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 .
Application Status
The present communication is in response to the Amendments to the Claims and Remarks filed on 12/22/2025. Claims 1-20 are pending and addressed below. Claims 1, 10, and 16 are currently amended.
Transfer of Application
This application has been transferred within the Office as a result of Examiner Rojas leaving the office.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter). (MPEP 2106.03)
Claims 1-9 recite a series of steps, thus falling within one of the four statutory classes; i.e., a process. Claims 10-20 describe tangible system components, thus falling within one of the four statutory classes; i.e., machine or manufacture.
Step 2A, Prong One: Evaluating whether the claim(s) recite(s) a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. (MPEP 2106.04).
Representative claim 10 recites:
A system for monitoring electronic medical records (EMR) data entered into an EMR system, comprising:
a patient monitor configured to obtain information about a patient;
a user interface configured to provide output to a healthcare professional and/or to receive input from the healthcare professional; and
a processor configured to:
(i) estimate an amount of information to be entered into the EMR system during a first monitoring period, wherein the estimated amount of information to be entered into the EMR system during the first monitoring period is based at least in part on the information about the patient obtained by the patient monitor;
(ii) determine an amount of information entered into the EMR system during the first monitoring period, wherein determining further comprises determining a time of entry of the information into the EMR system;
(iii) compare the determined amount of information entered into the EMR system during the first monitoring period to the estimated amount of information to be entered into the EMR system;
(iv) determine a method of entering the data into the EMR system;
(v) estimate, based on the comparison and the determined method of entering the data into the EMR system, a likelihood of error for the information entered into the EMR system during the first monitoring period; and
(vi) assign, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from the EMR system.
The limitations of obtain information about a patient; (i) estimate an amount of information to be entered into the EMR system during a first monitoring period, wherein the estimated amount of information to be entered into the EMR system during the first monitoring period is based at least in part on the information about the patient obtained; (ii) determine an amount of information entered into the EMR system during the first monitoring period, wherein determining further comprises determining a time of entry of the information into the EMR system; (iii) compare the determined amount of information entered into the EMR system during the first monitoring period to the estimated amount of information to be entered into the EMR system; (iv) determining a method of entering the data into the EMR system; (v) estimate, based on said comparison and determined method of entering data into the EMR system, a likelihood of error for the information entered into the EMR system during the first monitoring period; and (vi) assign, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from the EMR system, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a “patient monitor”, a “user interface” and a “processor”, nothing in the claim elements precludes the steps from practically being performed in the mind.
For example, but for the a “patient monitor”, a “user interface” and a “processor” language, the functions of obtain, (i) estimate (ii) determine (iii) compare (iv) determine (v) estimate and (vi) assign, in the context of this claim encompasses a person obtaining information about a patient; (i) estimating an amount of information to be entered into the medical record (EMR) system during a first monitoring period, wherein the estimated amount of information to be entered into the EMR system during the first monitoring period is based at least in part on the information about the patient obtained; (ii) determining an amount of information entered into the EMR system during the first monitoring period, wherein determining further comprises determining a time of entry of the information into the EMR system; (iii) comparing the determined amount of information entered into the EMR system during the first monitoring period to the estimated amount of information to be entered into the EMR system; (iv) determining a method of entering the data into the EMR system; (v) estimating, based on said comparison and determined method of entering data into the EMR, a likelihood of error for the information entered into the EMR system during the first monitoring period; and (vi) assigning, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from the EMR system (e.g., a nurse obtains information about a patient, (i) based on that information, estimates how much information is expected to be entered in a patient’s chart during their shift; (ii) determines how much information is actually entered including determining a time of entry of the information; (iii) compares the expected and actual amounts of information; (iv) determines what method was used to enter the data; (v) based on said comparison, estimates how likely the information entered into the EMR system is wrong; and (vi) based on the estimated likelihood, assigns a reliability measure to the entered information or to missing EMR information).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas (Mental Processes. •concepts performed in the human mind (including an observation, evaluation, judgment, opinion)). Accordingly, the claim recites an abstract idea.
In addition, the limitations of obtain information about a patient and generate an alert indicating the likelihood of error for the information entered into the EMR system if the assigned reliability measure exceeds a threshold, as drafted, is a process that, under its broadest reasonable interpretations, exemplify relationships or interactions between people (including social activities, teaching, and following rules or instructions), but for the recitation of generic computer components.
That is, other than reciting a “patient monitor”, nothing in the claim element disqualifies the step from being managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)). For example, but for the “patient monitor” language, the steps of obtain, in the context of this claim encompasses steps of a person obtaining information about a patient from somebody else (e.g., a nurse obtains information about a patient from a medical technician who monitors patients). The step of generate an alert, in the context of this claim encompasses steps of a person sending a notification to another person when the likelihood of error exceeds a threshold.
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), then it falls within the “Certain methods of organizing human activity” grouping of abstract ideas (Certain Methods Of Organizing Human Activity. •fundamental economic principles or practices (including hedging, insurance, mitigating risk); •commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); and •managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)). Accordingly, the claim recites an abstract idea.
Independent claims 1 and 16 recite the same abstract idea as identified above and dependent claims 2-9, 11-15, 17-20 further narrow it.
Step 2A, Prong Two: Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and then evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. Prong Two distinguishes claims that are "directed to" the recited judicial exception from claims that are not "directed to" the recited judicial exception. (MPEP 2106.04).
This judicial exception is not integrated into a practical application. In particular, the claims recite the following additional elements:
electronic medical records;
a patient monitor;
a user interface;
a processor;
non-transitory computer-readable medium
The limitations of a patient monitor, a user interface, a processor and a non-transitory computer-readable medium are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. (MPEP 2106.05(f) Mere Instructions To Apply An Exception).
Although the patient monitor and user interface have been interpreted as “apply it”, a patient monitor and a user interface configured to provide output to a healthcare professional and/or to receive input from the healthcare professional could reasonably be alternatively or additionally interpreted as a field of use limitations. The claimed limitation of electronic medical records, is also interpreted as field of use limitation. Assuming the patient monitor is electronic, describing the monitor and the medical records as electronic, and describing the type of users of the interface, describe the environment in which the activities occur. As such, these limitations alone and in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. (MPEP 2106.05(h) Field of Use and Technological Environment).
Therefore, under Step 2A, Prong Two, the claims are directed to an abstract idea.
Step 2B: Identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)). (MPEP 2106.05)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a patient monitor, a user interface, a processor and a non-transitory computer-readable medium alone and in combination amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Similarly, the additional elements of patient monitor and user interface and electronic, are merely field of use limitations which neither alone nor in combination provide an inventive concept.
Therefore, claims 1-20 are not patent eligible.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over RAJASENAN, TERRY (US 8,515,777 Bl, hereinafter Rajasenan) in view of Austin et al. (US 2018/0122499 A1, hereafter Austin) in view of Sengupta (US 2011/0055620 A1, hereafter Sengupta)
As per claim 1, 6 and 7, Rajasenan discloses a method for monitoring, using a monitoring system, tasks performed in a medical system, comprising:
estimating an amount of demand/tasks to be performed during a first monitoring period, wherein the estimated amount of demand/tasks to be performed further comprises an estimated time of performance of the demand/tasks (Figure 3 healthcare demand model, see also [5:41-45] “Healthcare demand model 104 provides a prediction of the demand for healthcare services that needs to be satisfied” based on e.g., “documentation cues, etc.” [8:4-9] “healthcare provisioning engine” mines data “to see what was done based on available data, the time it was estimated to be done or exactly done” [24:49-51] and [3:60-65] wherein the first monitoring period could be “once a day, twice a day, weekly, or any other time frame.”, wherein supply and demand can be represented as a series of tasks);
determining an amount of supply/tasks performed during the first monitoring period, wherein determining further comprises determining a time of the tasks performed (Figure 4, healthcare supply model, see also [5:55-65] wherein the healthcare supply model uses “real-time healthcare clinical surveillance related to healthcare supply” e.g., “monitoring a healthcare provider's patient and task workload for all their patients … Other clinical data related to healthcare supply can be monitored and used to update the initial healthcare supply model.” [8:4-9] “healthcare provisioning engine” mines data “to see what was done based on available data, the time it was estimated to be done or exactly done” [24:49-51] wherein the first monitoring period could be once a day, twice a day, weekly, or any other time frame.”);
comparing the determined amount of tasks performed during the first monitoring period to the estimated amount of demand/tasks to be performed ([7:10-13] “… comparing supply and demand overload indicators”).
Rajasenan does not explicitly disclose that its demand/tasks or supply/tasks include information to be entered and entered into the EMR system; and wherein the healthcare professional is notified that information previously entered into or currently entered into the EMR system comprises a higher likelihood of error when the assigned reliability measure is below a predetermined reliability measure threshold.
However, Rajasenan discloses at least one EMR system with missing information (table in column [35] “Missing OrdSet”, table in column [52]: “Time Horizon View Discrepancies -- Clinical Mgmt Missing Charges”), and Austin teaches information to be entered into, entered into, and missing from an EMR system ([0004] “systems and techniques that flag possible errors and/or omissions of medical information, such as with respect to erroneous data entry in medical documentation or records”) as well as wherein a healthcare professional is notified that information previously entered into or currently entered into the EMR system comprises a higher likelihood of error when the assigned reliability measure is below a predetermined reliability measure threshold ([0090] “generate a patient list revealing lower risk scores of patients that may require internal audit to assess missing information. For instance, by flagging possible omissions of ICD codes for a patient, server 22 may alert system analyst end users of client computing device 12.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include information to be entered, entered and missing, in an EMR system, as taught by Austin, in the demand, supply and not-performed tasks respectively, disclosed by Rajasenan, in order to assist caretakers in a more targeted and granular manner, and since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Further, please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although optional recitations have been addressed with prior art, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that such recitations further limit the claimed method or structure.
However, Rajasenan and Austin may not explicitly disclose the following which is taught by Sengupta: determining a method of entering the data into the EMR system ([0013-0014] identification/determination of attributes/predictors of errors including identification of operator attributes including keystroke rate, Examiner interprets the keystroke rate to be the method of entering data, [0046] each data entry operator has a value of error, where the data entry operator is identified as the method of data entry, [0071] attributes which are identified to determine error include attributes of the data entry operator such as eye color or variability of keystroke rate, where the method of entering data is the entering by an identified operator);
estimating, based on the comparing and the determined method of entering the data into the EMR system, likelihood of error for the tasks performed during the first monitoring period ([0068] predicting the occurrence of errors based on the set of attributes identified including the method (operator attributes/keystroke rate) and the correlation between error/event and attribute, i.e. comparing, [0071-0072] predicting the occurrence of errors for the data entry task based on the identified attributes which correlate to errors in data entry, [0086] perform the quality management to predict errors real time, i.e. during data entry time); and
assigning, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from its EMR system ([0040] determine a measure of quality of the documents which have been by assigning weights to the occurrence of errors, i.e. likelihood of errors, and determine operational loss from the quality which indicates the loss due to errors in the fields of the document, therefore missing information from the EMR in the case of medical transcription as in [0037]); and
if the assigned reliability measure exceeds a threshold, automatically generating, by the monitoring system, an alert indicating the likelihood of error for the information entered into the EMR system ([0073] when the attribute, here the rate of data entry, is determined to have high variation, i.e. exceeds the threshold level which is how it is determined to be high, notifying the supervisor about the likelihood of an error occurring, [0037] where the data entry can be performed by medical transcription clerks recording medical record data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include estimating a likelihood of error based on user attributes correlated to predicting errors and assigning a quality measure for the tasks of entering information into documents of an EMR system, as taught by Sengupta, with the determination of quality process of healthcare tasks, disclosed by Rajasenan and Austin, in order to control the quality of healthcare tasks including data processing, where managing document quality is less time-consuming and errors are prevented (Sengupta [0008-0009]).
As per claims 2 and 8, Rajasenan, Austin, and Sengupta discloses the limitations of Claim 1. Rajasenan does not explicitly discloses labeling the information entered into the EMR system or the information missing from the EMR system based on the assigned reliability measure comprises metadata.
However, Austin teaches labeling the information entered into its EMR system or the information missing from its EMR system based on assigned reliability measure comprises metadata ([0069] “flag possible errors for missing ICD codes that are selected from a broader pool.”; and [0090] “administrators to fulfill data submission requirements as well as generate a patient list revealing lower risk scores of patients that may require internal audit to assess missing information. For instance, by flagging possible omissions of ICD codes for a patient, server 22 may alert system analyst end users of client computing device 12.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the teachings of Austin in the system of Rajasenan in order to prevent potential high risk mistakes, and since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Further, please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although optional recitations have been addressed with prior art, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that such recitations further limit the claimed method or structure.
As per claim 3, Rajasenan, Austin, and Sengupta discloses the limitations of Claim 1. Rajasenan further discloses wherein a higher likelihood of error is assigned when one or more of: information is entered into the EMR system after a lag period between obtaining the information and entering the information-;(ii) the tasks performed are about a patient with a high risk healthcare status ([20:34-47] “biometric sensors can be embedded in the healthcare providers clothing. The biometric sensors can make measurements of the healthcare provider's pulse rate, breathing rate, perspiration, etc. These measurements can be compared to previously stored measurements to obtain a real time estimate of the healthcare provider's stress level. This stress level, by itself, or in conjunction with complexity load analysis as described above can be used to determine whether the healthcare provider is nearing or has exceed a tipping point.”); (iii) the information is entered into the EMR system by an inexperienced healthcare professional; (iv) information is missing from the EMR system; (v) information is entered into the EMR system at a less reliable timepoint during a healthcare professional's shift; (vi) information is entered into the EMR system using a mechanism with a higher error rate. Please note that limitations not explicitly disclosed by Rajasenan have been addressed above in claim 1. Further, please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although optional recitations have been addressed with prior art, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that such recitations further limit the claimed method or structure.
As per claims 11 and 17, Rajasenan, Austin, and Sengupta discloses the limitations of Claims 10 and 16. Rajasenan further discloses wherein the estimated amount of demand/tasks is based on one or more of: (i) a number of patients being monitored during the first monitoring period; (ii) a healthcare status of one or more of the patients being monitored during the first monitoring period ([10:38-50] “predictive healthcare demand model is modified using real-time clinical surveillance data. For example, in an embodiment, such clinical surveillance related to healthcare demand includes monitoring a patient's condition”); (iii) a number of healthcare professionals participating in monitoring during the first monitoring period; or (iv) an experience level of one or more healthcare professionals participating in monitoring during the first monitoring period; (v) availability of one or more of the healthcare professionals participating in monitoring during the first monitoring period, (vi) a timepoint during a healthcare professional's shift; (vii) a location of the healthcare professional during a shift (viii) a mental or physical state of the healthcare professional; (ix) a monitoring situation of the patient; or (x) a guideline or protocol of a healthcare environment in which the patient is located; and wherein the estimated amount of information to be entered into the EMR system further comprises an estimated time of entry of the information ([8:4-9] “healthcare provisioning engine” mines data “to see what was done based on available data, the time it was estimated to be done or exactly done”). Please note that limitations not explicitly disclosed by Rajasenan have been addressed above in claim 1. Further, please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although optional recitations have been addressed with prior art, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that such recitations further limit the claimed method or structure.
As per claim 5, Rajasenan, Austin, and Sengupta discloses the limitations of Claim 1. Rajasenan further discloses further notifying a healthcare professional that information is missing from the EMR system (table in column [35] “Missing OrdSet”, table in column [52]: “Time Horizon View Discrepancies -- Clinical Mgmt Missing Charges”).
As per claim 9, Rajasenan, Austin, and Sengupta discloses the limitations of Claim 1. Rajasenan further discloses wherein the monitoring system comprises a patient monitor configured to provide information about one or more of: (i) a number of patients being monitored during the first monitoring period;(ii) a healthcare status of one or more of the patients being monitored during the first monitoring period; or (iii) an amount of information entered into the EMR system during the first monitoring period ([5:49-50] “using real-time clinical surveillance related to healthcare demand.” [7:4-5] “clinical surveillance data for current patient load being managed”). Further, please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although optional recitations have been addressed with prior art, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that such recitations further limit the claimed method or structure.
As per claims 12 and 18, Rajasenan, Austin, and Sengupta discloses the limitations of Claims 10 and 16. Rajasenan further discloses wherein determining an amount of tasks performed during the first monitoring period comprises determining a time of entry of the information into the EMR system ([8:4-9] “healthcare provisioning engine” mines data “to see what was done based on available data, the time it was estimated to be done or exactly done”). Please note that limitations not explicitly disclosed by Rajasenan have been addressed above in claim 1.
As per claims 14, 15 and 20, Rajasenan, Austin, and Sengupta discloses the limitations of Claims 10 and 16. Rajasenan further discloses wherein the processor is further configured to notify, via the user interface, a healthcare professional that information previously entered into or currently entered into the EMR system comprises a higher likelihood of error, or that information is missing from the EMR system (Table in column [35] “Missing OrdSet”, table in column [52]: “Time Horizon View Discrepancies -- Clinical Mgmt Missing Charges”), wherein the notification to the healthcare professional comprises a reason for the higher likelihood of error. Further, please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although optional recitations have been addressed with prior art, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that such recitations further limit the claimed method or structure.
As per claims 4, 10, 13, 16 and 19, these claims recite substantially similar limitation as claims 1, 3 and 11 and are rejected using the same art and rationale above.
Response to Applicant’s Arguments
Applicant’s arguments with respect to the 35 USC § 101 rejection have been considered but are not persuasive.
35 USC § 101
Regarding Step 2A, Prong One, Applicant argues on page 11:
The generation of such alert clearly does not constitute a mental process or certain methods of organizing human activities.
In response and under the broadest reasonable interpretation, the examiner respectfully disagrees. The generation of an alert for the condition of a reliability measure exceeding a threshold
It is respectfully submitted that "organizing human activities" was applied to the limitation “generate an alert indicating the likelihood of error for the information entered into the EMR system”. There is nothing in the claim language that precludes the generating step to be performed by interaction between humans; e.g., a person generates an alert when the reliability measure exceeds a threshold by notifying another party of the error condition.
Please note that MPEP 2106.04(a) recites “It should be noted that these groupings are not mutually exclusive, i.e., some claims recite limitations that fall within more than one grouping or sub-grouping.” Further, MPEP 2106.04(a)(II)(C) provides an example relevant to the limitation above; i.e., “Another example of a claim reciting social activities is Interval Licensing LLC, v. AOL, Inc., 896 F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue was the social activity of "’providing information to a person without interfering with the person’s primary activity.’"”
Regarding Step 2A, Prong Two, Applicant argues on page 11:
MPEP §2106.04(d)(l) specifies that one way to demonstrate such integration into a
practical application is when the claimed invention improves a technical field. MPEP
§2106.04(d)(l) further states that "the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity."
In response, the examiner agrees with the above statement, and further submits that the improvement refers to claimed elements beyond the abstract idea, not to the abstract idea itself. Please see MPEP 2106.04(d)(II) titled HOW TO EVALUATE WHETHER THE ADDITIONAL ELEMENTS INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION recites in part (emphasis added):
Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).
Applicant further argues on page 12:
Indeed, the claimed invention improves the technical field of medical record systems. In
particular, the claimed invention addresses the issue of problematic data (incorrect or missing) by automatically generating, by a monitoring system, an alert indicating the likelihood of error for the information entered into the EMR system based on the monitoring system comparing estimated and determined amounts of data into the EMR and the method of entry of the data to assign a reliability measure.
In response, per MPEP 2106.04(d)(II) cited above, the analysis of whether there is an improvement in technology or technical field, pertains to limitations beyond the abstract idea.
It is respectfully submitted that applicant appears to argue that limitations which were identified as part of the abstract idea provide a technological improvement. Specifically, the generation of an alert when the reliability measure exceeds a threshold is part of the abstract idea falling into the grouping of certain methods of organizing human activity. However, the additional limitations beyond the abstract idea were addressed in the Rejection above and concluded that they do not, alone or in combination, improve technology or technical field.
Regarding Example 42, Applicant argues on page 13:
… the Office examined these additional elements to see if the combination of these additional elements recite a specific improvement over the prior art. The Office determines that the combination of the additional elements indeed recite the specific improvement of "allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user." Similarly, the combination of the additional element of claim 1 of the present application should be analyzed to determine if they recite a specific improvement.
In response, the examiner agrees and submits that such analysis was performed in determining eligibility. Please see USC 101 rejection above. Specifically, Applicant argues that automatically alerting the user to the likelihood of an error for the information entered into an EMR system provides a specific improvement over the prior art. Examiner respectfully disagrees and notes that generating an alert when the reliability measure exceeds a threshold is part of the abstract idea itself and therefore not an additional element considered in Step 2A, prong two.
Regarding step 2B, Applicant argues on page 13:
The additional limitations of claim 1 indeed contributes an inventive concept that
improves the field of medical record system. In particular, the claimed invention addresses automatically alerting a user to problematic data (incorrect or missing) entered into electronic medical records by comparing the amount of information to entered into the EMR system to the estimated amount during a monitoring period to estimate a likelihood of error and assign a reliability measure to the information entered into the EMR system.
In response, it is respectfully submitted that applicant appears to argue that limitations which were identified as part of the abstract idea (generating an alert) contribute an inventive concept. However, the additional limitations beyond the abstract idea were addressed in the Rejection above and concluded that they do not, alone or in combination, provide an inventive concept.
35 USC § 103
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that Rajasenan and Austin do not teach determining a method of entering data into the EMR system; estimating, based on the comparing and the determined method of entering the data into the EMR system, a likelihood of error for the information entered the EMR system during the first monitoring period, as well as assigning a reliability measure. Examiner notes that these limitations are rejected in view of Sengupta, which is necessitated in response to the amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682