DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/07/2026 has been entered.
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
In light of the amendments, the claims are rejected under 35 U.S.C. 112(a).
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the previous 35 U.S.C. 103 rejections are withdrawn.
Notice to Applicant
In the amendment dated 07/07/2026, the following has occurred: claims 1, 7-8 10-11, 17-18, and 20-21 have been amended; claims 2-6, 9, 12-16, and 19 remain unchanged; and claims 22-24 have been added.
Claims 1-24 are pending.
Effective Filing Date: 08/24/2017
Response to Arguments
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant argues that the claims are not directed towards certain methods of organizing human activity. Applicant points to the following limitations as being limitations which are specific automated computer operation on a structured database system: (a) determines a first medical event of a specific type is currently occurring, (b) accesses a listing of medical data elements that was established before the event occurred, (c) samples from the EMR store only those data elements that correspond to the listing, and (d) performs logistic regression on the resulting constrained set to generate a risk score. These limitations however are not database specific, as they recite operations that people could do. The only difference is the recitation of these operations being database operations. The initiation of database operations is an additional element however, whereas the operations are included as part of the abstract idea. Furthermore, these database operations are not described in the specification (“database” is not even mentioned) so how are these operations more than just applying the abstract idea or general linking the abstract idea?
Applicant also argues that the claims should not be oversimplified in view of Desjardins. Applicant states that using a patient’s data to treat a patient is an oversimplification and reduced the claim’s specific database architecture. Examiner however respectfully disagrees as the phrase “specific architecture” is indicative of specific technical infrastructure, not a recitation of using computing components and initiating database operations. Reciting operations being database operations when these operations could be operations performed by a person makes the recitation of the database operations within the claims an additional element in the form of apply it. What is the specific architecture referring to? The functions performed by the computing components in addition to the computing components?
Additionally, the limitation involving treating the patient was deemed an additional element and was further analyzed in Step 2A, Prong Two.
Applicant also argues that the logistic regression in the claims is not directed towards a mathematical concept as the recitation within the claims is tightly bounded to database-architectural limitations. Applicant points to McRO when arguing this. Examiner however respectfully disagrees as the claims do indeed recite a mathematical concept when generating a score. Even though there is recitation of computing components, the generation of the risk score here is not tightly bounded to database-architectural limitations. This calculation is performed by a database, where the database is applied to the abstract idea involving the mathematical calculation.
Step 2A, Prong Two:
Applicant argues there is a specific improvement to computer and database technology. Applicant points to the claimed invention and states that there is reduction in response speed and wasted computational resources. The claimed invention is supposed to reduce the number of database reads, the volume of data retrieved, and the computational complexity of the regression operation. The specification however does not elude to this. The specification does discuss reduction in navigational burden via having updated data in paragraph [0053]. Furthermore, using processing a specific set of data as opposed to processing an entire set of data would lead to less utilization of computational resources as it is a byproduct of using less data. Applicant points to statistically significant data as being important data. Performing operations on important data as opposed to performing operations on all data leading to less usage of computational resources is a byproduct of using less data. Using better data is an improvement to the data itself.
Applicant also points to Desjardins and states that the improvements to how a technical system operates, including how it accesses and process information, satisfy the practical application inquiry. Applicant further points to certain additional elements and states that the Office dismisses these elements as being generic. Examiner however respectfully disagrees. These additional elements are generic as they are listed in a manner where it is applying the abstract idea using technology. These components being generic are further supported by the specification lacking a description of being anything but generic components. Applicant eludes to improving how and when database operation occur in a resource-constrained environment. Examiner respectfully disagrees with Applicant’s parallels with Ex Parte Desjardins as Desjardins is specifically directed to a specific, technical improvement of the functioning of an artificial intelligence model itself with explicit support in the specification. In the instant application, the assertion that the method of the instant application reduces consumption of computer resources compared to other systems that do not perform the method is simply an intended result that may or may not occur. MPEP 2106.05(f) recites: “a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception. See Internet Patents Corporation v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015) (The recitation of maintaining the state of data in an online form without restriction on how the state is maintained and with no description of the mechanism for maintaining the state describes "the effect or result dissociated from any method by which maintaining the state is accomplished" and does not provide a meaningful limitation because it merely states that the abstract idea should be applied to achieve a desired result).”
Applicant further states that the claims recite a particular solution, not a general outcome and that the claims must be evaluated as a whole. The claims are being evaluated as a whole and they do not integrate the abstract into a practical application.
Step 2B:
Applicant states that the claims recite significantly more and also recites BASCOM. The claims of BASCOM recite user-specific web filters that are non-conventionally and non-routinely located at the ISP server rather than a user’s device. The present claims do not recite a non-conventional and non-routine arrangement of elements. Applicant points to the regression and states that this is not a conventional implementation. The regression is considered as part of the abstract idea however, so it not a question of whether it is deemed routine or not.
35 U.S.C. 103 Rejections:
Examiner withdraws the previous claim rejections in view of the amendments to the claims.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 11, and 20 each recite initiation of database operations involving accessing a listing of pre-selected medical data elements. The initiation is not described in the specification, nor is the accessing of this specified listing leading Examiner to question whether Applicant had possession over the claimed invention at the time of filing.
Claims 2-10, 12-19, and 21-24 are rejected based on their dependency on claims 1 and 11.
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 1-24 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 1-10 and 21-24 are drawn to a media, claims 11-19 are drawn to a method, and claim 20 is drawn to a system, each of which is within the four statutory categories. Claims 1-24 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 c) a medical device, information for an individual;
2) based on the information received by the electronic medical record store from the medical device, determining that the individual is currently experiencing an occurrence of a first medical event of a type, wherein the first medical event is a medical emergency and c) 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 occurrence of the first medical event for the individual and during the occurrence of the first medical event:
d) initiating database operations for 3a) determining a probability of a second medical event occurring for the individual (a) based on the occurrence of the first medical event and (b) within a predetermined timeframe of the occurrence of the first medical event, the database operations including:
3a1) accessing a listing of pre-selected medical data elements for predicting the probability of the second medical event occurring for the individual, wherein the listing of pre-selected medical data elements is (a) established prior to determining the occurrence of the first medical event and (b) corresponds to the type of the first medical event;
3a2) sampling, from a plurality of medical data elements in the electronic medical record store that are associated with the individual, a set of medical data elements of the individual corresponding to the listing of pre-selected medical data elements; and
3a3) generating an event risk score for the individual by performing a logistical regression analysis of the set of medical data elements of the individual corresponding to the listing of pre-selected medical data elements wherein the event risk score indicates the probability of the second medical event occurring for the individual within the predetermined timeframe of the occurrence of the first medical event;
4) wherein the individual is treated based at least in part on the event risk score.
Claim 1 recites, in part, performing the steps of 2) based on the information received by the medical record store (when mental memory or a pen and paper), determining that the individual is currently experiencing an occurrence of a first medical event of a type, wherein the first medical event is a medical emergency and 3) in response to determining the occurrence of the first medical event for the individual and during the occurrence of the first medical event: 3a) determining a probability of a second medical event occurring for the individual (a) based on the occurrence of the first medical event and (b) within a predetermined timeframe of the occurrence of the first medical event, the database operations including: 3a1) accessing a listing of pre-selected medical data elements for predicting the probability of the second medical event occurring for the individual, wherein the listing of pre-selected medical data elements is (a) established prior to determining the occurrence of the first medical event and (b) corresponds to the type of the first medical event, 3a2) sampling, from a plurality of medical data elements in the electronic medical record store that are associated with the individual, a set of medical data elements of the individual corresponding to the listing of pre-selected medical data elements, and 3a3) generating an event risk score for the individual by performing a logistical regression analysis of the set of medical data elements of the individual corresponding to the listing of pre-selected medical data elements wherein the event risk score indicates the probability of the second medical event occurring for the individual within the predetermined timeframe of the occurrence of the first 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 steps of 3a3) generating an event risk score for the individual by performing a logistical regression analysis of the set of medical data elements of the individual corresponding to the listing of pre-selected medical data elements wherein the event risk score indicates the probability of the second medical event occurring for the individual within the predetermined timeframe of the occurrence of the first medical event. This step corresponds to Mathematical Concepts.
Going forward, the above abstract concepts will be considered as a singular abstract idea. Independent claims 11 and 20 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-10, 12-19, and 21-24 include all of the limitations of claims 1 and 11, and therefore likewise incorporate the above described abstract idea. Depending claims 3-6, 8, 10, 13-16, 18, and 21 add additional, functional steps to the claims. Claim 24 elaborates upon the mathematical concept of the abstract idea. Claims 22-23 elaborate upon the database operations but add functional limitations which amount to an elaboration upon the abstract idea. Claim 22 does however add the additional element of f) a scheduling component which is further addressed in Prong Two. Additionally, the limitations of depending claims 2, 7, 9, 12, 17, and 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 2-10, 12-19, and 21-24 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 11 (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, b) an electronic medical record store, c) a medical device, wherein the information is collected from the individual by the medical device while the medical device is connected to the individual, d) initiating database operations, e) a system comprising: at least one device including a hardware processor (from claim 20), and f) a scheduling component to perform the claimed steps.
The claims also include the additional elements steps of 1) “receiving, by an electronic medical record store, from a medical device, information for an individual” and 4) “wherein the individual is treated based at least in part on the event risk score”.
The a) one or more hardware processors, b) an electronic medical record store, d) initiating database operations, e) a system comprising: at least one device including a hardware processor, and f) a scheduling component 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, where there is a lack of description of anything but what may be considered as generic components for these elements including paragraph [0019] where the processor can be a generic component, see MPEP 2106.05(f)).
Also, the c) medical device, wherein the information is collected from the individual by the medical device while the medical device is connected to the individual in these steps and 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 to the abstract idea which amounts to mere data gathering, see MPEP 2106.05(g).
Lastly, the additional element step of 4) “wherein the individual is treated based at least in part on the event risk score” amounts to no more than mere instructions to apply the abstract idea.
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation 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, b) an electronic medical record store, c) a medical device, wherein the information is collected from the individual by the medical device while the medical device is connected to the individual, d) initiating database operations, e) a system comprising: at least one device including a hardware processor, and f) a scheduling component to perform the claimed steps and the additional elements steps of 1) “receiving, by an electronic medical record store, from a medical device, information for an individual” and 4) “wherein the individual is treated based at least in part on the event risk score” 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 a generic computer component that does 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 mathematical concepts and certain method steps of organizing human activity. 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, b) an electronic medical record store, d) initiating database operations, e) a system comprising: at least one device including a hardware processor, and f) a scheduling component to perform the claimed steps, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Additionally, the c) medical device, wherein the information is collected from the individual by the medical device while the medical device is connected to the individual 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” in these steps add 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 information, and transmits this data to system over a network, for example the Internet.
Lastly, the additional element step of 4) “wherein the individual is treated based at least in part on the event risk score” applies the abstract idea in the form of a generic treatment.
Mere instructions to apply an exception using a generic computer component 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 1-24 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Conclusion
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).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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