DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/14/2026 has been entered.
Claim Status
This Office Action is in response to communications filed on 1/14/2026. Claims 1, 12 and 23 were amended. No claims were canceled. No new claims were added. Likewise, claims 1-33 remain pending for examination.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 1/06/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Title 35, U.S. Code
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action.
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 1-2, 4-12, 15-21, 23-24 and 26-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Specifically, claims 1-2, 4-12, 15-21, 23-24 and 26-33 are directed to an abstract idea without additional elements amounting to significantly more than the abstract idea.
With respect to Step 2A Prong One of the framework, claim 1 recites an abstract idea. Claim 1 includes features for " normalizing the data signals of the first device and the second device to generate a plurality of homogenized signals allowing the first device and the second device to work together"; “processing the data signals of one or more of the first device and the second device over a defined period of time to automatically define one or more defined signal norms for the data signals” " enabling adjustment of a monitoring criteria associated with the monitoring device via a computing device that is remote relative to the monitoring device.
The limitations above recite an abstract idea. More particularly, the features above recite certain methods of organizing human activity related to managing data because the features describe a process for normalizing and processing data and enabling the adjustment of a monitoring criteria via a computing device. Further, the features above recite mental processes because the features describe observations or evaluations that could be practically performed in the mind or by a human using pen and paper. Finally, the element for "normalizing" recites mathematical concepts because, when considered in view of paragraphs 82-84 of Applicant's Specification, the feature recites “normalizing data, information process 10 may transform data into a standardized format or range, which may involve adjusting the values of a dataset to a common scale”. As a result, claim 1 recites an abstract idea under Step 2A Prong One.
Claims 12 and 23 include substantially similar limitations to those included with respect to claim 1. As a result, claims 12 and 23 recite an abstract idea under Step 2A Prong One for the same reasons as stated above with respect to claim 1.
Claims 2, 4-11, 15-21, 24 and 26-33 further describe the process for selecting and monitoring and processing information and further recite certain methods of organizing human activity and/ mental processes for the same reasons as stated above. As a result, claims 2, 4-11, 15-21, 24 and 26-33 recite an abstract idea under Step 2A Prong One.
With respect to Step 2A Prong Two of the framework, claim 1 does not include additional elements that integrate the abstract idea into a practical application. Claim 1 includes additional features that do not recite an abstract idea under Step 2A Prong One. The additional features include a computer system and computer program product residing on a non-transitory computer readable medium and steps for "gathering information", "normalizing, "processing", and "adjusting criteria". When considered in view of the claim as a whole, the additional elements do not integrate the abstract idea into a practical application because the additional computing elements are generic computing components that are used as a tool to perform the recited abstract idea; the steps for "gathering information", "normalizing, "processing", and "adjusting criteria" do no more than generally link the use of the abstract idea to a particular technological environment; and the steps for "gathering information" and " adjusting criteria "are insignificant extra solution activities to the recited abstract idea. As a result, claim 1 does not include any additional elements that integrate the abstract idea into a practical application under Step 2A Prong Two.
As noted above, claims 12 and 23 include substantially similar limitations to those included with respect to claim 1. Although claim 12 further includes a computer program product residing on a computer readable medium and a processor, and claim 23 further includes a processor and memory, the additional elements, when considered in view of the claim as a whole, do not integrate the abstract idea into a practical application because the additional elements amount to no more than general computing components that are used as a tool to perform the recited abstract idea. As a result, claims 12 and 23 do not include any additional elements that integrate the abstract idea into a practical application under Step 2A Prong Two.
Claims 2, 4-11, 15-21, 24 and 26-33 do not include any additional elements beyond those included with respect to the claims from which claims 2, 4-11, 15-21, 24 and 26-33 depend. As a result, claims 2, 4-11, 15-21, 24 and 26-33 do not include any additional elements that integrate the abstract idea into a practical application under Step 2A Prong Two for the same reasons as stated above.
With respect to Step 2B of the framework, claim 1 does not include additional features amounting to significantly more than the abstract idea. As noted above, claim 1 includes additional elements that do not recite an abstract idea under Step 2A Prong One. The additional elements include a computer system, computer program product residing on a non-transitory computer readable medium and steps for "gathering information", "normalizing, "processing", and "adjusting criteria". The additional elements do not amount to significantly more than the recited abstract idea because the additional computing elements are generic computing components that are used as a tool to perform the recited abstract idea; the steps for "gathering information", "normalizing, "processing", and "adjusting criteria" do no more than generally link the use of the abstract idea to a particular technological environment; and the steps for "gathering information" and "pr9ocesing data signals" are well-understood, routine, and conventional computer functions in view of MPEP 2105.06(d)(II). Further, looking at the additional elements as an ordered combination adds nothing that is not already present when considering the additional elements individually. As a result, claim 1 does not include any additional elements that amount to significantly more than the recited abstract idea under Step 2B.
As noted above, claims 12 and 23 include substantially similar limitations to those included with respect to claim 1. Although claim 12 further includes a computer program product residing on a computer readable medium and a processor, and claim 23 further includes a processor and memory, the additional elements do not amount to significantly more than the recited abstract idea because the additional elements amount to no more than general computing components that are used as a tool to perform the recited abstract idea. Further, looking at the additional elements as an ordered combination adds nothing that is not already present when considering the additional elements individually. As a result, claims 12 and 23 do not include any additional elements that amount to significantly more than the recited abstract idea under Step 2B.
Claims 2, 4-11, 15-21, 24 and 26-33 do not include any additional elements beyond those included with respect to the claims from which claims 2, 4-11, 15-21, 24 and 26-33 depend. As a result, claims 2, 4-11, 15-21, 24 and 26-33 do not include any additional elements that amount to significantly more than the recited abstract idea under Step 2B for the same reasons as stated above. Therefore, the claims are directed to an abstract idea without additional elements amounting to significantly more than the abstract idea. Accordingly, claims 1-2, 4-12, 15-21, 23-24 and 26-33 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the monitoring device” that lacks antecedent basis;
Claim 1 recites “monitoring criteria” and “ allowing … to work together” that are indefinite and result-oriented without objective boundaries.
Claims 12 and 23 have the similar issues.
Other claims are rejected because of their dependency.
Claim Rejections - 35 USC § 103
Claim 1, 12, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Boyer
(U.S. Patent Application Pub. 2016/0093205) in view of Xue (U.S. Patent Application Pub. 2016/0287207).
Regarding claims 1, 12 and 23 (Currently Amended), Boyer teaches a computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium (Fig 5; system 200) including a processor (210) and memory (206) configured to perform operations (¶040, Fig 5; circuit modules implemented as hardware and/or software) comprising: monitoring a first device to receive data signals indicative of the device (¶043; monitoring and collecting relevant data from other medical devices with a sensor to detect occurrence of alarm signals);
wherein the first device includes a first vendor device (¶043; first medical device);
monitoring a second device to receive data signals indicative of the second device, wherein the second device includes a second vendor device (¶043; monitoring and collecting relevant data from second/other medical devices with a sensor to detect occurrence of alarm signals; Examiner interprets medical devices as first, second etc. devices);
normalizing the data signals of the first device and the second device (event data of devices) to generate a plurality of homogenized signals (collected relevance event data) may reveal a relationship allowing the first device and the second device to work together processing the data signals of one or more of the first device and the second device (¶055; analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may. Include combining alarm conditions) over a defined period of time (¶025; "An alarm is generated by a medical device when alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions, Physiologic alarm conditions trigger an alarm when measured or calculated physiologic parameter satisfies an alarm condition, such as when the parameter value deviates from a threshold for a specified time) to automatically define one or more defined signal norms for the data signals (¶055; new combined alarm is not triggered when both/all conditions met, … also ¶044; new alarm protocol may be created that triggers an alarm when these identified conditions are all met at the same time).
Boyer further suggests functions for receiving data, such as physiologic data from one or more remote medical devices (¶043). But Boyer is silent on the feature: and enabling adjustment of a monitoring criteria associated with the monitoring device via a computing device that is remote relative to the monitoring device. Xue from an analogous medical devices art teaches this feature. Xue teaches a medical examination and communication apparatus wherein preference setting, operating mode, or health/symptom monitoring criteria within the medical software application can be adjusted and/or changed remotely (claim 14). Xue teaches the concept of enabling adjustment of a monitoring criteria associated with the monitoring device via a computing device that is remote relative to the monitoring device (claim 14). Therefore, it would have been obvious for one of ordinary skill in the art at the time of filing the invention to combine Boyer’s teachings with the concept of enabling adjustment of a monitoring criteria associated with the monitoring device via a computing device that is remote relative to the monitoring device, as taught by Xue in order for health/symptom monitoring criteria within a device’s medical software application to be adjusted and/or changed remotely.
Regarding claims 2, 13 and 24, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches wherein the data signals concern one or more details of the device and/or uses of the device (¶055; an initial alarm condition may trigger an alarm when oxygen saturation fails below 90%. Data analysis may show that oxygen saturation between 85% and 90% Is not clinically significant while the patient's respiration rate remains above 11 beats per minute (bpm), and may show that a drop in oxygen saturation below 90% is clinically significant at times when the patient's respiration rate is below 11 bpm… modified alarm condition may trigger an alarm when oxygen saturation is below 90% and respiration rate Is below 11 bpm… ¶045; a new alarm protocol may be created that triggers an alarm when these identified conditions are all met at the same time).
Regarding claims 3, 14 and 25, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches wherein the device includes one or more of: a medical device (¶029; a therapeutic medical device 150 according to an embodiment is illustrated in FIG. 4), a process control device (Fig 6), and a computing device (Figs 5-6).
Regarding claim 4, 15 and 26, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches wherein processing the data signals over a defined period of time to automatically define one or more defined signal norms for the data signals (see claim 23) includes: examining a range of the data signals (¶055; an initial alarm condition may trigger an alarm when oxygen saturation fails below 90%. Data analysis may show that oxygen saturation between 85% and 90% Is not clinically significant while the patient's respiration rate remains above 11 beats per minute (bpm).
Regarding claim 5, 16 and 27, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches wherein processing the data signals over a defined period of time to automatically define one or more defined signal norms for the data signals (see claim 23) includes: calculating one or more standard deviations of the data signals (¶025; comparing signals with threshold or limit).
Regarding claim 6, 17 and 28, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches wherein processing the data signals over a defined period of time to automatically define one or more defined signal norms for the data signals (see claim 23) includes: iteratively redefining the one or more defined signal norms based upon updated data signals received from the device (¶066; the medical device may be a learning device (e.g., a smart device) that adaptively modifies alarm conditions to reduce nuisance alarms and continuously updates an algorithm stored in a memory to implement the modified alarm conditions. Such an algorithm may iterate on its own modified protocols to continue to improve the protocols to reduce nuisance alarms).
Regarding claim 7, 18 and 29, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches wherein processing the data signals over a defined period of time to automatically define one or more defined signal norms for the data signals (see claim 23) includes: continuously redefining the one or more defined signal norms based upon updated data signals received from the device (¶066; continuously updates an algorithm stored in a memory to implement the modified alarm conditions).
Regarding claim 8, 19 and 30, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claim 23 and Boyer teaches the computing system of claims 1, 12 and 23 further comprising: monitoring the device to receive subsequent data signals indicative of the device (see claim 23);
comparing the subsequent data signals to the defined signal norms to identify outliers;
investigating the outliers to determine if an issue exists with the device (¶025; comparing signals with threshold or limit); and adjusting outlier definition criteria to eliminate the outlier if an issue does not exist (¶066; the medical device may be a learning device (e.g., a smart device) that adaptively modifies alarm conditions to reduce nuisance alarms and continuously updates an algorithm stored in a memory to implement the modified alarm conditions. Such an algorithm may iterate on its own modified protocols to continue to improve the protocols to reduce nuisance alarms).
Regarding claims 9, 20 and 31, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 8, 19 and 30 and Boyer further teaches 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 (Fig 9, method 330; (see ¶060-¶064; examples: ¶061; method 330 further includes assigning a relevance value (e.g., a relevance indicator) to each rated alarm event (block 336). The relevance value may be based on the relevance feedback provided by the user, ¶062; relevance value includes two values (i.e., a relevance value and an irrelevance value). For example, when the user inputs “highly relevant”, the processor may store a relevance value of 3 and an irrelevance value of 0. When the user inputs “somewhat relevant”, the processor may store a relevant value of 1 and an irrelevance value of 0. When the user inputs “somewhat irrelevant”, the processor may store a relevance value of 0 and an irrelevance value of 1... method 330 may include applying a weight to the relevance values (block 338). For example, ¶063; a weight may be a number between 0 and 2, which is applied as a multiplier to the relevance value or the irrelevance value, to adjust these values based on additional circumstances. A weight may be chosen based on several different factors. In an embodiment, one factor is the extremity of the user input
Regarding claims 10, 21 and 32, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 8, 19 and 30 and Boyer further teaches wherein adjusting the outlier definition criteria include defining bespoke outlier definition criteria for the device (¶066; Such an algorithm may iterate on its own modified protocols to continue to improve the protocols to reduce nuisance alarms).
.
Regarding claims 11, 22 and 33, Boyer and Xue teach the computing system/ computing system/computer-implemented method/ computer program product residing on a non-transitory computer readable medium of claims 1, 12 and 23 and Boyer further teaches the computing system of claim 23 wherein the device includes one or more sub devices (Fig 5; system 200 with processor 210 and memory 206; also, ¶040, Fig 5; circuit modules implemented as hardware and/or software).
Response to Arguments
Applicant’s prior art arguments to claims 1, 12 and 23 have been fully considered but are moot because the independent claim was amended by the applicant to include new features that were never previously presented. Therefore, the scope of claims 1, 12 and 23, and their dependent claims has changed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANCIL H LITTLEJOHN JR whose telephone number is (571)270-3718. The examiner can normally be reached M-F 8:30-5 (CST).
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If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Quan-Zhen Wang can be reached at (571) 272-3114. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MANCIL LITTLEJOHN JR/ Examiner, Art Unit 2685
/QUAN ZHEN WANG/ Supervisory Patent Examiner, Art Unit 2685
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