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 .
DETAILED ACTION
This action is in reference to the communication filed on 18 MAY 2026.
Amendments to claims 1, 8, 15, the cancellation of claims 2, 4, 5, 9, 11, 12, 16, 18, 19 are entered.
Claims 1, 3, 6-8, 10, 13-15, 17, 20, 21 are present and have been examined.
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, 3, 6-8, 10, 13-15, 17, 20, 21 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1, 3, 6-8, 10, 13-15, 17, 20, 21 the independent claim(s) 1, 8, 15 recite an apparatus and a method, and a non-transitory computer readable medium, each of which fall into a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1, 3, 6-8, 10, 13-15, 17, 20, 21, the independent claim(s) (claims 1, 8, 15) is/are directed, in part, to:
An
an
dynamically estimate an error threshold specific to a medical condition of a patient based on existing patient data in the electronic medical record database and the monitored plurality of parameters of the patient, the error threshold including an upper bound and a lower bound, and
determine whether supplemental entry of current patient data is needed based on the existing patient data in the
wherein the dynamic estimation of the error threshold comprises (i) detecting a change in a medical condition of the patient based on the analysis of the existing patient data and the monitored plurality of parameters of the patient, (ii) determining, based on the change in the medical condition of the patient, that the upper bound is no longer reliable for detecting an error in the existing patient data, (iii) measure by the patient monitor, one or more parameters of the monitored plurality of parameters of the patient and re-establish the medical condition of the patient, and (iv) calculate an upper bound based on the measured parameters and re-established medical condition of the patient; and
an
wherein for the determination that at least a portion of the existing patient data is stale based on a recurring fixed time, the one or more patient data queries; and wherein the determination that at least a portion of the existing patient data is stale based on the obtained one or more settings for the recurring fixed timer
wherein for the determination that at least a portion of the existing patient data is stale based on an error threshold, the
The non-strikethrough limitations common to claims 1, 8, 15 are considered to be abstract ideas as they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Parsing a record, determining if supplemental information is needed, and notifying supplemental information is required based on a set of criteria are all examples of such concepts. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
The non-strikethough limitations common to claims 1, 8, 15 are also considered to be abstract ideas as they are directed to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The process identified in these claim(s) outlines a series of steps of managing the patient information as communicated between a patient and a care provider role, based on predefined criteria. If a claim limitation under its broadest reasonable interpretation covers managing personal behavior or relationships then it falls within the “method of organizing human activity” grouping of abstract idea(s)
Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements – the records common to all are “electronic” medical records, stored in a “database”, and a notification is sent to a “user interface” associated with the provider, with claims 1, 8, 15 further reciting a non-transitory machine readable storage medium comprising instructions, a processor, and in the interest of compact prosecution, a patient monitor configured to monitor a patient. Examiner finds that the “electronic” medical records, the “database” and the “user interface”, as well as the machine readable storage medium comprising instructions, and processor recite no improvement to the functioning of the computer or any other technology or technical field as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). Similarly, Examiner finds the patient monitor at best to be an application of a technology – (Examiner notes that as claimed, the monitor could be another person watching the patient – no sensor or other hardware is present). Examiner finds that the transmission or sending of data, between the database and the user interface, is at best analogous to adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g). The identified elements, including the computing elements of claim 15, are recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer/processor, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: the records common to both independent claims are “electronic” medical records, stored in a “database”, and a notification is sent to a “user interface” associated with the provider, with claim 1 reciting a processor, and 15 further reciting a non-transitory machine readable storage medium comprising instructions, a processor, and in the interest of compact prosecution, a patient monitor. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0031] In the illustrated implementation, the electronic medical record database 102 may include one or more types of patient data. For example, the electronic medical record database 102 may include laboratory result data 104, microbiology data 106, medication data 108, vital sign data 110, care order data 112, admission discharge and transfer data 114, the like, and/or combinations thereof.
[0034] In the illustrated implementation, the EMR management system 100 may also include an interface engine 120. The electronic medical record parser 122 may be coupled to the electronic medical record database 102 via the interface engine 120. In such an implementation, the patient data from the electronic medical record database 102 may be received through an EMR Application Programming Interface (EMR API). For example, the patient data from the electronic medical record database 102 may be received through the EMR API in a Fast Healthcare Interoperability Resources (FHIR) protocol. In such an implementation, the interface engine 120 may include a FHIR engine.
[041] …The electronic medical record parser 122 may parse the electronic medical record database 102 for relevant patient data corresponding to the one or more patient data queries. The electronic medical record parser 122 may return the relevant patient data from the electronic medical record database 102 to the one or more clinical decision support applications 136.
Examiner, solely in the interest of compact prosecution, makes reference to:
[0047] In an example, the patient monitor 202 may be utilized to enter patient data to the electronic medical record database 102. For example, the patient monitor 202 may determine measured patient data. In such an example, the patient monitor 202 may be configured to monitor a patient for vital signs and the like, and the patient monitor 202 may communicate such measured patient data to the electronic medical record database 102.
[0096] FIG. 7 shows an illustrative example of the EMR management system 100. In the illustrated example, the EMR management system 100 may include a processor 702 and a memory 704 communicatively coupled to the processor 702. The memory 704 may include logic 706 as a set of instructions. In some implementations the logic 706 may be implemented as software. In an embodiment, the logic 706, when executed by the processor 702, implements one or more aspects of the method 300 (FIG. 3), the method 400 (FIG. 4), and/or realize the EMR management system 100 (FIG. 1), already discussed.
[0097] In some implementations, the processor 702 may include a general purpose controller, a special purpose controller, a storage controller, a storage manager, a memory controller, a micro-controller, a general purpose processor, a special purpose processor, a central processor unit (CPU), the like, and/or combinations thereof.
[0099] In some examples, the memory 704 is an example of a computer-readable storage medium. For example, memory 704 may be any memory which is accessible to the processor 702, including, but not limited to RAM memory, registers, and register files, the like, and/or combinations thereof. References to “computer memory” or “memory” should be interpreted as possibly being multiple memories. The memory may for instance be multiple memories within the same computer system. The memory may also be multiple memories distributed amongst multiple computer systems or computing devices.
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. Examiner notes that the identified elements are recited in functional terms only. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2, 3, 6, 7, 10, 13, 14, 17, 20, 21:
Dependent claims 2, 3, 6, 7, 10, 13, 14, 17, 20, 21 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as the types of information missing and what constitutes missing information, when information is determined to be missing, and additional means of parsing data. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention. Examiner notes that claims 3, 6, 7, 10, 13, 14 nominally recite the use of an “application” – as currently claimed Examiner does not find this to constitute an additional element, however in the interest of compact prosecution Examiner refers again to Applicant’s specification at [0034] which explains the application type itself is merely applied to the abstract idea rather than improved upon in any meaningful way, and as such is ineligible to support a finding of significantly more.
Non-Obvious Subject Matter
1, 3, 6-8, 10, 13-15, 17, 20, 21 are believed to be free of the prior art. The closest prior art of record is believed to be:
Gnanasambandam et al (US 20230082381 A1, hereinafter Gnanasambandam)
Boston et al (US 20160019347 A1, hereinafter Boston).
McNair et al (WO 2015023674, hereinafter McNair)
Gnanasambandam teaches parsing electronic medical records to determine if additional or supplemental record information is needed from the patient, based on a determination that the existing or stored data is in some way insufficient or incorrect, and provides an interface to alert a provider to this and correct or collect the required supplemental/replacement information. The reference also provides an opportunity for manual correction on the part of the provider interacting with the user interface and collecting the information.
Boston also teaches parsing medical records, and considers that routine updates are required on a set scheduled interval in order to keep information from becoming “stale,” expired or otherwise outdated, and when such a condition is detected a prompt for supplement information is automatically generated for the user.
McNair discloses a means of parsing data to determine a clinical condition of a user via EHR documents, and from the information making an inference about the user and the validity of the data contained within the EHR for a given patient. The conclusions of the extraction process are used to validate the original EHR record data.
However, the references when taken separately or in combination do not fairly disclose the amended limitations that clarify and narrow the situation in which the data is found to be stale and or otherwise deficient, in order to require the updated/supplemental information be collected. That the settings for the information refresh are incorporated is found to overcome the prior art of record.
The Examiner hereby asserts that the totality of the evidence neither anticipates nor renders obvious the particular combination of elements as claimed. That is, the Examiner emphasizes the claims as a whole and hereby asserts that the totality of the evidence fails to set forth, either explicitly or implicitly, an appropriate rationale for combining or otherwise modifying the available prior art to arrive at the claimed invention. The combination of features as claimed would not be obvious to one of ordinary skill in the art because any combination of the evidence at hand to reach the combination of features as claimed would require a substantial reconstruction of Applicant’s claimed invention relying on improper hindsight bias.
Response to Arguments
Applicant’s remarks as filed on 18 MAY 2026 have been fully considered.
Applicant turns to the rejection under 35 USC 101 of claims 1, 3, 6-8, 10, 13-15, 17, 20, 21 on page 11, with elements of USPTO guidance regarding subject matter eligibility into page 12. Applicant reproduces exemplary claim 1 into page 13, and concludes that the human mind is not equipped to perform these limitations. Examiner respectfully disagrees – a human mind can of course receive information about monitored signals, and conclude an estimated error threshold based on changing values. Applicant’s remarks regarding a “parser” are better suited to subsequent steps of the analysis.
Applicant turns to a discussion of the practical application step of the analysis on page 14. Applicant alleges that an improvement to patient monitoring is found, and that the field of patient monitoring is itself technical. Examiner respectfully disagrees – while the claimed solution is perhaps technical in nature, and perhaps improves the field of patient monitoring, the field itself is not technical nor are the improvements themselves technical. Providing a means of calculating a threshold is not itself technical for the purposes of the analysis, nor is using an error threshold to determine a change in a patient’s condition.
Applicant tuns to step 2B on page 15. Applicant’s remarks are conclusive at best, and do not explain what exactly is alleged to be the inventive concept beyond what is well understood routine and conventional.
Applicant’s remarks regarding the remaining claims on pages 15/16 are found moot in view of the discussion above.
Applicant’s remarks regarding the prior art are noted on page 16.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
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