Ex Parte Norman et al

Board of Patent Appeals and Interferences

Aug 19, 2008

10862067 (B.P.A.I. Aug. 19, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT G. NORMAN and DAVID M. RAPOPORT
__________

Appeal 2008-3513
Application 10/862,067
Technology Center 3700
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Decided: August 19, 2008
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1, 3-16, 18-28, 30-33, and 35-48. We
have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-3513
Application 10/862,067

STATEMENT OF THE CASE
According to the Specification, “[o]bstructive sleep apnea/hypopnea
syndrome (OSAHS) is a well recognized disorder which may affect as much
as 1-5% of the adult population.” (Spec. 1.) While the pathophysiology of
the disorder is not fully understood, “it is now well recognized that
obstruction of the upper airway during sleep is in part due to collapsible
behavior of the supraglottic segment of the respiratory airway during the
negative intraluminal pressure generated by inspiratory effort.” (Id.)
“[P]ositive airway pressure (‘PAP’) applied by a tightly fitted nasal
mask worn during sleep has evolved to become the most effective treatment
for this disorder, and is now the standard of care.” (Id. at 2.) “PAP therapy
is directed to maintaining pressure in the collapsible portion of the airway at
or above the critical ‘tissue pressure’ at all times. This goal is achieved by
raising the airway pressure in the entire respiratory system to a level higher
than this critical pressure.” (Id. at 2-3.)
The Specification teaches that
the determination of the appropriate pressure for therapy,
referred to as PAP titration, is normally performed in a sleep
laboratory where a specific treatment pressure is determined.
However, during the first week of treatment the necessary
pressure to treat the OSDB may decrease, which results in a
prescribed pressure that is too high and may compromise
patient compliance. In addition, the patient may assume body
positions or sleep stages, other than those occurring in the sleep
laboratory that may change the therapeutic pressure. Finally,
patients may require periodic retitration following changes in
condition, such as weight gain or loss. Retitration of the PAP
in the laboratory is usually expensive and is not part of the
usual standard of care. Thus, there is a need for a system and
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method that would provide initial PAP titration and retitration
to patients as required during subsequent treatments.

(Id. at 3.)
The claims are directed to a system for providing air pressure to a
patient’s airway having a titration device that determines the number of
abnormal respiratory events, as well as methods of using the system. Claim
1 is representative of the claims on appeal, and reads as follows:
1. A system, comprising:
an air pressure supply arrangement providing air pressure to a
patient’s airways;
a sensor detecting input data corresponding to a patient’s breathing
patterns for a plurality of breaths for at least one time period; and
a titration device receiving and analyzing the input data to determine a
number of abnormal respiratory events during the at least one time period
and generating output data for adjusting the air pressure supplied to the
patient as a function of the number of abnormal respiratory events during the
at least one time period.

The Examiner relies on the following references:
Remmers US 5,645,053 Jul. 8, 1997
Wright US 6,832,609 B2 Dec. 21, 2004

We affirm.

ISSUE (ANTICIPATION)
The Examiner contends that claims 1, 3-5, 7-11, 13-16, 18-21, 23-27,
37-45, 47, and 48 are anticipated by Remmers (Ans. 3).
Appellants contend that “Remmers does not disclose or suggest ‘a
titration device receiving and analyzing the input data to determine a number
of abnormal respiratory events during the at least one time period and
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generating output data for adjusting the air pressure supplied to the patient as
a function of the number of abnormal respiratory events during the at least
one time period’ as recited in claim 1.” (App. Br. 8.)
Thus, the issue on Appeal is: Has the Examiner established that
Remmers teaches “a titration device receiving and analyzing the input data
to determine a number of abnormal respiratory events during the at least one
time period and generating output data for adjusting the air pressure supplied
to the patient as a function of the number of abnormal respiratory events
during the at least one time period”?

FINDINGS OF FACT
FF1. Claims 1, 3-5, 7-11, 13-16, 18-21, 23-27, 37-45, 47, and 48 stand
rejected under 35 U.S.C. § 102(b) as being anticipated by Remmers (Ans. 3).
FF2. As to the contested limitation, the Examiner finds that Remmers
teaches “a titration device 10 and 12 (see figure 1A) receiving and analyzing
the input data to determine a number of abnormal respiratory events during
the at least one time period and generating output data for adjusting the air
pressure supplied to the patient as a function of the number of abnormal
respiratory events during the at least one time period (see column 6 lines 15-
33).” (Ans. 3-4.)
FF3. The Examiner finds further:
In Remmers the titration device is defined as an adaptive
control system 10 (see column 4 lines 58-67) which receives
and analyzes the input data to determine a number of abnormal
respiratory events. Remmers defines abnormal respiratory
events as OSA (Obstructive Sleep Apnea) or other sleeping
disorders (see background of the invention; column 1 lines 15-
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20). During the at least one time period (time period in a broad
sense is defined as 5 to 10 breaths as stated in Remmers; see
column 6 lines 15-30) and generating output data (see column 6
lines 20-67; hypoventilation is defined as means inspiratory
flow being less than 40% of the predicted awake supine means
inspiratory flow within five breaths (time period) and apnea is
defined as a 10 seconds duration of no change in respiratory
phase within five breaths (time period) and if these events occur
with the time period, the device would correct the air pressure
supplied to the patient) for adjusting the air pressure supplied to
the patient as a function of the number of abnormal respiratory
events during the at least one time period.

(Ans. 9-10 (emphasis removed).)
FF4. Remmers is drawn to
systems and methods for adaptively providing continuous
positive airway pressure [CPAP] to an upper airway system by
detecting airflow data in the upper airway system at
predetermined increments of time; averaging said airflow data
over a second period of time which includes a plurality of said
predetermined time increments; determining non-respiratory
airflow using said averaged data; identifying periods of
inspiration and expiration using said non-respiratory airflow
data; extracting information or features from said airflow data;
and continuously adjusting pressure in said upper airway
system.

(Remmers col. 2, ll. 43-53.)
FF5. An adaptive control operator is part of the system, and serves as an
overseer that has access to the feature extractor (which monitors the patient’s
breathing) at all times (Remmers col. 5, ll. 58-65; col. 7, ll. 31-36).
FF6. During both testing and non-testing periods, “the adaptive control
system continuously monitors breathing variations, hypoventilation, apnea,
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and signs that the threshold detection mechanism has not been properly
adjusted for leaks.” (Remmers col. 6, ll. 48-52.)
FF7. The adaptive control system
generates an optimal desired (i.e., command) pressure by
averaging airflow data over a predetermined period of time,
partitioning airflow data into respiratory and non-respiratory
components, identifying periods of inspiration and expiration
using the non-respiratory component, and extracting
information or features from airflow data. Using this
information, the adaptive control system identifies a critical
pressure (Pcrit) at which a significant obstruction occurs during
inspiration. More particularly, Pcrit corresponds to a lower limit
of mask pressure associated with a significant decrease in peak
inspiratory airflow and/or significant (i.e., critical) airflow
limitation. After determining Pcrit, the adaptive control system
identifies an optimum (i.e., minimum) effective CPAP (Popt) for
eliminating the obstruction during inspiration.

(Remmers col. 5, ll. 8-23.)
FF8. Testing periods are used to determine Pcrit and Popt (Remmers col. 11,
ll. 45-54).
FF9. If during testing an apnea, hypoventilation, or respiratory variation
error is detected, the testing mode is exited and the system returns to the
previous holding pressure (col. 12, 11. 62-65).
FF10. In operation of the system, after start-up, the adaptive control system
operator enters a non-testing mode (col. 16, ll. 35-37). An interval count is
used to keep track of the number of breaths, in which each interval count
represents ten breaths (col. 16, ll. 45-46). After two intervals, the testing
protocol is entered if there are no breathing instabilities (i.e., apnea,
hypoventilation, variable breathing) (col. 16, ll. 53-55). If breathing
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instabilities are detected, the testing protocol may be delayed up to three
more interval counts (30 breaths) (col. 16, ll. 55-61). If breathing
instabilities are determined after 50 breaths, the consistency of the instability
is sufficient to start the testing protocol (col. 16, ll. 62-67).
FF11. Remmers teaches:
During a testing mode, a search is first made for Pcrit. Once Pcrit
has been determined, a search is made for Popt. In the testing
mode, the system continuously checks for apnea,
hypoventilation and/or variable breathing (blocks 70, 72 and
74). If any of these instabilities are detected (or any changes in
these values are detected in the case where the test mode was
entered after 50 breaths), testing is stopped (block 76). The
non-test interval count is reset to zero (block 78) and the system
returns to a non-test mode.

(Col. 17, ll. 1-9.)
FF12. In the system of Remmers, therefore, the adaptive control system
(referred to as the titration device in the appealed claims) analyzes input
data, and during a testing period, determines a number of abnormal
respiratory events. If the number of respiratory events is zero, a new
optimum effective continuous positive airway pressure is determined and
adopted. If the number of respiratory events is one or more, the testing
period is halted and the system reverts to the previous effective continuous
positive airway pressure.

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PRINCIPLES OF LAW
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001).
In addition, during prosecution before the Office, claims are to be
given their broadest reasonable interpretation consistent with the
Specification as it would be interpreted by one of ordinary skill in the art. In
re American Academy of Science Tech Center, 367 F.3d 1359, 1364 (Fed.
Cir. 2004. “An essential purpose of patent examination is to fashion claims
that are precise, clear, correct, and unambiguous. Only in this way can
uncertainties of claim scope be removed, as much as possible, during the
administrative process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
Moreover, it is during prosecution that applicants have “the opportunity to
amend the claims to obtain more precise claim coverage.” American
Academy, 367 F.3d at 1364.

ANALYSIS
As to claim 1, Appellants argue that Remmers teaches “an adaptive
control system 10 that utilizes a testing mode to determine a critical pressure
. . . at which airway obstruction occurs during inspiration and an optimum
pressure . . . for eliminating the obstruction during inspiration.” (App. Br.
6.) According to Appellants, during the non-testing mode, the optimum
pressure is delivered to the patient (id. at 6-7).
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Appellants argue further that Remmers teaches that the testing mode
is utilized only “when there is ‘(1) a low to moderate level of variation in
respiratory features, (2) no hypoventilation and (3) no apnea.’” (App. Br. 7
(quoting Remmers col. 6, ll. 7-11).) Appellants assert that Remmers teaches
that a detection of any of the above events ends the analysis and the system
determines whether to enter/continue the testing mode “based on a singular
instance of one of these events and does not disclose or suggest determining
a number of such events during a time period, and clearly neither shows nor
suggests adjusting any pressure based on such a number of events.” (App.
Br. 7.)
Appellants’ arguments are not found to be convincing. Claim 1
requires “a titration device receiving and analyzing the input data to
determine a number of abnormal respiratory events during the at least one
time period and generating output data for adjusting the air pressure supplied
to the patient as a function of the number of abnormal respiratory events
during the at least one time period.” As noted above (FF12), Remmers
teaches an adaptive control system (“the titration device”) which analyzes
input data during a testing period, and determines a number of abnormal
respiratory events. If the number of respiratory events is zero, a new
optimum effective continuous positive airway pressure is determined and
adopted. If the number of respiratory events is one or more, the testing
period is halted and the system reverts to the previous effective continuous
positive airway pressure (FF9). Thus, depending on the number of abnormal
respiratory events, in the case of Remmers, zero or one, the adaptive control
system adjusts the air supply supplied to the patient. Note that there is
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nothing in claim 1 that excludes the number of abnormal respiratory events
being zero or one.

CONCLUSION
Thus, we find that Remmers anticipates claim 1, and as Appellants do
not offer any additional arguments as to the other rejected claims, i.e., claims
3-5, 7-11, 13-16, 18-21, 23-27, 37-45, 47, and 48,1 the rejection is affirmed
as to those claims as well. 37 C.F.R. § 41.37(c)(1)(vii).
Moreover, the Examiner rejected claims 6, 12, 22, 28, 20-33, 35, 36,
and 46 under 35 U.S.C. § 103(a) as being obvious over the combination of
Remmers and Wright. As Appellants only argue that Wright does not cure
the deficiencies of Remmers, the rejection is affirmed for the reasons set
forth above with respect to the anticipation rejection over Remmers.

TIME LIMITS
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

Ssc

1 As to independent claims 13 and 28, Appellants merely reiterate their
arguments as to claim 1 (App. Br. 8-9).
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