DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-6, 8-9, 11-18, 20-21, 23-30, 32-33 and 35-36, as filed 10/27/2025, are currently pending and have been considered below.
Priority is generally acknowledged as shown on the filing receipt with the earliest date being 07/07/2022.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon and the rationale supporting the rejection would be the same under either status.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8-9, 11-18, 20-21, 23-30, 32-33 and 35-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 1-6, 8-9, 11-18, 20-21, 23-30, 32-33 and 35-36 do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 13-18, 20-21, and 23-24 do not recite statutory subject matter within a statutory category because the computer program product includes transitory storage media such as signals per se. MPEP 2106.03: “Non-limiting examples of claims that are not directed to any of the statutory categories include:… Transitory forms of signal transmission (often referred to as “signals per se”), such as a propagating electrical or electromagnetic signal or carrier wave.” The claims are further analyzed under 101 assuming, arguendo, that the program product comprised only non-transitory computer readable media.
Claims 1-6, 8-9, 11-12, 25-30, 32-33, and 35-36 recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
1. A computer-implemented method, executed on a computing device, comprising:
monitoring a device to receive data signals indicative of the device (additional element – apply the abstract idea with a computer and insignificant extra-solution activity);
comparing the data signals to defined signal norms to identify outliers (mental process);
investigating the outliers to determine if an issue exists with the device (mental process); and
adjusting outlier definition criteria to eliminate the outlier if an issue does not exist (mental process);
including defining bespoke outlier definition criteria for the device, wherein defining bespoke outlier definition criteria for the device includes: processing the data signals over a defined period of time and iteratively redefining the signal norms based upon updated data signals received from the device (mental process because processing data signals and iteratively redefining them can be performed mentally; mathematical concept; to the extent that this processing uses a computer it is merely applying the abstract idea with a computer).
2. The computer-implemented method of claim 1 wherein the outlier definition criteria includes signal thresholds (mental process).
3. The computer-implemented method of claim 1 wherein the data signals concern one or more details of the device and/or uses of the device (additional element – apply the abstract idea with a computer).
4. The computer-implemented method of claim 1 wherein the device includes one or more of: a medical device, a process control device, a networking device, a computing device, a manufacturing device, an agricultural device, an energy / refining device, an aerospace device, a forestry device, and a defense device (additional element – apply the abstract idea with a computer).
5. The computer-implemented method of claim 1 wherein the defined signal norms include user-defined signal norms (mental process).
6. The computer-implemented method of claim 1 wherein the defined signal norms include machine-defined signal norms (additional element – apply the abstract idea with a computer).
8. The computer-implemented method of claim 6 wherein the machine-defined signal norms are compartmentalized (e.g., gender, race, age, location, device type, device class, seasonality, time of day, etc.) (additional element – apply the abstract idea with a computer).
9. The computer-implemented method of claim 1 wherein investigating the outliers to determine if an issue exists with the device includes one or more of:
examining other data signals from the device (abstract idea – mental process).
11. The computer-implemented method of claim 1 further comprising: addressing the issue if the issue does exist (abstract idea – certain methods of organizing human activity and abstract idea).
12. The computer-implemented method of claim 1 wherein the device includes one or more sub devices (additional element – apply the abstract idea with a computer).
The reasoning from these claims applies to the other analogous claims.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the broadest reasonable interpretation of many claim limitations includes steps that a human could perform by thinking about a patient and device readings. But for the generic computer language, adjusting an outlier definition criteria amounts to a human clinician making a mental note such as that a particular patient’s spO2 typically runs low and is not a true problem. Similarly, processing data signals and iteratively redefining them can be performed mentally and is also a mathematical concept.
The dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims as described above. For example, claim 8 recites particular aspects of how mental determination is made but for recitation of generic computer components.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, monitoring a device to receive signals indicative of the device amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0039]-[0041] which generally describe the broad classes of computing and monitoring devices with which the information management system and method can be implemented, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, monitoring a device to receive signals indicative of the device amounts to mere data gathering and selecting a, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claim 4 recites various types of devices but is broad enough to include generic computers and thus amounts to applying the abstract idea with a computer. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception or add insignificant extra-solution activity to the abstract idea such as mere data gathering which is similar to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6, 8-9, 11-18, 20-21, 23-30, 32-33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (USP App. Pub. No. 2019/0295696) in view of Al-Ali (US20110213212A1).
Regarding claim 1, Yang discloses: A computer-implemented method, executed on a computing device, comprising:
--monitoring a device to receive data signals indicative of the device (“According to an embodiment, the patient sensor communicates with a patient monitor 18 via a wired and/or wireless communications link. Accordingly, both the patient sensor and the patient monitor 18 can comprise a communications module 16 to facilitate the wired and/or wireless communications between the patient sensor and the patient monitor,” [0035]; collect information about patient 320 in FIG. 3; monitor patient 510 in FIG. 5);
--comparing the data signals to defined signal norms to identify outliers (“If an upper or lower alarm limit is exceeded the system may produce an alarm, which may be an audible, visible, and/or haptic alarm, among other possible alarms. The alarm may be duplicated on or limited to central monitoring stations, sent to care provider smart phones or pagers, etc,” [0037]; “Many deterioration detection algorithms set pre-defined or pre-determined criteria and thresholds. When a monitored risk indicator passes pre-defined or pre-determined criteria or thresholds, an alarm can be generated,” [0002]);
--investigating the outliers to determine if an issue exists with the device (“At step 360 of the method, according to an embodiment, the one or more alarm setting recommendations for the patient are communicated to a user such as a health care provider, and the user accepts and/or inputs the recommendations to a patient monitor 18 and/or central monitoring system 200,” [0049]; “At step 550 of the method, the user can accept or modify the one or more recommendations. For example, the user can accept all the recommendations with a single click. Alternatively, the user may have the option to “MODIFY” in which the user can edit a particular setting and accept the rest of the recommended settings. For example, the patient monitor may present one or more generated recommendations, such as a suite of recommendations, to the health care provider who can then accept the suite of recommendations or can modify one or more of the generated recommendations,” [0061]); and
--adjusting outlier definition criteria to eliminate the outlier if an issue does not exist (accept and/or input the generated recommendations 360 in FIG. 3; 550 and 560 in FIG. 5; “Applied to a patient monitoring system configured to provide customized alarm settings to a health care provider, the inventive methods and systems encourage health care providers to use customized patient monitoring settings, and as a result reduces alarm load and alarm fatigue in the clinical setting. The patient monitoring system can also utilize input from health care providers in order to learn and improve the accuracy of customized settings and recommendations,” [0004]; “the method further includes the step of updating, using the input from the user regarding the one or more alarm setting recommendations, the alarm setting recommendation classifier,” [0017]),
Yang does not expressly disclose but Al-Ali teaches:
--including defining bespoke outlier definition criteria for the device, wherein defining bespoke outlier definition criteria for the device includes: processing the data signals over a defined period of time and iteratively redefining the signal norms based upon updated data signals received from the device (“for a lower limit embodiment, an adaptive alarm system adjusts an alarm threshold downwards when a parameter baseline is established at lower values. Likewise, for an upper limit embodiment, the adaptive alarm system adjusts an alarm threshold upwards in accordance with baseline drift so as to avoid nuisance alarms,” [0011]; “the baseline processor has a sliding window that identifies a time slice of parameter values. A trend calculator determines a trend from an average of the parameter values in the time slice. A response limiter tracks only the relatively long-term transitions of the trend. A bias calculator deletes the highest parameter values in the time slice or the lowest parameter values in the time slice so as to adjust the baseline to either a lower value or a higher value, respectively. The adaptive threshold becomes less response to baseline drift as the baseline approaches a predefined parameter limit,” [0013]).
It would have been obvious before the effective filing date to one of ordinary skill in the art to include the adaptive threshold updating of Al-Ali within the patient monitoring system of Yang because this would “solve false alarm and missed true alarm problems associated with baseline drift,” (Al-Ali [0011).
Regarding claim 2, Yang discloses: wherein the outlier definition criteria includes signal thresholds (“Many deterioration detection algorithms set pre-defined or pre-determined criteria and thresholds. When a monitored risk indicator passes pre-defined or pre-determined criteria or thresholds, an alarm can be generated,” [0002]; “the Tele-ICU RN registers a new patient into the central monitoring system and manually changes two alarm thresholds: the heart rate upper threshold to 120 and the SpO2 lower threshold to 88%,” [0051]; more thresholds in [0053]-[0054]).
Regarding claim 3, Yang discloses: wherein the data signals concern one or more details of the device and/or uses of the device (“Many deterioration detection algorithms set pre-defined or pre-determined criteria and thresholds. When a monitored risk indicator passes pre-defined or pre-determined criteria or thresholds, an alarm can be generated,” [0002]; “the Tele-ICU RN registers a new patient into the central monitoring system and manually changes two alarm thresholds: the heart rate upper threshold to 120 and the SpO2 lower threshold to 88%,” [0051]; more thresholds in [0053]-[0054]).
Regarding claim 4, Yang discloses: wherein the device includes one or more of: a medical device, a process control device, a networking device, a computing device, a manufacturing device, an agricultural device, an energy / refining device, an aerospace device, a forestry device, and a defense device (“the patient sensor can be a sensor or other suitable medical device such as a therapy device. For example, patient sensor 14 can be any heart rate sensor, breathing sensor, blood pressure sensor, blood oxygen saturation sensor, neurological sensor, blood glucose sensor, temperature sensor, or any other type of sensor. Patient sensor 14 can also be a therapy device such as a respirator or any other type of therapy device,” [0034]).
Regarding claim 5, Yang discloses: wherein the defined signal norms include user-defined signal norms (“configured to recommend customized alarm settings to a health care provider, and to utilize feedback in order to improve future recommendations,” [0033]; “Patient monitor 18 may also comprise a user interface 20, which can be configured to receive input from a health care provider regarding one or more settings for the monitoring system,” [0036]; [0042]; “For example, the Tele-ICU RN registers a new patient into the central monitoring system and manually changes two alarm thresholds: the heart rate upper threshold to 120 and the SpO2 lower threshold to 88%,” [0051]).
Regarding claim 6, Yang discloses: wherein the defined signal norms include machine-defined signal norms (“When a monitored risk indicator passes pre-defined or pre-determined criteria or thresholds, an alarm can be generated,” [0002]).
Regarding claim 8, Yang discloses: wherein the machine-defined signal norms are compartmentalized (e.g., gender, race, age, location, device type, device class, seasonality, time of day, etc.) (“These settings are based on the patient's demographics such as age, sex, etc., and/or on the patient's diagnosis, condition, and/or medical history,” [0051]; [0052]; “As just one example, a SpO2 greater than 95% is considered normal for the general population, but patients with stable COPD often have lower baseline SpO2. The goal of long-term treatment of stable COPD is to maintain SpO2>90%, and in this case using the same SPO2 threshold for all patients would either miss deterioration in the general patient population or cause too many false alarms in COPD patients,” [0030]).
Regarding claim 9, Yang discloses: wherein investigating the outliers to determine if an issue exists with the device includes one or more of: physically investigating the outliers; and examining other data signals from the device (“the display 22 may show physiological data and/or other data received from patient sensor 14, among other data,” [0036]; [0037]).
Regarding claim 11, Yang discloses: addressing the issue if the issue does exist (snoozing the alarmin [0037] is a form of addressing the issue).
Regarding claim 12, Yang discloses: wherein the device includes one or more sub devices (central monitor with sub-devices in [0041]-[0042]).
Claims 13-18, 20-21, and 23-23 are substantially similar to claims 1-6, 8-9, and 11-12 and are rejected with the same reasoning.
Claims 25-30, 32-33, and 35-36 are substantially similar to claims 1-6, 8-9, and 11-12 and are rejected with the same reasoning.
Response to arguments
Applicant's arguments filed 10/27/2025 have been fully considered and are discussed below.
The rejections under 112(b) are withdrawn in light of claim amendments.
Regarding the subject matter ineligibility rejections, Applicant generally argues that the claimed invention is not directed to a mental process (Step 2A Prong One) or is a practical application (Step 2A Prong Two). Remarks pages 7-8. The Examiner disagrees for the reasons set forth above. In brief, the BRI of “iteratively redefining signal norms” includes a technician monitoring a device over time and updating his mental model of the patient. For example, he might learn that this patient’s blood oxygen saturation is typically below 92 so he learns not to escalate unless it drops below 88. Without technical detail on how the logic is modified, this is squarely performable in the human mind. Similarly, nothing in the specification requires that the iterative recalculation go beyond averaging or statistical norm computation, both of which are mental processes and mathematical concepts. See Specification as published [0292].
Regarding the prior art rejections, Applicant’s arguments about anticipation by Yang are moot in view of the new grounds of rejection above.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office Action (See MPEP 706.07(a)). Accordingly, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624
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