAP (‘CPAP’) generally provides a constant
pressure at least as large as the largest pressure necessary to
prevent airway collapse. Some PAP therapies have provided
and modified pressure profiles in an attempt to achieve the
lowest . . . pressure which produces the desired therapeutic
effect.
(Id. at ¶ 6.)
According to the Specification, some PAP systems “adjust pressure to
provide assisted breathing (i.e., to overcome respiratory effort)” (id. at ¶ 16),
and this “may cause patients to inhale more air than they require inducing a
reaction whereby the patient draws less air in subsequent breaths relying on
the system assist to provide the extra air required” (id. at ¶ 23). This, in turn,
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Application 10/464,126

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may cause the system to react “by changing inhalation and exhalation
pressures and a series of system adjustments and patient reactions may be
begun which . . . is never stabilized” (id.).
In an effort to avoid these problems, the Specification discloses a
system “intended to maintain a substantially constant pressure CP” in a
predetermined portion of a patient’s airway (e.g., the collapsible supraglottic
segment) by continuously adjusting the pressure applied, PA, to compensate
for dissipation of pressure along the segments which precede the collapsible
portion of the airway (id. at ¶ 16). “By maintaining the pressure in the
collapsible portion of the airway substantially constant, the patient receives
no breathing assistance and these problems are not encountered. The only
variations in pressure are above the collapsible segment of the airway and do
not . . . reach the lung itself” (id. at ¶ 23).
STATEMENT OF THE CASE
Claims 1-7 and 12-17 are pending and on appeal.2 Representative
claims 1 and 2 are reproduced below:
1. A system for treatment of a sleeping disorder, comprising:
a flow generator supplying a pressurized airflow to an airway of a
patient; and
a processing arrangement connected to the flow generator to control a
supply pressure at which the airflow is generated by the flow generator,
wherein the processing arrangement continuously adjusts the supply
pressure to maintain a pressure in a predetermined portion of the patient’s
airway substantially constant.

2 Claims 8-11 and 18-21 are also pending, but have been withdrawn from
consideration; claim 22 has been allowed (App. Br. 2).
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Application 10/464,126

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2. The system according to claim 1, wherein the predetermined portion
of the patient’s airway includes a collapsible portion of an upper airway of
the patient and wherein the processing arrangement controls the supply
pressure to maintain the pressure in the collapsible portion of the patient’s
airway at a predetermined value.

Claims 1-7 and 12-17 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Remmers (U.S. Patent 5,645,053, July 8, 1997).
We reverse.
ISSUE
Has the Examiner established that Remmers’ system continuously
adjusts the pressure applied to a patient’s airway to maintain a substantially
constant pressure in a predetermined portion of the patient’s airway?
FACT FINDINGS
1. Figure 2b of the Specification shows a schematic airflow
passage:

Figure 2b shows collapsible segment CD of the upper airway (Spec. ¶ 15).
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Application 10/464,126

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2. The Specification teaches “to maintain a substantially constant
pressure CP in the segment CD” (Spec. ¶ 16), the pressure applied, PA,
“needs to be adjusted to compensate for dissipation of pressure along the
segments AB and BC which precede the segment CD because they are
upstream of the flow during inspiration and which add to the pressure
generated during expiration because they are downstream of the flow” (id.).
3. According to the Specification, “[b]y maintaining the pressure
in the collapsible portion of the airway substantially constant, the patient
receives no breathing assistance . . . [and] [t]he only variations in pressure
are above the collapsible segment of the airway and do not extend below . . .
to reach the lung itself” (Spec. ¶ 23). This is in contrast to prior art systems
“that intentionally or unintentionally assist the breathing of patients by
providing different pressures to the patient’s lungs during inhalation and
exhalation” (id.).
DISCUSSION
Appellant contends that Remmers’ system has two modes, testing and
non-testing, neither of which meets the limitations of the claims because
“the air pressure is not maintained constant in any portion of the airway . . .
[but] fluctuates during inspiration and expiration” (App. Br. 6). Specifically,
according to Appellant:
In the testing mode, the system incrementally reduces the
pressure supplied to the mask to determine a critical pressure
(“Pcrit”) (i.e., a pressure at which obstruction occurs in the
patient’s pharyngeal airway during inspiration). . . . After the
Pcrit has been identified, the system incrementally increases the
air pressure to determine an optimum pressure (“Popt”), which
is a minimum effective pressure to eliminate the obstruction
during inspiration. . . . Thus during the testing mode, the system
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Application 10/464,126

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is constantly adjusting a pressure supplied to cause a
corresponding adjustment in the pressure within the airway.
(Id. at 4-5.)
In addition, according to Appellant,
In the non-testing mode, a constant holding pressure of Popt is
supplied to the mask so that the air pressure in the pharangeal
airway, while continuing to vary between inspiration and
exhalation, never falls below the Pcrit. . . . That is, during the
non-testing mode, the pressure supplied is constant, while the
pressure in the airway varies at all times but is maintained
above a critical value Pcrit.
(Id. at 5.)
Essentially, Appellant’s position is that Remmers’ system applies a
constant pressure (Popt) in the non-testing mode to ensure that the pressure
in the collapsible portion of the airway, although fluctuating between
inspiration and expiration, never drops below the critical pressure at which
the airway would collapse. Appellant contends that “the Examiner
erroneously equates the pressure in the patient’s airway with [Remmers’]
optimal applied pressure” and “is merely assuming that . . . the optimized
pressure that is applied to the patient (Popt) will also exist in the patient’s
airway at a substantially constant level” (Reply Br. 4). Appellant contends
“[i]n contrast to Remmers, the present invention continuously adjusts the
supply pressure . . . to maintain a constant pressure in a predetermined
portion of the patient’s airway (i.e., remote from the flow generator)” (App.
Br. 6), regardless of the phase of respiration.
The Examiner acknowledges that it is well known that “the pressure
in the patient’s airway varies during respiration i.e., going from inspiration
to expiration” (Ans. 6). Moreover, the Examiner does not appear to dispute
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Appellant’s assertion that Remmers’ system allows the pressure in the
patient’s airway to fluctuate between inspiration and expiration. Rather, the
Examiner argues that this fluctuation is “irrelevant” because “[t]he purpose
of Popt is to maintain a pressure in the patient’s airway . . . during
inhalation” (id.), that is, “[d]uring inhalation [Remmers’] system maintains
the pressure in the patient’s airway substantially constant at this Popt
pressure to assure the airway remains open” (id.). The Examiner reiterates
that Remmers’ system ensures that “during inspiration the pressure in the
patient’s airway is maintained at the target pressure Popt at a constant level”
(id. at 7).
Nevertheless, the claims on appeal require maintaining a substantially
constant pressure in a predetermined portion of the patient’s airway. When
this limitation is read in light of the Specification, it is clear that it requires
maintaining a constant pressure in the predetermined portion of the airway
regardless of the phase of respiration - not just during inspiration (FF2-3).
Therefore, even if we were to accept the Examiner’s assertion that
Remmers’ system maintains a constant pressure in a portion of the patient’s
airway during inspiration, it would not be sufficient to establish that
Remmers’ system meets the requirements of the claimed invention.
CONCLUSION
The Examiner has not established that Remmers’ system continuously
adjusts the pressure applied to a patient’s airway to maintain a substantially
constant pressure in a predetermined portion of the patient’s airway.
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Application 10/464,126

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SUMMARY
The rejection of claims 1-7 and 12-17 under 35 U.S.C. 102(b) as
anticipated by Remmers is reversed.

REVERSED

DM

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