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 .
Response to Amendment
The terminal disclaimer received on 04/13/2026 has been approved and accepted. The previous double patenting rejections have been removed.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 04/13/2026, the following has occurred: claims 1-2, 4, 6-9, 11, 13-16, and 19-20 have been amended; claims 3, 5, 10, 12, and 17-18 remain unchanged; and claim 21 has been added.
Claims 1-21 are pending.
Effective Filing Date: 08/24/2017
Response to Arguments
Double Patenting:
Examiner withdraws these previous claim rejections in view of the terminal disclaimer received on 04/13/2026.
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant argues that the claims of not recite an abstract idea categorized under certain methods of organizing human activity. Applicant further states that human cannot access and process large-scale EMR data stores. These arguments are not supported by the claims language. Additionally, Applicant states that the sampling of data and generation of risk score cannot be performed by a human as claimed. Examiner however respectfully disagrees as the present claims do indeed recite an abstract concept with additional elements. A human can access data and generate a score. The quantity of data being a large quantity is not reflected in the claims. Furthermore, the timeliness aspect of the invention is unclear based on the lack of details as to what types of events are being referred to/what are the metes and bounds of these events (Examiner elaborated upon this in the response to the 103 arguments section below).
Applicant further states that the claims do not include a mathematical concept and cites Thales. Examiner however respectfully disagree as the claims do include logistical regression analysis.
Step 2A, Prong Two:
Applicant states that the claims integrate the abstract idea into a practical application and cites to Ex Parte Desjardins. The Examiner respectfully submits that there is no improvement to the claim machine learning as there is in Desjardins. As found by the Panel, the claimed “training strategy allows the model to preserve performance on earlier tasks even as it learns new ones, directly addressing the technical problem of 'catastrophic forgetting' in continual learning systems" represents “technical improvements over conventional systems by addressing challenges in continual learning and model efficiency by reducing storage requirements and preserving task performance across sequential training.” This analysis represents implementation of the practical application-“improvement” analysis of MPEP 2106.04(d)(I) to the facts before the Panel.
Applicant’s claims do not provide such an improvement. Initially, there is no training within the claims so this argument falls on its face from the outset. Even assuming there was, there is no indication in the cited portion of the Specification that the claimed invention provides an improvement.
Step 2B:
Lastly, Applicant states that the claims recite significantly more than the abstract idea. Examiner however respectfully disagree. The claims recite an abstract idea with additional elements which either apply the abstract idea using generic computing components or add well-understood, routine, and conventional activity to the claims.
35 U.S.C. 103 Rejections:
Applicant argues that the present claims overcome the claims do not teach the amended claim set. Examiner however respectfully disagrees. Applicant points towards the 1) “based on the information received by the electronic medical record store”, 2) “during the first medical event”, and 3) “initiating database operations” limitations.
The previous references do indeed teach 1) “based on the information received by the electronic medical record store” and this can be seen below in the updated 103 rejection section.
Examiner however would like to respectfully point out that there is broadness to the current claim limitation of 2) “during the first medical event”. There is a determination of the first medical event and then operations occurring during the first medical event. How can operations occur during a medical event if the event has not first been detected? Furthermore, how can an operation be both in response to determining an event and during an event? There is broadness to what the start point and end point of the medical event is. One more thing to note, the metes and bounds of “currently experiencing” is broad depending on the event itself. A heart attack can be an event which is currently experienced as the heart rate is elevated. A period of time where someone experiences a range of normal heart rate to an arrhythmia can be considered as another event, and though they might be at a normal heart rate they could still be considered as “currently experiencing” an event until there is a resolution to the arrhythmia.
Additionally, the 3) “initiating database operations” limitation is also taught using the previous references and this can be seen below in the updated 103 rejection section.
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 1-21 are rejected under 35 U.S.C. 101 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. Claims 1-7 are drawn to a media, claims 8-14 are drawn to a method, and claims 15-20 are drawn to a system, each of which is within the four statutory categories. Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites one or more non-transitory computer-readable media comprising instructions which, when executed by a) one or more hardware processors, cause performance of operations comprising:
1) receiving, by b) an electronic medical record store, from a medical device, information for an individual;
2) based on the information received by the electronic medical record store, determining that the individual is currently experiencing a first medical event, wherein the first medical event is a medical emergency and wherein the information is collected from the individual by the medical device while the medical device is connected to the individual; and
3) in response to determining the first medical event for the individual and during the occurrence of the first medical event:
3a) initiating database operations for determining a probability of a second medical event, the database operations including:
3a1) sampling, from a plurality of medical data elements in the electronic medical record store that are associated with the individual, a pre-selected set of medical data elements for predicting a probability of occurrence of a second medical event based on the first medical event; and
3a2) generating an event risk score for the individual by performing a logistical regression analysis of the pre-selected set of medical data elements sampled from the electronic medical record store, wherein the event risk score indicates the probability of the second medical event for the individual;
4) wherein generation of the event risk score triggers at least one of:
(a) generation of one or more recommendations for medical interventions to reduce the probability for the individual of the second medical event;
(b) creation of a customized medical management plan to reduce the probability for the individual of the second medical event; and
(c) modification of c) an electronic medical record (EMR) of the individual to indicate the event risk score for the second medical event.
Claim 1 recites, in part, performing the steps of 2) based on the information received by the medical record store (when a paper or mental storage), determining that the individual is currently experiencing a first medical event, wherein the first medical event is a medical emergency and wherein the information is collected from the individual by the medical device while the medical device is connected to the individual and 3) in response to determining the first medical event for the individual and during the occurrence of the first medical event: 3a1) sampling, from a plurality of medical data elements in the medical record store that are associated with the individual, a pre-selected set of medical data elements for predicting a probability of occurrence of a second medical event based on the first medical event, and 3a2) generating an event risk score for the individual by performing a logistical regression analysis of the pre-selected set of medical data elements sampled from the medical record store, wherein the event risk score indicates the probability of the second medical event for the individual, and 4) wherein generation of the event risk score triggers at least one of: (a) generation of one or more recommendations for medical interventions to reduce the probability for the individual of the second medical event, (b) creation of a customized medical management plan to reduce the probability for the individual of the second medical event, and (c) modification of a medical record (MR) of the individual to indicate the event risk score for the second medical event. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes how an individual could use a patient’s data in order to treat an individual generically (see: MPEP 2106.04(d)(2) for why the treatment of the present claims is not particular).
Claim 1 also recites, in part, performing the step of 3a2) generating an event risk score for the individual by performing a logistical regression analysis of the pre-selected set of medical data elements sampled from the medical record store, wherein the event risk score indicates the probability of the second medical event for the individual. This step corresponds to Mathematical Concepts.
Going forward, the above abstract concepts will be considered as a singular abstract idea. Independent claims 8 and 15 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-7, 9-14, and 16-21 include all of the limitations of claims 1, 8, and 15, and therefore likewise incorporate the above described abstract idea. Depending claims 4 and 11 add the additional step of “automatically communicated to the patient”; claims 7, 14, and 20 add the additional step of “accessing the event risk score in the EMR”; claim 16 adds the additional step of “wherein the individual is treated in accordance with the one or more recommendations for medical interventions to reduce the probability for the patient of the occurrence of the second medical event”; and claim 21 adds the additional step of “wherein generation of the event risk score triggers modification of the EMR of the individual to indicate the event risk score for the second medical event”. Additionally, the limitations of depending claims 2-3, 5-6, 9-10, 12-13, and 17-19 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-7, 9-14, and 16-21 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 8, and 15 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) one or more hardware processors/at least one device including a processor (from claim 15), b) an electronic medical record store, and c) an electronic medical record (EMR) to perform the claimed steps.
The claims also include the additional element step of 1) “receiving, by an electronic medical record store, from a medical device, information for an individual”.
The a) one or more hardware processors/at least one device including a processor, b) an electronic medical record store, and c) an electronic medical record (EMR) in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraph [0019] where the processor can be a generic component, see MPEP 2106.05(f)).
Also, the additional element step of 1) “receiving, by an electronic medical record store, from a medical device, information for an individual” in these steps adds insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, see MPEP 2106.05(g).
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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
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. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
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 using a) one or more hardware processors/at least one device including a processor, b) an electronic medical record store, and c) an electronic medical record (EMR) to perform the claimed steps and the additional element step of 1) “receiving, by an electronic medical record store, from a medical device, information for an individual” amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity) and mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity and certain mathematical concepts. Specifically, MPEP 2106.05(d) and MPEP 2106.05(f) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention generates a risk score utilizing a) one or more hardware processors/at least one device including a processor, b) an electronic medical record store, and c) an electronic medical record (EMR), thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Additionally, the additional element step of 1) “receiving, by an electronic medical record store, from a medical device, information for an individual” adds insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives medical device data, and transmits the data to system over a network, for example the Internet.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-21 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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.
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.
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.
Claims 1-4, 8-11, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0305675 to Miller et al. in view of U.S. 2017/0337345 to Pauws et al.
As per claim 1, Miller et al. teaches one or more non-transitory computer-readable media comprising instructions which, when executed by one or more hardware processors (see: paragraph [0033] where there is a processor), cause performance of operations comprising:
--receiving, by an electronic medical record store, from a medical device, information for an individual; (see: paragraphs [0042] and [0072] where there is reception of data from a device (sensor measurements) by the store (server))
--based on the information received by the electronic medical record store, determining that the individual is currently experiencing a first medical event, (see: 1610 and 1620 of FIG. 16 where there is a determination that a person is experiencing an event based on information provided by a wearable using an input device (which has access to a medical record store of information from the wearable)) wherein the first medical event is a medical emergency and wherein the information is collected from the individual by the medical device while the medical device is connected to the individual; (see: paragraph [0103] where the event is an emergency and the information being collected is being collected as the person is wearing the device) and
--in response to determining the first medical event for the individual and during the first medical event:
--initiating database operations for determining a probability of a second medical event, (see: paragraph [0143] where there is initiation of operations using a server for the invention which includes a probability determination) the database operations including:
--predict a second event (see: paragraph [0052] where there is prediction of a second event based on the first. In other words, there is a prediction of a second event in response to determining the occurrence of the first medical event and it can be during the first occurrence of the event).
Miller et al. may not further, specifically teach predict a second event as:
1) --operations including:
1a) --sampling, from a plurality of medical data elements in the electronic medical record store that are associated with the individual, a pre-selected set of medical data elements for predicting a probability of a second medical event based on the first medical event; and
1b) --generating an event risk score for the individual by performing a logistical regression analysis of the pre-selected set of medical data elements sampled from the electronic medical record store, wherein the event risk score indicates the probability of the second medical event for the individual;
2) --wherein generation of the event risk score triggers at least one of:
2a) --(a) generation of one or more recommendations for medical interventions to reduce the probability for the individual of the occurrence of the second medical event;
2b) --(b) creation of a customized medical management plan to reduce the probability for the patient of the occurrence of the second medical event; and
2c) --(c) modification of an electronic medical record (EMR) of the patient to indicate the event risk score for the occurrence of the second medical event.
Pauws et al. teaches:
--predict a second event as:
1) --operations including:
1a) --sampling, from a plurality of medical data elements in the electronic medical record store that are associated with the individual, a pre-selected set of medical data elements for predicting a probability of a second medical event based on the first medical event; (see: paragraphs [0010] and [0072] where other subject risk profiles are being gathered for comparison with the subject’s risk profile to determine matches. The pre-selected set of medical data elements here is the time series of risk scores) and
1b) --generating an event risk score for the individual by performing a logistical regression analysis of the pre-selected set of medical data elements sampled from the electronic medical record store, (see: paragraph [0099] where a logistic regression model may be used that scores the likelihood of hospitalization where the likelihood is the second risk event score for the subject. This is done based on an analysis of the time series of risk scores (sampled medical elements)) wherein the event risk score indicates the probability of the second medical event for the individual; (see: paragraph [0010] where the event risk score here is a likelihood of occurrence of a medical event (second event) for a subject).
2) --wherein generation of the event risk score triggers at least one of:
2a) --(a) generation of one or more recommendations for medical interventions to reduce the probability for the individual of the second medical event; (see: paragraph [0103] where there is generation of a recommendation when the likelihood of a medical event occurring is above 35% with the goal of reducing the likelihood of the occurrence)
2b) --(b) creation of a customized medical management plan to reduce the probability for the individual of the second medical event; (see: paragraph [0103] where there is generation of a recommendation when the likelihood of a medical event occurring is above 35%. This can also be viewed as creation of a management plan with the goal of reducing the likelihood of the occurrence) and
2c) --(c) modification of an electronic medical record (EMR) of the individual to indicate the event risk score for the second medical event (does not need to be met in a method claim as at least one of the above is present).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 1) operations including: 1a) sampling, from a plurality of medical data elements in the electronic medical record store that are associated with the individual, a pre-selected set of medical data elements for predicting a probability of occurrence of a second medical event based on the first medical event and 1b) generating an event risk score for the individual by performing a logistical regression analysis of the pre-selected set of medical data elements sampled from the electronic medical record store, wherein the event risk score indicates the probability of the second medical event for the individual as taught by Pauws et al. for the step of predicting a second event as disclosed by Miller et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Miller et al. already teaches of prediction of a second event using a first event thus one could substitute how that second event is found and obtain predictable results of predicting a second event. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Additionally, one of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 2) wherein generation of the event risk score triggers at least one of: 2a) (a) generation of one or more recommendations for medical interventions to reduce the probability for the individual of the second medical event, 2b) (b) creation of a customized medical management plan to reduce the probability for the individual of the second medical event, and 2c) (c) modification of an electronic medical record (EMR) of the individual to indicate the event risk score for the second medical event as taught by Pauws et al. in the media as taught by Miller et al. with the motivation(s) of improving the condition of the subject (see: paragraph [0004] of Pauws et al.).
As per claim 2, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. Pauws et al. further teaches wherein the individual is treated in accordance with the one or more recommendations for medical interventions to reduce the probability for the individual of the second medical event (see: paragraphs [0012] and [0087] where the risk score can be factored in to help provide a treatment to a patient).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 3, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. Miller et al. further teaches wherein the creation of the customized medical management plan comprises providing to the individual one or more of:
i. a recommendation for cessation of one or more risk increasing activities; (see: paragraph [0067] where there is a recommendation of ceasing the current activity)
ii. an appointment for follow-up with a medical professional; and
iii. education regarding one or more of the first medical event and the second medical event.
As per claim 4, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. Pauws et al. teaches wherein the customized medical management plan is automatically communicated to the individual (see: paragraphs [0011] and [0097] where an action may be taken to prevent the occurrence of the medical event when the likelihood of the medical event (the event risk score) exceeds a threshold. Also a user is provided with a notification or information on any possible medical event such that an appropriate action can be taken. The action here would be the management plan and there is an option to communicate a message to the individual).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 8, claim 8 is similar to claim 1 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination.
As per claim 9, claim 9 is similar to claim 2 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination.
As per claim 10, claim 10 is similar to claim 3 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination.
As per claim 11, claim 11 is similar to claim 4 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination.
As per claim 15, claim 15 is similar to claim 1 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination. Miller et al. further teaches a system comprising:
--at least one device including a hardware processor (see: paragraph [0033] where there is a processor).
As per claim 16, claim 16 is similar to claim 2 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination.
As per claim 17, claim 17 is similar to claim 3 and is rejected in a similar manner to Miller et al. and Pauws et al. in combination.
Claims 5-6 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0305675 to Miller et al. in view of U.S. 2017/0337345 to Pauws et al. as applied to claims 1 and 8, and further in view of U.S. 2015/0095046 to Pironti et al.
As per claim 5, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein modifying the EMR comprises one or more of:
--i. modifying an existing data element within the EMR;
--ii. adding a new data element to the EMR; or
--iii. overwriting an existing data element with a new data element.
Pironti et al. teaches:
--wherein modifying the EMR comprises one or more of:
--i. modifying an existing data element within the EMR;
--ii. adding a new data element to the EMR; or
--iii. overwriting an existing data element with a new data element (see: FIG. 7 and paragraph [0033] where a health plan member is assigned to a risk tier based on their scores).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein modifying the EMR comprises one or more of: i. modifying an existing data element within the EMR, ii. adding a new data element to the EMR, or iii. overwriting an existing data element with a new data element as taught by Pironti et al. in the media as taught by Miller et al. and Pauws et al. in combination with the motivation(s) of detecting conditions to mitigate risk of health plan members (see: paragraphs [0004] – [0005] of Pironti et al.).
As per claim 6, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein modifying the EMR of the individual includes identifying an event risk score category, wherein identifying the event risk score comprises:
--assigning the event risk score to one of a low probability risk category, a moderate probability risk category, or a high probability risk category, wherein the low probability risk category corresponds to the event risk score in a first range, the moderate probability risk category corresponds to the event risk score in a second range, and the high probability risk category corresponds to the event risk score in a third range.
Pironti et al. teaches:
--wherein modifying the EMR of the individual includes identifying an event risk score category, wherein identifying the event risk score comprises:
--assigning the event risk score to one of a low probability risk category, a moderate probability risk category, or a high probability risk category, (see: FIG. 3 and paragraph [0031] where the scores are used to categorize a person into 1 to 3 categories including a low, moderate, or high category tier assignment is indicative of new data whether it be in place of old data or not) wherein the low probability risk category corresponds to the event risk score in a first range, the moderate probability risk category corresponds to the event risk score in a second range, and the high probability risk category corresponds to the event risk score in a third range (see: FIG. 3 and paragraph [0031] where the scores fall into categories. Also see: FIG. 6 where scores are being assessed to determine if they fall outside of threshold amounts (ranges)).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein modifying the EMR of the individual includes identifying an event risk score category, wherein identifying the event risk score comprises: assigning the event risk score to one of a low probability risk category, a moderate probability risk category, or a high probability risk category, wherein the low probability risk category corresponds to the event risk score in a first range, the moderate probability risk category corresponds to the event risk score in a second range, and the high probability risk category corresponds to the event risk score in a third range as taught by Pironti et al. in the media as taught by Miller et al. and Pauws et al. in combination with the motivation(s) of detecting conditions to mitigate risk of health plan members (see: paragraphs [0004] – [0005] of Pironti et al.).
As per claim 12, claim 12 is similar to claim 5 and is therefore rejected in a similar manner as claim 5 using the Miller et al., Pauws et al., and Pironti et al. references in combination.
As per claim 13, claim 13 is similar to claim 6 and is therefore rejected in a similar manner as claim 6 using the Miller et al., Pauws et al., and Pironti et al. references in combination.
Claims 7, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0305675 to Miller et al. in view of U.S. 2017/0337345 to Pauws et al. further in view of U.S. 2020/0058408 to Jain et al.
As per claim 7, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. Pauws et al. teaches wherein the operations further comprise
--treating the individual based on the event risk score (see: paragraphs [0012] and [0087] where the risk score can be factored in to help provide a treatment to a patient).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
Miller et al. and Pauws et al. in combination may not further, specifically teach:
--accessing the event risk score in the EMR; and
--the event risk score accessed in the EMR.
Jain et al. teaches:
--accessing the event risk score in the EMR; (see: paragraph [0004] where there is accessing of a score in an EMR) and
--the event risk score accessed in the EMR (see: paragraph [0004] where there is accessing of a score in an EMR).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to access the event risk score in the EMR and the event risk score accessed in the EMR as taught by Jain et al. in the system as taught by Miller et al. and Pauws et al. in combination with the motivation(s) of improving clinical pathways for disease treatment (see: paragraph [0001] of Jain et al.).
As per claim 14, claim 14 is similar to claim 7 and is rejected in a similar manner to Miller et al., Pauws et al., and Jain et al. in combination.
As per claim 20, claim 20 is similar to claim 7 and is rejected in a similar manner to Miller et al., Pauws et al., and Jain et al. in combination.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0305675 to Miller et al. in view of U.S. 2017/0337345 to Pauws et al. as applied to claim 15, and further in view of U.S. 2015/0095046 to Pironti et al.
As per claim 18, Miller et al. and Pauws et al. in combination teaches the system of claim 15, see discussion of claim 15. The combination may not further, specifically teach wherein modifying the EMR comprises one or more of:
--i. modifying an existing data element within the EMR;
--ii. adding a new data element to the EMR; or
--iii. overwriting an existing data element with a new data element.
Pironti et al. teaches:
--wherein modifying the EMR comprises one or more of:
--i. modifying an existing data element within the EMR;
--ii. adding a new data element to the EMR; or
--iii. overwriting an existing data element with a new data element (see: FIG. 7 and paragraph [0033] where a health plan member is assigned to a risk tier based on their scores).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein modifying the EMR comprises one or more of: i. modifying an existing data element within the EMR, ii. adding a new data element to the EMR, or iii. overwriting an existing data element with a new data element as taught by Pironti et al. in the system as taught by Miller et al., Pauws et al., and Jain et al. in combination with the motivation(s) of detecting conditions to mitigate risk of health plan members (see: paragraphs [0004] – [0005] of Pironti et al.).
As per claim 19, Miller et al., Pauws et al., and Jain et al. in combination teaches the media of claim 15, see discussion of claim 15. The combination may not further, specifically teach wherein the operations further comprise:
--assigning the event risk score to one of a low probability risk category, a moderate probability risk category, or a high probability risk category, wherein the low probability risk category corresponds to the event risk score in a first range, the moderate probability risk category corresponds to the event risk score in a second range, and the high probability risk category corresponds to the event risk score in a third range, wherein a value of the event risk score in the third range is greater than a value of the event risk score in the second range, and a value of the event risk score in the second range is greater than a value of the event risk score in the first range.
Pironti et al. teaches:
--wherein the operations further comprise:
--assigning the event risk score to one of a low probability risk category, a moderate probability risk category, or a high probability risk category, (see: FIG. 3 and paragraph [0031] where the scores are used to categorize a person into 1 to 3 categories including a low, moderate, or high category tier assignment is indicative of new data whether it be in place of old data or not) wherein the low probability risk category corresponds to the event risk score in a first range, the moderate probability risk category corresponds to the event risk score in a second range, and the high probability risk category corresponds to the event risk score in a third range, (see: FIG. 3 and paragraph [0031] where the scores fall into categories. Also see: FIG. 6 where scores are being assessed to determine if they fall outside of threshold amounts (ranges)) wherein a value of the event risk score in the third range is greater than a value of the event risk score in the second range, and a value of the event risk score in the second range is greater than a value of the event risk score in the first range (see: FIG. 7 and paragraph [0033] where a health plan member is assigned to a risk tier based on their scores).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the operations further comprise: assigning the event risk score to one of a low probability risk category, a moderate probability risk category, or a high probability risk category, wherein the low probability risk category corresponds to the event risk score in a first range, the moderate probability risk category corresponds to the event risk score in a second range, and the high probability risk category corresponds to the event risk score in a third range, wherein a value of the event risk score in the third range is greater than a value of the event risk score in the second range, and a value of the event risk score in the second range is greater than a value of the event risk score in the first range as taught by Pironti et al. in the system as taught by Miller et al., Pauws et al., and Jain et al. in combination with the motivation(s) of detecting conditions to mitigate risk of health plan members (see: paragraphs [0004] – [0005] of Pironti et al.).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2015/0305675 to Miller et al. in view of U.S. 2017/0337345 to Pauws et al. as applied to claim 1, and further in view of U.S. 2010/0114602 to Joao et al.
As per claim 21, Miller et al. and Pauws et al. in combination teaches the media of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein generation of the event risk score triggers modification of the EMR of the individual to indicate the event risk score for the second medical event.
Joao et al. teaches:
--wherein generation of the event risk score triggers modification of the EMR of the individual to indicate the event risk score for the second medical event (see: Abstract where there is a modification of the EMR upon determining an updated risk score).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein generation of the event risk score triggers modification of the EMR of the individual to indicate the event risk score for the second medical event as taught by Joao et al. in the media as taught by Miller et al. and Pauws et al. in combination with the motivation(s) of promoting efficient information collection (see: paragraph [0129] of Joao et al.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
Prosecution Insights