Ex Parte Wang et al

Patent Trial and Appeal Board

Nov 14, 2017

12165025 (P.T.A.B. Nov. 14, 2017)

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.
12/165,025 06/30/2008 Hui Wang H-NE-00221/TYHO: 0044 1297
52144 7590
Covidien LP
ATTN: IP Legal
6135 Gunbarrel Avenue
Boulder, CO 80301
11/16/2017 EXAMINER
JIAN, SHIRLEY XUEYING
ART UNIT PAPER NUMBER
3769
NOTIFICATION DATE DELIVERY MODE
11/16/2017 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):
ip.legal@covidien.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HUI WANG and SCOTT AMUNDSON1
Appeal 2016-007603
Application 12/165,025
Technology Center 3700
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a physiological monitor and alarm system. The Examiner rejects the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Covidien LP. Appeal
Br. 2.
Appeal 2016-007603
Application 12/165,025
STATEMENT OF THE CASE
Claims 1, 2, 6, 7, and 16—31 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows (emphasis added):
1. An alarm system comprising:
a physiological monitor configured to trigger an inaudible
first alarm without triggering an audible first alarm
at the physiological monitor in response to an
alarm condition, based on an alarm silencing
setting, and wherein the physiological monitor is
configured to override the alarm silencing setting
based on an alarm urgency, and
a station located remotely from the physiological monitor,
wherein the station is configured to receive an
input from the physiological monitor and trigger a
second alarm at the station in response to the alarm
condition, and wherein when the second alarm is
not acknowledged, the station sends an output to
the physiological monitor to initiate an escalated
audible alarm at the physiological monitor.
6. The system of claim 1, wherein the first alarm and the
second alarm are triggered simultaneously.
Appellants request review of the following rejection made by the
Examiner:
Claims 1, 2, 6, 7, and 16—31 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Mannheimer2 in view of Smith3 and further in
view of Williams.4
2 Paul D. Mannheimer, US 2007/0106126 Al, published May 10, 2007
(“Mannheimer”).
3 Toby E. Smith et al., US 2007/0040692 Al, published Feb. 22, 2007
(“Smith”).
4 Christopher E. Williams & Mark I. Gunning, US 6,406,427 Bl, issued
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As Appellants do not argue the claims separately, we focus our
analysis on claim 1; claims 2, 6, 7, and 16—31 stand or fall with that claim.
37 C.F.R. § 41.37(c)(l)(iv); see Appeal Br. 7—8 (noting that all independent
claims require “a processor configured to override an alarm silencing setting
based on an alarm urgency’'’).
Obviousness over Mannheimer, Smith, and Williams
The Examiner finds that Mannheimer teaches a physiological monitor
and alarm system. See Ans. 3. Mannheimer teaches “escalating] audible
alarm at the physiological monitor (. . . increasing alarm level and
annoyance level).” Ans. 3. The Examiner finds that even though
“Mannheimer does not explicitly disclose a primary inaudible alarm at the
patient monitoring device without triggering] an audible alarm” this
limitation would still have been obvious because Mannheimer also teaches
“visual or haptic alarm[s].” Ans. 3. “Smith discloses simultaneously
triggering an audible alarm at a bedside physiological monitor and at a
remote station . . . .” Ans. 4. Smith also teaches triggering an “an inaudible
alarm because [the] audible alarms would have been disabled” by the
presence of a caregiver. Ans. 4.
The Examiner finds that “Manheimer [sic] in view of Smith only
disclose alarm silence exceptions or over-riding based on setting, and does
not disclose overriding the silence preferences based on alarm urgencies.”
The Examiner relies on Williams for teaching a medical monitoring device
“that has an alarm system which organizes audible and inaudible alarms
June 18, 2002 (“Williams”).
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according to alert urgency.” Ans. 4. The Examiner concludes that the
combination would allow the system to “over-ride alarm silence settings to
sound an alert in accordance with alarm urgency. This distinguishes
technical malfunction, which are low urgency, to other medically high
urgency alarms; this way a caregiver would be notified accordingly and
alarms would not be silenced in error.” Ans. 4.
Appellants contend that “the combination of Mannheimer, Smith, and
Williams fails to teach overriding an alarm silencing setting based on alarm
urgency, either manually or automatically.” Reply Br. 7.
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that the combination of references teach
“overrid[ing] the alarm silencing setting based on an alarm urgency” as
claimed?
Findings of Fact
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art. See Answer and Final Office Action.5
For emphasis only we highlight the following:
FF1. Mannheimer teaches using a physiological monitor. “The pulse
oximeter 10 may be configured to provide an active audible alarm
with at least two distinctive tones.” Mannheimer 113. Mannheimer
teaches using two separate speakers that are spatially separated. See
id. 114. The speakers may be built in speakers or remote speakers.
See id. 116.
5 Final Office Action mailed April 6, 2016 (“Final Act.”).
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FF2. Mannheimer teaches setting alarm condition for “low battery, high or
low oxygen saturation, high or low pulse rate, sensor disconnect, high
patient temperature, high or low blood pressure, and so forth.” id.
116.
FF3. Mannheimer teaches that alternatively “alarms are visually and/or
haptically indicated in addition to being audibly indicated. Indeed,
alarms may be indicated to alert any of a caregiver’s senses (e.g.,
sight, touch, and hearing). These alternative sensory indications (e.g.,
alarm lights and vibrating pagers) are additional tools with which a
user’s attention can be directed to an alarm condition.” id. 120; see
Ans. 3.
FF4. Mannheimer teaches increasing the volume of the audible sound when
the alarm has not been acknowledged. “The reminder tone is sounded
after the alarm condition has remained unacknowledged for a
designated amount of time. In another embodiment, distinctive
reminder tones are sounded alternatively from the respective speakers
12 and 14, thus creating increasing audio agitation (e.g., increasing
volume, frequency, and/or dissonance) after a designated amount of
time has passed without the alarm condition having been
acknowledged by pressing an alarm silence button 16.” Mannheimer
113; see also id. 117 (“attract the attention of users by elevating
annoyance levels of the alarm sounds”).
FF5. Mannheimer teaches communicating the urgency of an unanswered
alarm by increasing the annoyance level of the alarm. “[Gradually
increasing communicated urgency, distinguishing features (e.g., type
of sound), and/or the annoyance level of the alarm.” Id. 124; see also
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129 (“audible alarm system 96 may emit audible alarm tones with
increasingly annoying characteristics”); see Ans. 3.
FF6. Smith teaches that “patient alarms are configured to sound a local
alarm and to also transmit an alarm signal (either wirelessly or via
wiring) to a remote location such as a nurses’ station.” Smith 145;
see Ans. 4 & 8.
FF7. Smith teaches a system that automatically suppresses an audible alarm
when the caregiver is in proximity to the physiological monitor.
[I]f an alarm situation arises while the caregiver is in the
room, in the preferred embodiment no audible alarm will
be sounded, although a visual alarm and/or a remote
alarm might still be utilized. Obviously, exactly how this
particular aspect will be implemented is a design choice
that is well within the abilities of one of ordinary skill in
the art. In some circumstances, the opposite function
might be provided, i.e., if a new patient condition that
warrants an alarm arises while the caregiver is in the
room, only such new alarms will be sounded. In other
instances, only certain kinds of new alarm conditions will
be suppressed, e.g., a cardiac alarm might sound audibly
if a change in the patient’s condition calls for it while the
caregiver is present, whereas a bed or other exit alarm
might not be sounded.
Smith 148 (emphasis added); see Ans. 4 & 8.
FF8. Smith alternatively teaches manually engaging the suppressing pulse
when caregiver enters the room. “[T]he badge 410 will be equipped
with a deactivation switch or button (which might be the same
physical button as was used to activate the transmitter) to allow the
caregiver to manually terminate the broadcast of the inhibiting signal
while still in the patient’s room.” Smith | 52; see Ans. 8—9.
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FF9. Williams teaches that alarms may be color coded based on severity.
More generally in relation to system alarms, the
expert system may give a warning to the user when an
alarm limit for any parameter is exceeded, by an alarm
tone graded according to severity, a visual alarm
message colour coded according to severity or by
flashing a visual alarm message for a particular
parameter, for example. Alarms can be indefinitely
suspended for 1, 2 or 3 minutes, after which the alarm
will automatically reactivate. In the preferred form unit
to prevent unwanted alarms, the parameters which will
trigger an alarm may be entered by the clinician. Alarms
may be graded and prioritised for example as red alarms
to indicate a critical situation occurring; yellow alarms to
alert clinicians when alarm limits are exceeded; and
technical alarms which are triggered by signal quality
noise and problems, and equipment malfunction.
Williams 7:26-41 (emphasis added); see Ans. 4.
Principle of Law
“If the claim extends to what is obvious, it is invalid under § 103.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007).
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same reason,
if a technique has been used to improve one device, and a person
of ordinary skill in the art would recognize that it would improve
similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill.
Id. at 417. It is proper to “take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” Id. at 418; see also
id. at 421 (“A person of ordinary skill is also a person of ordinary creativity,
not an automaton.”).
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Analysis
Mannheimer teaches using a physiological monitor that is able to
sound an audible alarm that drives two separate speakers that are spatially
separated. FF1. Mannheimer’s monitor is programmed to sound the alarm
for a variety of conditions including low oxygen and low pulse. FF2. In
addition to audible alarms, Mannheimer also teaches the use of visual or
haptic alarm indicators. FF3. Mannheimer teaches escalating the annoyance
level of an alarm if the there is no response to the initial alarm. FF4 & FF5.
Smith teaches sounding an alarm at the bedside monitor as well as at a
remote location such as a nurse’s station. FF6. Smith teaches automatically
suppressing an audible alarm at the bedside when the caregiver is in the
room. FF7. In other embodiments, Smith teaches requiring caregiver input
in the form of manually activating a suppressing signal when entering the
room to end the alarm. FF8. Thus, Smith’s system can be programmed to
either automatically send an alarm inhibiting signal or requiring manual
activation of the inhibiting signal by the caregiver. FF7 & FF8.
Williams teaches grading the alarm condition by applying color codes
based on the severity of the patient’s condition. FF9.
Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that it would have been obvious to an ordinary
artisan of ordinary creativity to arrive at an alarm system that “is configured
to override the alarm silencing setting based on an alarm urgency.” Here,
Smith expressly teaches that “a cardiac alarm might sound audibly if a
change in the patient’s condition calls for it while the caregiver is present.”
FF7. In other words, Smith teaches overriding the alarm suppressing signal
when the patient’s condition by the system is assessed to be critical. This
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teaching meets the express limitation “configured to override the alarm
silencing setting based on an alarm urgency” as recited in claim 1.
Appellants contend that “the combination of Mannheimer, Smith, and
Williams fails to teach overriding an alarm silencing setting based on alarm
urgency, either manually or automatically.” Reply Br. 7; see also Appeal
Br. 8 (“fail to teach a processor configured to override an alarm silencing
setting based on an alarm urgency’'’). Specifically, Appellants contend,
Mannheimer and Smith “fail[] to teach or suggest at least overriding an
alarm silencing setting based on alarm urgencyReply Br. 6. While
“Williams may automatically determine alarm urgency, Williams does not
teach automatically overriding an alarm silencing setting based on alarm
urgency. . . . Williams reactivates all suspended alarms in the same manner
regardless of the urgencies of the alarms.” Reply Br. 6; see also Appeal Br.
8 (“Williams does not override any alarms contingent on their urgency but,
instead, always reactivates alarms in the same manner, regardless of the
severity of the alarm.”).
We begin with claim construction of the phrase “configured to
override the alarm silencing setting based on an alarm urgency,” giving the
claims their broadest reasonable interpretation consistent with the
Specification. In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000); see also In
re Am. Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Therefore, we first turn to the Specification to determine if the meaning of
the phrase “configured to override the alarm silencing setting based on an
alarm urgency” can be discerned.
The Appeal Brief identifies paragraph 22 of the Specification as
disclosing this limitation, specifically, showing that “[t]he physiological
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monitor is configured to override the alarm silencing setting based on an
alarm urgency.” Appeal Br. 3. Paragraph 226 of the Specification teaches
using a button to acknowledge the sounding of an alarm. “[A] user presses
an acknowledge button that silences the alarm and indicates that the alarm
has been acknowledged.” Spec. 13. The Specification provides that “[a]fter
an alarm has been initiated (block 114 [of Fig. 4(not shown)]), the method
108 begins determining whether the alarm condition still exists and/or
whether the alarm signal has been acknowledged in block 116. .. . If the
bedside alarm has been acknowledged, the method may return to start 110.”
Spec. 122. The Specification also provides that “the alarm silence may be
overridden when the alarm is escalated.” Spec. 118.
The broadest reasonable interpretation of the “configured to override
the alarm silencing setting based on an alarm urgency” as read in light of the
Specification encompasses escalating an alarm based on an initial alarm
condition that is not acknowledged based on the continuing condition of the
patient. In other words, this is reasonably interpreted to encompass an alarm
that goes from an initial silent alarm setting to an audible alarm.
The Examiner recognizes that Mannheimer does not exemplify
inaudible alarms, but finds that this would nevertheless have been obvious
because the reference teaches escalating an alarm from a quieter to a louder
setting. See Final Act. 3. Mannheimer therefore teaches overriding a prior
alarm setting by escalating the alarm sound when the alarm is not
acknowledged; this is reasonably interpreted to meet the limitation of
overriding an alarm setting. See FF4 & FF5. Based on Mannheimer’s
6 We note that the Specification filed on June 30, 2008, contains two
paragraphs labeled 22. See Spec. 12 & 13.
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teaching, the Examiner finds that it would have been obvious to “modify
Mannheimer’s system to first trigger an inaudible alarm such as visual or
haptic alarm, and then escalate to audible alarms.” Final Act. 3. We agree
with the Examiner that it would have been obvious to modify Mannheimer’s
system to include an inaudible alarm setting at the physiological monitor
location, especially when considered in light of the teaching of Smith that
silences the alarm when the caregiver is in close proximity to the patient.
FF7.
The Examiner also recognizes that “Smith explicitly teaches a patient
monitor which automatically ceases an audible alarm upon confirmation of a
caregiver’s badge within the vicinity to the patient monitor ([0046-48]).
And depending on the nature of the alarm, i.e. alarm setting, the silencing of
the alarm will be overrid [den].” Ans. 8 (italics in original); see FF7.
Specifically, Smith explains that “only certain kinds of new alarm conditions
will be suppressed, e.g., a cardiac alarm might sound audibly if a change in
the patient’s condition calls for it while the caregiver is present, whereas a
bed or other exit alarm might not be sounded.” FF7. Thus, Smith already
teaches overriding an alarm silencing based on urgency. Advisory Act. 27;
see Ans. 8.
The Examiner also cites Smith’s teaching of manually silencing an
alarm based on the caregiver assessing the patient’s condition (see FF8),
concluding that it would be obvious to automate a manual activity. See Ans.
7 (citing In re Venner, 262 F.2d 91, 95 (CCPA 1958)). Appellants contend
that “[i]n contrast to In re Venner, . . . the cited combination does not yield
7 Advisory Action mailed June 18, 2015 (“Advisory Act.”).
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all of the elements of the claims at issue.” Reply Br. 4. We are not
persuaded by Appellants’ contention regarding missing elements. As
discussed above Smith discloses that the alarm silence setting can be
overridden if the patient’s condition changes so that an audible alarm is
warranted. FF7 (“a cardiac alarm might sound audibly if a change in the
patient’s condition calls for it while the caregiver is present”). Thus,
Smith’s patient monitor is already performing the alarm urgency
determination. FF7.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting the prima facie case.
As Appellants do not argue the other claims separately, claims 2, 6, 7, and
16-31 fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of all claims.
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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