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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 1-21 are related to a method. Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Independent claim 1 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 1 recites:
A method for determining risk of an asthma exacerbation in a patient with non-eosinophilic asthma (NEA), the method comprising:
receiving patient data for the patient having a test result indicating an eosinophilic blood count below a predetermined threshold, wherein the patient data comprises diagnostic data relating to the patient, laboratory data relating to the patient, pharmaceutical data relating to the patient, and procedure data relating to the patient;
applying a trained model to the patient data to determine risk of an asthma exacerbation in the patient; and
generating a notification, via a display device, indicating the risk of the asthma exacerbation in the patient.
The Examiner submits that the foregoing underlined limitations constitute a “mental process”, as the following abstract limitations are related to observations, evaluations and judgments that can be practically performed in the human mind:
“Determine” risk of an asthma exacerbation in the patient, which recites an abstract step of analysis of the received patient data to make a determination of the risk.
Accordingly, the claim recites the steps for determining risk of an asthma exacerbation in a patient with non-eosinophilic asthma that can practically be performed in the human mind.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., trained model) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 2 recites further abstract limitations describing the determined risk as occurring within a time period of a year or month, further describing the abstract idea. Claims 4,5 recite further abstract limitations of analysis by determining the risk group of the patient including low, medium, and high-risk groups as claimed, further describing the abstract idea. Claims 6, 7 recite further abstract limitations of analysis of the diagnostic data to generate an indication of whether or not the patient has been diagnosed in the categories and where the categories are defined by ICD 10 codes, further describing the abstract idea. Claims 8, 9 recites further abstract limitations of analysis of the laboratory data to determine a statistical measure of the tests of the patient, where the statistical measure includes minimum/maximum/mean/difference as claimed, further describing the abstract idea. Claim 10 recites further abstract limitations of analysis of removing tests with no data, splitting the LOINC, calculating with the LOINC and excluding the tuples with standard deviation count greater than a predetermined number, further describing the abstract idea. Claim 11 recites further abstract limitations of analysis of the pharmaceutical data to determine a count of unique medications prescriptions prescribed to the patient, further describing the abstract idea. Claim 12 recites further abstract limitations of analysis of the pharmaceutical data of determining a count of prescriptions as claimed, further describing the abstract idea. Claim 13 recites further abstract limitations of analysis of the pharmaceutical data of generating an indication of if the patient being prescribed to the medications, further describing the abstract idea. Claim 15 recites further abstract limitations of analysis of determining a count of procedures for the patient in an identified subset of procedure group types, further describing the abstract idea. Claims 17, 18 recites further abstract limitations of analysis using a feature vector with patient data and metadata, where the data includes demographic data, further describing the abstract idea.
Patent Subject Matter Eligibility Test: Step 2A- Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method for determining risk of an asthma exacerbation in a patient with non-eosinophilic asthma (NEA), the method comprising (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)):
receiving patient data for the patient having a test result indicating an eosinophilic blood count below a predetermined threshold, wherein the patient data comprises diagnostic data relating to the patient, laboratory data relating to the patient, pharmaceutical data relating to the patient, and procedure data relating to the patient; (merely data gathering steps as noted below, see MPEP 2106.05(g) and buySAFE, Inc. v. Google, Inc.)
applying a trained model to the patient data to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) determine risk of an asthma exacerbation in the patient; and
generating a notification, via a display device, indicating the risk of the asthma exacerbation in the patient (merely post solution activity as noted below, see MPEP 2106.05(g) and buySAFE, Inc. v. Google, Inc.).
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of the overall method implemented on a computer, and applying a trained model to the patient data, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0052, 0053] of the Applicant’s Specification recites the use of generic processors and memory to carry out the method. [0026, 0040] recites the use of a generically trained model. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Regarding the additional limitation of receiving patient data for the patient having a test result indicating an eosinophilic blood count below a predetermined threshold, wherein the patient data comprises diagnostic data relating to the patient, laboratory data relating to the patient, pharmaceutical data relating to the patient, and procedure data relating to the patient, this is merely pre-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [0028] of the Applicant’s Specification recites the step of receiving patient data from data sources via a network. The step of receiving data is used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities.
Regarding the additional limitation of generating a notification, via a display device, indicating the risk of the asthma exacerbation in the patient, these are merely post-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g)). [0079] of Applicant’s specification recites the use of the display device of the client device for merely outputting the abstract idea via the notification, and therefore recites impractical application.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to determine risk of an asthma exacerbation in a patient with non-eosinophilic asthma, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claim 2 recites further additional elements of the insignificant post solution activity of displaying the notification. Claim 3 recites further additional elements describing the insignificant pre solution activity further describing the predetermined threshold, however this still recites steps for the data gathering. Claim 10 recites further additional elements describing the pre solution activity as further describing the laboratory data being defined as LOINC, however this is still just a data gathering step. Claim 14 recites further additional elements further describing the pre solution activity as further describing the pharmaceutical data as being associated with a NDC, however this is still a data gathering step. Claim 16 recites further additional elements further describing the pre solution activity as further describing the procedure data as being associated with a CPT code, however this is still a data gathering step. Claim 19 recites further additional elements describing the post solution activity including the use of the display that is a part of a mobile device, however this still recites insignificant post solution activity. Claim 20 recites further additional elements of training the model using patient data with generic steps that do not recite technical improvement and amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. Claim 21 recites further additional elements of the machine learning comprising a XGBoost algorithm, however the implementation is recited in a generic manner that amounts to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components.
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent claim does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding the additional limitation of the overall method implemented on a computer, and applying a trained model to the patient data, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0052, 0053] of the Applicant’s Specification recites the use of generic processors and memory to carry out the method. [0026, 0040] recites the use of a generically trained model. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception.
Regarding the additional limitation of receiving patient data for the patient having a test result indicating an eosinophilic blood count below a predetermined threshold, wherein the patient data comprises diagnostic data relating to the patient, laboratory data relating to the patient, pharmaceutical data relating to the patient, and procedure data relating to the patient, this is merely pre-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)”). [0028] of the Applicant’s Specification recites the step of receiving patient data from data sources via a network. The step of receiving data is used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities and does not recite significantly more than the judicial exception. The use of a network to transmit the data for the pre solution activity recites well understood, routine, and conventional activity.
Regarding the additional limitation of generating a notification, via a display device, indicating the risk of the asthma exacerbation in the patient, these are merely post-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)”). [0079] of Applicant’s specification recites the use of the display device of the client device for merely outputting the abstract idea via the notification, and therefore recites impractical application and does not recite significantly more than the judicial exception. Transmission of the data for display on the client device as in [0025, 0079] recites well understood, routine, and conventional activity.
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 1-21 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 1-21 are rejected under 35 USC 103 as being unpatentable over WO 2021148966 A1 to Bacher et al. (“Bacher”) in view of “Individualised risk prediction model for exacerbations in patients with severe asthma: protocol for a multicentre real-world risk modelling study” to Lee et al. (“Lee”):
Regarding claim 1:
Bacher teaches a method for determining risk of an asthma exacerbation in a patient with [asthma], the method comprising: ([0015]- overall method described for predicting a probability of a patient experiencing an exacerbation of asthma.)
…
receiving patient data … wherein the patient data comprises diagnostic data relating to the patient, laboratory data relating to the patient, pharmaceutical data relating to the patient, and procedure data relating to the patient; ([0018]- input patient data used for the prediction of exacerbation, [0020]- diagnostic data relating to the patient used as input patient data, [0022]- test measurements (interpreted as the laboratory data) relating to the patient used as input patient data, [0023]- pharmaceutical data relating to the patient used as input patient data, [0036]- tracking of variables including patient’s hospitalization used as input variables (interpreted as procedure data relating to the patient).)
applying a trained model to the patient data to determine risk of an asthma exacerbation in the patient; and ([0026, 0028]- use of a trained machine learning algorithm with the input patient data to generate a prediction model to quantify the risk of an asthma exacerbation)
generating a notification, via a display device, indicating the risk of the asthma exacerbation in the patient. ([0016]- output of the prediction risk can be generated on a display as an alert.)
Bacher does not teach:
risk of exacerbation for the patient with a test result indicating an eosinophilic blood count below a predetermined threshold and has non-eosinophilic asthma
Lee however teaches before the effective filing date of the current invention teaches of a risk prediction model for determining risk of exacerbation for patients with asthma [Page 1, ‘Abstract’], including patients with non-type 2 asthma that are classified [Page 4, ‘Clinical utility assessment’] (where the patients classified as non-type 2 asthma are patients with NEA, and it can be interpreted that a patient with NEA will have blood tests with lower-than-normal eosinophilic blood counts below a predetermined threshold).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have the risk of exacerbation determined for the patient with NEA as in Lee in the method of Bacher with the motivation of providing better risk assessment for patients with NEA as taught by Lee over that of Bacher.
Regarding claim 2:
Bacher/Lee teaches all of the limitations of claim 1. Bacher further teaches wherein the notification indicates that the patient is at risk of the asthma exacerbation within a time period, wherein the time period comprises one of a year or a month. ([0019]- years for the prediction)
Regarding claim 6:
Bacher/Lee teaches all of the limitations of claim 1. Bacher further teaches pre-processing the diagnostic data to generate, for each of a plurality of diagnostic categories, an indication of whether or not the patient has been diagnosed with one or more of the plurality of diagnostic categories. ([0025, 0026]- model is trained using data indicating a diagnosis for asthma)
Regarding claim 7:
Bacher/Lee teaches all of the limitations of claim 6. Bacher further teaches wherein the plurality of diagnostic categories are defined by a International Classification of Diseases 10th Revision (ICD-10) code system. ([0022]- use of ICD 10 codes)
Regarding claim 11:
Bacher/Lee teaches all of the limitations of claim 1. Bacher further teaches pre-processing the pharmaceutical data to determine a count of unique medication prescriptions prescribed to the patient. ([0023]- prescriptions)
Regarding claim 12:
Bacher/Lee teaches all of the limitations of claim 11. Bacher further teaches wherein pre-processing the pharmaceutical data further comprises determining a count of total prescriptions, a count of prescriptions of asthma rescue medication, and a count of prescriptions of asthma anti-body medicine. ([0023]- amount of prescriptions)
Regarding claim 13:
Bacher/Lee teaches all of the limitations of claim 11. Bacher further teaches wherein pre-processing the pharmaceutical data further comprises generating, for each of a plurality of medication prescriptions, an indication of whether the patient is prescribed each of the plurality of medication prescriptions. ([0023]- prescribed to patient)
Regarding claim 19:
Bacher/Lee teaches all of the limitations of claim 1. Bacher further teaches wherein one or more of a mobile device of the patient or a healthcare provider of the patient comprise the display. ([0090]- use of personal device with display.)
Claims 3-5, 8-10, 14-18, and 20-21 are rejected under 35 USC 103 due to their dependency to claim 1, however the cited references do not teach the limitations of these claims.
The following references have been considered as relevant, however have not been used in the above rejections:
US-20210005321-A1 to Hwang teaches of predicting risk outcomes for a patient by analyzing medical data.
US 20210196194 A1 to Weffers-Albu et al. teaches of generating a exacerbation risk score for a respiratory disease of a patient by analyzing data from sensors and coughing events.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINE SIOZOPOULOS whose telephone number is (571)272-6719. The examiner can normally be reached Monday-Friday, 8AM-5PM EST.
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/CONSTANTINE SIOZOPOULOS/
Primary Examiner
Art Unit 3686
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