Ex Parte Tivig et al

Patent Trial and Appeal Board

Oct 23, 2017

11721762 (P.T.A.B. Oct. 23, 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.
11/721,762 06/14/2007 Gerhard Tivig 2004P03041WOUS 2975
38107 7590 10/25/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue WESTON, TIFFANY C
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
10/25/2017 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):
patti.demichele@philips.com
marianne. fox @ philips, com
katelyn.mulroy @philips .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GERHARD TIVIG and SEBASTIAN HEBLER
Appeal 2016-005460
Application 11/721,762
Technology Center 3700
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
medical monitoring system. The Examiner rejected the claims as directed to
nonstatutory subject matter, as anticipated, and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as KONINKLIJKE PHILIPS
ELECTRONICS, N.V. (see App. Br. 1).
Appeal 2016-005460
Application 11/721,762
Statement of the Case
Background
“In a clinical environment a patient monitor is used for the
observation of the condition of a patient. The primary function of a patient
monitor is to warn the clinical staff on changes in the status of the patient”
(Spec. 1:8—10). “Typically a limit alarm mechanism is implemented in such
patient monitors. Thereby an alarm is activated if a measurement exceeds a
user-defined threshold” (Spec. 1:10-12).
The Claims
Claims 4, 6, 13—20, 22, and 24—31 are on appeal. Independent claim
24 is representative and reads as follows:
24. A medical monitoring system for observing a condition
of a patient and warning medical staff of changes in a status of
the patient, the system comprising:
a plurality of sensors which acquire medical data from
the patient, the medical data being indicative of a plurality of
vital signs including heart rate, oxygen saturation and
respiration;
at least one memory configured to store the medical data;
a display device;
one or more processors configured to:
receive the medical data;
analyzing the medical data for an occurrence of
trigger conditions, the trigger conditions including the
medical data corresponding to each of the vital signs
crossing a selected threshold for a selected duration,
analyzing the trigger conditions to determine if one
or more of a plurality of event parameters are satisfied,
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each event parameter including a different predefined
combination of two or more trigger conditions,
analyzing the event parameters to determine if one
or more event groups are satisfied, each event group
including a combination of a plurality of event
parameters,
in response to one of the event groups being
satisfied, controlling the display device to display an
event notification including medical content information.
The Issues
A. The Examiner rejected claims 4, 6, 13—20, 22, and 24—31 under
35 U.S.C. § 101 as directed to nonstatutory subject matter (Final Act. 4—5).
B. The Examiner rejected claim 24 under 35 U.S.C. § 102(a)/§ 102(e) as
anticipated by Hutchinson2 (Final Act. 5—7).
C. The Examiner rejected claims 4, 6, 13, 14, 16, 18—20, 22, 25, and 27
under 35 U.S.C. § 103(a) as obvious over Hutchinson and Rosenfeld3 (Final
Act. 8-15).
D. The Examiner rejected claims 15 and 26 under 35 U.S.C. § 103(a) as
obvious over Hutchinson, Rosenfeld, and Schradi4 (Final Act. 15—17).
E. The Examiner rejected claims 17 and 23 under 35 U.S.C. § 103(a) as
obvious over Hutchinson, Rosenfeld, and Reed5 (Final Act. 17—18).
F. The Examiner rejected claims 28—31 under 35 U.S.C. § 103(a) as
obvious over Hutchinson and Schradi (Final Act. 19—22).
2 Hutchinson et al., US 2005/0020886 Al, published Jan. 27, 2005.
3 Rosenfeld et al., US 6,804,656 Bl, issued Oct. 12, 2004.
4 Schradi et al., US 5,860,918, issued Jan. 19, 1999.
5 Reed et al., US 6,524,239 Bl, issued Feb. 25, 2003.
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A. 35 U.S.C. § 101
The Examiner finds the claims “are directed to analysis of medical
data, which is directed to an abstract idea” (Final Act. 4). The Examiner
finds the “claims do not include additional elements that are sufficient to
amount to significantly more than the judicial exception because the
additional elements of a physiological data sensor, processor, memory, and
display are all generic hardware performing generic computer functions or
are insignificant extrasolution activities” (id.).
In Alice, the Supreme Court applied a two-step framework for
analyzing whether claims are patent-eligible under section 101. First, we
determine whether the claims at issue are “directed to” a judicial exception,
such as an abstract idea. Alice Corp. Pty. Ltd. v. CLS Banklnt’l, 134 S.Ct.
2347, 2355 (2014). If not, the inquiry ends. If the claims are determined to
be directed to an abstract idea, we next consider under step two whether the
claims contain an “inventive concept” sufficient to “‘transform the nature of
the claim’ into a patent-eligible application.” Id. (citation omitted).
Alice Step One
Claims 13, 20, 24, and 28 of the instant application are directed
systems and methods for monitoring patients for “user-defined trigger
conditions” that, in combination, “generate an event parameter notification
signal” (see, e.g., claim 13). The claims also recite generic sensors, display
devices, and processors configured to perform the method.
The Specification teaches “data of a number of different medical
parameters, e.g. heart rate and blood pressure, is acquired” and “any
measurement can be set up as an event parameter” (Spec. 3:12—16). The
Specification teaches “trigger conditions [are] assigned to the event
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parameters” and “up to four event parameters (e.g. heart rate, blood pressure,
respiration, . . .) with corresponding trigger conditions can[]be clustered to
an event group” (Spec. 3:19-23).
The Specification explains that using “this method different diseases
can be assigned to different event groups in a defined way. In other words
an event surveillance is provided, which allows to define event groups
expressing specific clinical situations. The user can be informed about these
groups and the user can review these events” {id. at 3:23—27).
Therefore, both the claims and Specification are directed to systems
and processes of obtaining medical information and analyzing that data to
display a particular result. No special rules or details of the computer
processors, sensors, display devices, or even algorithms are recited. We note
that “[cjlaims directed to the ‘process of gathering and analyzing
information of a specified content, then displaying the results,’ without ‘any
particular assertedly inventive technology for performing those functions,’
were held ineligible in Electric Power Grp., LLC v. Alstom S.A., 830 F.3d
1350, 1354 (Fed. Cir. 2016).” Trading Techs. Inti, Inc. v. CQG, Inc., 675
Fed. App’x 1001, 1005 (Fed. Cir. 2017).
We find the instant claims analogous to the claims held patent
ineligible in Electric Power. The claims are not limited by rules or steps that
establish how the focus of the system or methods are achieved. Instead, the
claims embrace the abstract idea of using medical data obtained by sensors
to allow users to set trigger signals and display alerts in real time. Because
the claims are directed to an abstract idea, we turn to the second step of the
Alice inquiry.
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Alice Step Two
In step two, we consider whether the elements of the claims transform
the nature of the claim into a patent-eligible application of the abstract idea.
Content Extraction & Transmission LLC v. Wells Fargo Bank, 776 F.3d
1343, 1347 (Fed. Cir. 2014). This inquiry is the search for an inventive
concept, which is sufficient to ensure that the claim amounts to significantly
more than the abstract idea itself. Id.
“Merely requiring the selection and manipulation of information . . .
by itself does not transform the otherwise-abstract processes of information
collection and analysis.” Electric Power, 830 F.3d at 1355. Appellants do
not identify any technological advance to the process of analyzing the
medical data, but simply provide a particular approach for data
manipulations (see, e.g., Spec. 6:23 to 7:2). Thus, we agree with the
Examiner that the claim limitations, analyzed alone and in combination, fail
to add “something more” to “transform” the claimed abstract idea of
manipulating sensor data to trigger and display alerts into “a patent-eligible
application.” See Alice, 134 S. Ct. at 2354, 2357.
Appellants contend the “Examiner has not made a prima facie
showing that the claims are patent ineligible under 35 U.S.C. § 101 by
providing a detailed analysis” (App. Br. 10; cf. App. Br. 14).
We find these arguments unpersuasive.
[T]he PTO carries its procedural burden of establishing a prima
facie case when its rejection satisfies 35 U.S.C. § 132, in
“notifying] the applicant. . . [by] stating the reasons for [its]
rejection, or objection or requirement, together with such
information and references as may be useful in judging of the
propriety of continuing the prosecution of [the] application.” 35
U.S.C. § 132.
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In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011). The Examiner has
properly applied and explained the Alice test, identifying the abstract idea
within the claim and finding the absence of “something more” that
transforms the abstract idea into a patent-eligible application. The
sufficiency of the Examiner’s prima facie case is not defined by the number
of words written but by whether the Examiner provides a reasoned statement
that provides the underlying rationale and supporting reasons. The
Examiner has done so here (see Final Act. 4—5; cf. Ans. 3—8).
Claim 13
Appellants contend that claim 13 “has set forth a detailed and specific
combination which sets forth the elements of an improved medical
monitoring system and not merely an abstract idea, such as a medical
monitoring system” (App. Br. 11).
We are not persuaded. The five operations listed by Appellants in the
Appeal Brief as elements of claim 13 are entirely focused on the abstract
idea of medical monitoring (see id. at 10-11). These five operations simply
involve the abstract idea of using medical data obtained by sensors to allow
users to set trigger signals and display alerts in real time. The operations do
not differ, in principle, from a physician, (1) aware of symptoms (i.e.,
physiological parameters) that require treatment, (2) observing a patient “in
real time” for symptoms, (3) analyzing the severity of the symptoms to make
a diagnosis, (4) informing the treatment team of the diagnosis and (5)
displaying the information on a medical record.6 Therefore, we are not
6 “[1] Minnie May, aged three, was really very sick. She lay on the kitchen
sofa feverish and restless, while her hoarse breathing could be heard all over
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persuaded that the combination of elements in claim 13 is anything other
than an abstract idea implemented on routine and conventional medical
equipment.
Claims 14—19
Appellants contend “claim 14 further calls for the one or more
processors to generate the event notification signals in real time. Thus,
claim 14 is more specific, more clearly does not set forth only an abstract
idea” (App. Br. 12). Appellants similarly claim the limitations of claims 15—
19 are also not drawn to abstract ideas (see id. at 12—14).
We find these arguments unpersuasive because each of the additional
limitations of claims 14—19 involves “the selection and manipulation of
information”, whether “event notification signals in real time” (claim 14),
displaying an “episode window including a time . . . [and] physiological
parameters responsible” (claim 15), programming processors “to
dynamically adopt new trigger conditions” (claim 16), including “a level of
priority” (claim 17), defining “medical context information” (claim 18), or
identifying types of triggers (claim 19). None of these information
processing or routine medical components “transform[s] the otherwise-
abstract processes of information collection and analysis.” Electric Power,
the house. ... [2] ‘Minnie May has croup all right; [3] she’s pretty bad, but
I’ve seen them worse. [4] First we must have lots of hot water . .. I’m going
to give her a dose of ipecac first of all’ . . . [5] ‘That little redheaded girl
they have over at Cuthbert’s is as smart as they make ‘em. ... I never saw
anything like the eyes of her when she was explaining the case to me.’”
Lucy Maud Montgomery, Anne of Green Gables, https://www.gutenberg
.org/files/45/45-h/45-h.htm#link2HCH0018, originally published June 1908.
Though we find this reference exemplary of the claimed steps, we do not,
however, rely upon it in our analysis.
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830 F.3d at 1355. These claims are drawn to iterations of the abstract idea
of using medical data obtained by sensors to allow users to set trigger signals
and display alerts in real time.
Claims 20, 4, 6, 22, and 25—31
Appellants contend
claim 20 sets forth additional limitations that, when considered
as an ordered combination, demonstrates a technologically
rooted solution to a problem and thus amounts to significantly
more. For example, claim 20 calls for the computer processors
to be programmed to perform five specific operations which, as
an ordered combination, are significantly more than merely
monitoring a patient.
(App. Br. 16.)
We find this argument unpersuasive because, as with claim 13
discussed above, each of the five processes recited in claim 20 (see also id.
at 15) is drawn to the selection and manipulation of medical information for
diagnosis and treatment and does not “transform the otherwise-abstract
processes of information collection and analysis.” Electric Power, 830 F.3d
at 1355.
We also find the existence of the additional limitations in claims 4, 6,
22, and 25—31 unpersuasive because the limitations also involve “the
selection and manipulation of information”, whether using mathematical or
logical operators to combine triggers (claim 4), to adapt the trigger based on
data (claim 6), to include medical data in the medical context information
(claim 22), to perform the process using the system of claim 13 (claims 24
and 28), to display trend vs. time data (claims 25 and 30), to display medical
data regarding vital signs from particular time periods (claims 26 and 29), or
to alter the analysis based on a user input device (claims 27 and 31).
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We, therefore, affirm the Examiner’s rejection of the claims as drawn
to patent-ineligible subject matter.
B. 35 U.S.C. § 102(a)/§ 102(e) over Hutchinson
The Examiner finds Hutchinson teaches
sensors which acquire medical data from the patient. . .
including heart rate, oxygen saturation and respiration ... at
least one memory configured to store the medical data ... a
display device . . . [and] processors configured to . . . receive
the medical data.
(Final Act. 6.) The Examiner also finds Hutchinson teaches processors for
analyzing the received data where "the logic is adapted to receive// a
physiologic data stream . . . further adapted to cross-reference the plurality
ofphysiologic variables with a set of logic rules’ '' (id.). The Examiner
further finds Hutchinson teaches “within each logic rule set is a plurality of
logic rules . . . these logic rules are comprised of diagnostic algorithms that
allow the plurality of physiologic variables to be correlated with a
diagnostic interpretation” (id. at 6—7). The Examiner finds Hutchinson
teaches “analyzing the event parameters to determine if one or more event
groups are satisfied” and “controlling the display device to display an event
notification” (id. at 7).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Hutchinson anticipates claim
24?
Findings of Fact
1. Hutchinson teaches a “method and apparatus for patient
physiologic monitoring is provided. The method includes receiving a real-
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time physiologic data stream from a patient. The real-time physiologic data
stream includes a plurality of physiologic variables. The method further
includes processing the plurality of physiologic variables using a rules
engine” (Hutchinson 17).
2. Figure 1 of Hutchinson is reproduced below:
FIGURE 1
Figure 1 illustrates “a patient physiologic monitoring assembly 10 . . . [that]
includes a controller 12 in communication with a plurality of patient sensors
14” (id. 118).
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3. Hutchinson teaches “patient sensors 14 and real-time
physiologic data stream 16 may encompass a wide variety of patient
monitoring physiologic characteristics/variables 17. These variables
include, but are not limited to, heart rate, arterial blood pressure, SpC>2, CO2,
respiration rate, and a variety of other patient physiologic responses”
(Hutchinson 118).
4. Hutchinson teaches “the use of a data storage device 24” {id. 1
19).
5. Hutchinson teaches “controller 12 may be utilized in
combination with a variety of interactive elements such as a display 18 and
user interface 20” {id. 118).
6. Hutchinson teaches “logic 22 is adapted to receive a
physiologic data stream including a plurality of physiologic variables 110 of
the patient. The logic 22 is further adapted to cross-reference the plurality of
physiologic variables with a set of logic rules 120” {id. 119).
7. Hutchinson teaches:
These logic rules 28 are comprised of diagnostic algorithms that
allow the plurality of physiologic variables 17 to be correlated
with a diagnostic interpretation 30. By way of example, one
physiologic variable 17 may indicate a drop in oxygen in a
patient’s blood. Another physiologic variable 17 may indicate
the level of CO2 that a patient exhales is dropping as well. A
logic rule 28 can be adapted such that these physiologic
variables 17 in combination correlate with a diagnostic
interpretation 30 indicating a reduction in a patient’s
circulation.
{Id.)
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8. Hutchinson teaches “sets of rule-based algorithms may be
classified based on an area of interest, such as a rule set which contains a
plurality of rules designed to monitor the cardiovascular system.” (id.).
9. Hutchinson teaches the “rule-based algorithm(s) are used to
generate a response at block 210. The response can be an alarm 218, an
indication of an abnormal event” (Hutchinson 130).
10. Hutchinson teaches “the views may be combined to generate an
alarm 218, or a series of alarms depending on the amount of agreement
between the rule sets” (id.).
11. Hutchinson teaches the
response or responses can then be displayed at block 212. The
responses can also be stored at block 216, such as in a record
relating to the subject or the monitoring. The stored response
can be used to later evaluate the effectiveness of the rule-based
algorithms, and/or be used to later supply data relating to the
subject.
(Id. 131.)
12. Hutchinson teaches “each facility and/or monitoring system
could include a network interface 31 that facilitates access to the network.
. . . Controller 13 could be configured to limit access to the rule-based
algorithms. For instance, only people meeting a certain predetermined
criteria may have access to the rule-based algorithms” (id. 127).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005).
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Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 8—15; FF 1—12) and agree that
the claims are anticipated by Hutchinson. We address Appellants’
arguments below.
Appellants contend: “Paragraph [0019] of Hutchinson applies rules
and sets of rules, but does not disclose analyzing for trigger conditions,
much less trigger conditions indicative of vital signs crossing a selected
threshold for a selected duration” (App. Br. 24). Appellants also contend:
even if the selected duration is zero seconds, the first of the
trigger conditions must include each of the vital signs crossing
a selected threshold, whether for an infinitesimally small
duration or longer. Setting the duration to zero does not take the
first analyzing step or the trigger conditions out of the claim.
(Reply Br. 10).
We are not persuaded. The person of ordinary skill in the art of
clinical treatment of patients would reasonably interpret the terms “alarm”
and “abnormal event” (FF 9-10) as “trigger conditions” that are associated
with changes in physiological variables such as “a drop in oxygen in a
patient’s blood” (FF 7). In order for an algorithm to trigger an “alarm” or
observe an “abnormal event”, there must necessarily be a threshold for what
constitutes an “abnormal event” and some duration of time necessarily must
have occurred. Therefore, Hutchinson, in teaching algorithms that generate
“alarms” and detect “abnormal events” necessarily and inherently has
triggers that cross a threshold for some duration. “It is well settled that a
prior art reference may anticipate when the claim limitations not expressly
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found in that reference are nonetheless inherent in it.” In re Cruciferous
Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002).
Appellants contend “[paragraph [0019] of Hutchinson does call for
applying two or more rules or sets of rules, but such rules are applied to the
monitored physiological variables 17 in the data stream 16, not to
combinations of trigger conditions” (App. Br. 24).
We find this argument unpersuasive because Hutchinson expressly
teaches to generate “a series of alarms depending on the amount of
agreement between the rule sets” (FF 10). Because each alarm is based on
separate rules, and is necessarily caused by a “trigger condition” using the
language of claim 24, Hutchinson’s teaching of a “series of alarms” is
reasonably interpreted as satisfying the requirement for a combination of
trigger conditions.
Appellants contend: “There is no description in these paragraphs of
Hutchinson of analyzing event parameters, which event parameters were
determined by analyzing trigger conditions, which trigger conditions were
determined by analyzing medical data” (App. Br. 24).
We are not persuaded. Hutchinson teaches rules to analyze
physiological variables such as oxygen or carbon dioxide levels (FF 7),
which are reasonably interpreted as medical data, to create alarms that are
reasonably interpreted as “trigger conditions” (FF 9—10). Finally,
Hutchinson teaches using these alarms for later analysis of the rules and of
the particular patient (FF 11), reasonably satisfying the analysis of “event
parameters” requirement of claim 24.
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Appellants contend “that each diagnostic interpretation is determined
by applying one or a set of rules directly to the data stream in a single, not
tiered, analysis” (App. Br. 24).
We find this argument unpersuasive because there is no requirement
for a “tiered” operation. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(“[A]ppellant[s’] arguments fail from the outset because . . . they are not
based on limitations appearing in the claims.”)
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Hutchinson anticipates claim 24.
C. 35 U.S.C. §103 over Hutchinson and Rosenfeld
The Examiner finds Hutchinson teaches “a physiological data sensor
. . . computer processors ... a first tier of hierarchical analysis . . . wherein
the rules can be pre-assigned or modified by the individual user ... in a
second tier, in response to detecting a plurality of the event notifications,
generate a group event notification” (Final Act. 8—9). The Examiner finds
Hutchinson also teaches “multiple logic sets can [be] use[d and] applied at
the same time” {id. at 9).
The Examiner acknowledges “Hutchinson is not clear on whether the
trigger could include a deviation trigger” (Final Act. 9). The Examiner finds
Rosenfeld “teaches a system for remote patient monitoring, wherein rules
are used for the detection of impending problems. The thresholds can be set
as an absolute or as a deviation” (id. ). The Examiner finds Rosenfeld
“teaches a specific type of threshold dependent on the patient, disease,
and/or setting” (id. at 10).
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The Examiner finds it obvious “to modify Hutchinson with the
thresholds of Rosenf[]eld because it is the use of a known technique to
improve similar devices in the same way” (Final Act. 10).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Hutchinson and Rosenfeld
render the claims obvious?
Findings of Fact
13. Rosenfeld teaches:
The monitoring system at each ICU bedside comprises a
monitoring system for monitoring the vital signs for the patient.
The vital sign monitoring system 450 captures vital sign data
452 and transmits that vital sign data 454 .... The processor at
the ICU processes the vital sign data for transmission and
storage purposes and transmits that information to the remote
location. Vital sign data is then loaded into the data base 458.
The data base for each individual patient is then reviewed and
process rules are applied 460 to the vital sign data. These
process rules relate to certain alarming conditions which, if a
certain threshold is reached, provides an alarm to the intensivist
on duty. The vital sign alarm 462 is then displaced to the
intensivist who can then take appropriate action. A typical type
of rule processing of the vital sign data might be if blood
pressure remains at a certain low level for an extended period of
time, or if heart rate remains high for an extended period of
time. In addition a wide range of other rules are provided
which will provide an audible alarm to the intensivist before a
critical situation is reached. In addition to the information
being provided to the alarming system for the intensivist, the
vital sign data 464 is also transmitted 466 into a database
warehouse 468.
(Rosenfeld 21:35—58).
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14. Rosenfeld teaches the “smart alarm system constantly monitors
physiologic data (collected once per minute from the bedside monitors) and
all other clinical information stored in the database” {id. at 24:44-47).
15. Rosenfeld teaches: “One family of alarms looks for changes in
vital signs over time, using pre-configured thresholds. These thresholds are
patient-specific and setting/disease-specific” (Rosenfeld 24:57—59).
16. Rosenfeld teaches: “Physiologic alarms can be based on
multiple variables. For example, one alarm looks for a simultaneous
increase in heart rate of 25% and a decrease in blood pressure of 20%,
occurring over a time interval of 2 hours” {id. at 25:5—8).
17. Rosenfeld teaches: “Alarms also track additional clinical data
in the patient database. One alarm tracks central venous pressure and urine
output, because simultaneous decreases in these two variables can indicate
that a patient is developing hypovolemia” {id. at 25:15—19).
18. Rosenfeld teaches: “For this alarm, current heart rate,
calculated each minute based on the median value over the preceding 5
minutes, is compared each minute to the baseline value (the median value
over the preceding 4 hours)” {id. at 25:1—4).
Principles of Law
“If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability.” KSRInt’l Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 8—15; FF 1—18) and agree that
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the claims are rendered obvious by Hutchinson and Rosenfeld. We address
Appellants’ arguments below.
Claims 13 and 20
Appellants contend “Hutchinson describes a non-tiered operation in
the sense that all of the logical operation sets are performed concurrently”
(App. Br. 21).
We find this argument unpersuasive. For claim 13, there is no
requirement for a “tiered” operation. See Self, 671 F.2d at 1348.
Claim 20 does recite “a first tier of a hierarchical analysis” that
involves analysis of medical data for event parameters, and a “second tier”
that involves event notifications. Claim 20 is reasonably interpreted as a
system with processors performing a method of analyzing medical data to
obtain at least two trigger conditions, user-defined threshold and a user-
defined deviation triggers. If at least two triggers are detected, the system
sends a notification (i.e. “event notification”) to the medical staff, with the
second tier analysis causing a notification to be sent to multiple people if
two notifications are generated at the same time.
Rosenfeld teaches analysis of medical data for trigger conditions that
are sent to the physician for review (FF 13). In addition, Rosenfeld teaches
alarms (i.e. thresholds) “can be based on multiple variables” and can “also
track additional clinical data” (FF 16—17). Hutchinson also teaches analysis
of “a plurality of physiologic variables” that may be “correlated with a
diagnostic interpretation” to create a “logic rule” regarding a patient’s
condition (FF 6—7). Hutchinson teaches that a plurality of rules may be
“designed to monitor the cardiovascular system” (FF 8). Hutchinson also
teaches the use of alarms based on the rules (FF 9—11). Finally, Hutchinson
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teaches that the data may be available to multiple people on a network (FF
12).
We agree with the Examiner that it would have been obvious to the
ordinary artisan to use multiple levels of analysis for the alarms because
“Hutchinson teaches rule sets (26) which are a collection of logic rules. . . .
The rule set is equivalent to the second tier wherein a group event
notification is generated based on a plurality of event notifications” (Ans.
10). Moreover, the ordinary artisan would reasonably have found it obvious
to send a group event notification for each detected medical alert to every
member of the patient’s medical team, including doctors, nurses, and other
relevant staff, to maintain continuity of care.
Appellants contend “Hutchinson does not analyze the acquired
variable 17 and generate trigger signals in response to user-defined trigger
conditions being detected. Moreover, Hutchinson does not analyze trigger
signals to generate an event parameter notification in response to detecting a
preselected combination of trigger signals” (App. Br. 21).
We are not persuaded. Hutchinson clearly teaches the use of alarms,
which are based on defined trigger conditions based on user-defined rules
(FF 7—10). Moreover, Rosenfeld also teaches the use of alarms as trigger
signals where a “family of alarms looks for changes in vital signs over time,
using pre-configured thresholds. These thresholds are patient-specific and
setting/disease-specific” (FF 15). Appellants fail to address this
combination of teachings or to explain why claim 13 is unobvious over this
combination. “Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
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Cir. 1986). In determining obviousness, furthermore, a reference “must be
read, not in isolation, but for what it fairly teaches in combination with the
prior art as a whole.” Id.
Appellants contend “Hutchinson does not capture the physiological
parameters responsible for generating the event parameter notification nor
control the display device to display medical context information regarding
the captured physiological parameters” (App. Br. 21).
We find this argument unpersuasive because Hutchinson expressly
teaches sensors that “may encompass a wide variety of patient monitoring
physiologic characteristics/variables 17. These variables include, but are not
limited to, heart rate, arterial blood pressure, SpC>2, CO2, respiration rate”
(FF 3). Moreover, Hutchinson teaches a display (FF 5) and Rosenfeld
teaches “the vital sign data 464 is also transmitted 466 into a database” (FF
13). These teachings reasonably render it obvious to display the
physiological parameter data such as the raw vital sign data that result in
“event parameter notification” along with the alarm itself. Indeed,
Rosenfeld teaches “the vital sign data is displayed in real time at the ICU
472” (Rosenfeld 21:64—65), supporting this reasoning.
Claim 16
Appellants contend: “Significant by its absence is any suggestion that
this evaluation is performed by a processor. Rather, it is submitted that this
is a mental operation in which the user, not a processor of the monitor,
determines the best balance between sensitivity and specificity” (App. Br.
22).
We find this argument unpersuasive because, to the extent that
Rosenfeld teaches performing the method manually “as a mental operation”
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as acknowledged by Appellants, it would have been obvious to employ a
computer in order “to update it using modem electronic components in order
to gain the commonly understood benefits of such adaptation, such as . . .
increased reliability, simplified operation, and reduced cost.” Leapfrog
Enterprises, Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007).
Such a modification is particularly obvious in the current fact pattern, where
the entire intent of Hutchinson is to replace manual monitoring of medical
patients with automated mles that allow continuous monitoring with more
accurate algorithmic interpretation of the underlying medical data (see
Hutchinson 12).
Claim 4
Appellants contend “Hutchinson does not teach or fairly suggest the
use of mathematical or logical operators” and “Rosenfeld was not cited as
and does not cure this shortcoming of Hutchinson” {id. at 23).
The Examiner responds “Hutchinson clearly teaches the use of logic
and diagnostic algorithms in the processing of the medical data. Using the
example spelled out in paragraph 19, it is clear that logical and/or
mathematical operators are used to create a trigger combination” (Ans. 11).
The Examiner further finds “Rosenf[]eld also uses mathematical and/or
logical operators in the smart alarms” {id.).
We find that the Examiner has the better position because Rosenfeld
teaches “patients with known coronary artery disease in a surgical ICU have
alarms set to detect either an absolute heart rate of 95 beats per minute or a
20% increase in heart rate over the baseline” (Rosenfeld 24:65—25:1
(emphasis added)). This is an express teaching of the logical operator “OR”
in use in an alarm (i.e. trigger).
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Claim 6
Appellants contend the “Examiner concedes that this limitation is not
shown by Hutchinson” and “as set forth in lines 14-15 [of Rosenfeld], once
the best balance between sensitivity and specificity has been evaluated, the
final thresholds are set. Because the final thresholds are set, it is submitted
that they are not dynamically adapted” (App. Br. 23).
The Examiner responds “Rosenf[]eld also defines thresholds that
change over time. For example, for an alarm look at heart rate, the threshold
is based on the median value over the preceding 4 hours, showing the
threshold can change based on the timing” (Ans. 10). The Examiner finds
“Rosenf[]eld teaches the thresholds can be initially selected and changed
based on patient data that yields the best balance between sensitivity and
specificity” (id.).
We find that the Examiner has the better position. As the Examiner
notes, Rosenfeld teaches that one alarm is “calculated each minute based on
the median value over the preceding 5 minutes, is compared each minute to
the baseline value (the median value over the preceding 4 hours)” (FF 18).
Because the baseline value changes based on the acquired medical data, this
exemplary embodiment of Rosenfeld teaches an alarm that is calculated by
the processor and dynamically depends on the acquired medical data,
satisfying the requirement of claim 6 (see FF 18).
In addition, as discussed above, even if Appellants correctly state that
Rosenfeld’s teaching “to determine a magnitude change for each variable
that yields a best balance between sensitivity and specificity ... is a mental
operation performed by the user and is not performed by one or more
processors,” (App. Br. 23) it would have been obvious to employ a computer
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in order “to update it using modem electronic components in order to gain
the commonly understood benefits of such adaptation, such as . .. increased
reliability, simplified operation, and reduced cost.” Leapfrog Enterprises
Inc., 485 F.3d at 1162.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Hutchinson and Rosenfeld render the claims obvious.
D. andE. 35 U.S.C. § 103(a)
Appellants do not separately argue these rejections. The Examiner
provides sound fact-based reasoning explaining why the further
combinations of Reed or Schradi with Hutchinson and Rosenfeld render the
rejected claims obvious (see Final Act. 15—18). Having affirmed the
rejections over Hutchinson and Rosenfeld for the reasons above, we affirm
these further rejections for the Examiner’s reasons, which we adopt as our
own.
F. 35 U.S.C. § 103(a) over Hutchinson and Schradi
Appellants contend:
claim 28 calls for: (1) analyzing medical data for the occurrence
of a trigger condition, (2) analyzing the trigger conditions to
determine an event parameter, (3) analyzing occurrences of the
event parameter to determine one or more event groups, and (4)
in response to one or more of the event groups being satisfied,
displaying an event notification. Hutchinson does not show this
chain of analyses. Rather, Hutchinson has sets of mles which
concurrently analyze a medical data stream.
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(App. Br. 25). Appellants contend “Schradi was cited to show monitoring
for amplitudes. However, Schradi was not asserted to and does not cure
Hutchinson’s shortcoming of failure to disclose a series of analyses
performed on the results of prior analyses” (id.).
We remain unpersuaded for the reasons given above. In addition, as
already noted, Hutchinson teaches “rule-based algorithm(s) are used to
generate a response at block 210. The response can be an alarm 218” (FF 9),
teaching the steps (1) of analyzing medical data and (2) analyzing the trigger
conditions. Hutchinson further teaches the “stored response can be used to
later evaluate the effectiveness of the rule-based algorithms, and/or be used
to later supply data relating to the subject,” thereby teaching to (3) analyze
occurrences of the event group and (4) supplying data is a type of event
notification (FF 11). Consequently, we agree with the Examiner that claims
28—31 are obvious over the teachings of Hutchinson and Schradi.
SUMMARY
In summary, we affirm the rejection of claims 4, 6, 13—20, 22, and
24—31 under 35 U.S.C. § 101 as directed to a judicial exception.
We affirm the rejection of claim 24 under 35 U.S.C. § 102(a)/
§ 102(e) as anticipated by Hutchinson.
We affirm the rejection of claims 4, 6, 13, 14, 16, 18—20, 22, 25, and
27 under 35 U.S.C. § 103(a) as obvious over Hutchinson and Rosenfeld.
We affirm the rejection of claims 15 and 26 under 35 U.S.C. § 103(a)
as obvious over Hutchinson, Rosenfeld, and Schradi.
We affirm the rejection of claims 17 and 23 under 35 U.S.C. § 103(a)
as obvious over Hutchinson, Rosenfeld, and Reed.
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We affirm the rejection of claims 28—31 under 35 U.S.C. § 103(a) as
obvious over Hutchinson and Schradi.
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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