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 the amendment filed 05/26/2026, the following has occurred: 1 and 10 have been amended and claims 2-5, 11-14, and 18 have been canceled. Now, claims 1, 6-10, and 15-17 are pending.
The previous rejections un 35 U.S.C. 103 and 112(a) are withdrawn based on the amendments and remarks.
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, 6-10, and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claim 1 recites obtain preliminary information about a patient, wherein the preliminary information is obtained during patient intake, wherein the preliminary information comprises: age, sex, and at least one chief complaint; provide only the preliminary information to a logistic regression model trained to predict an emergency medical condition requiring immediate treatment, wherein the logistic regression is log[p/1-p] = intercept + b1*chest pain + b2*other ACS chief complaints + b3*age at visit + b4*gender, and wherein values for constants in the logistic regression are: -5.5 < intercept < -5.2; -3.2 < b1 < -2.9; -0.33 < b2 <-0.3; 0.03 < b3 <0.055; and -0.66 < b4 <-0.62; chest pain equals 1 when the at least one chief complaint comprises chest pain; chest pain equals 0 when the at least one chief complaint does not comprise chest pain; and other ACS chief complaints equals 1 when the at least one chief complaint comprises at least one of: chest pain, shortness of breath, weakness, fall, abdominal pain, palpitations, irregular heartbeat, dizziness, altered mental status, nausea, vomiting, syncope, near syncope, abnormal lab or test, arm pain, shoulder pain, hypotension, neck pain, hypertension, heart problem, and cardiac arrest; obtain a likelihood that the patient is suffering from an emergency medical condition from the logistic regression model; and provide an alert when the likelihood exceeds a predetermined threshold.
Claim 10 recites obtaining preliminary information about a patient, wherein the preliminary information is obtained during patient intake, wherein the preliminary information comprises: age, sex, and at least one chief complaint; providing only the preliminary information to a logistic regression model trained to predict an emergency medical condition requiring immediate treatment, wherein the logistic regression is log[p/1-p] = intercept + b1*chest pain + b2*other ACS chief complaints + b3*age at visit + b4*gender, and wherein values for constants in the logistic regression are: -5.5 < intercept < -5.2; -3.2 < b1 < -2.9; -0.33 < b2 <-0.3; 0.03 < b3 <0.055; and -0.66 < b4 <-0.62; chest pain equals 1 when the at least one chief complaint comprises chest pain; chest pain equals 0 when the at least one chief complaint does not comprise chest pain; and other ACS chief complaints equals 1 when the at least one chief complaint comprises at least one of: chest pain, shortness of breath, weakness, fall, abdominal pain, palpitations, irregular heartbeat, dizziness, altered mental status, nausea, vomiting, syncope, near syncope, abnormal lab or test, arm pain, shoulder pain, hypotension, neck pain, hypertension, heart problem, and cardiac arrest; obtaining a likelihood that the patient is suffering from an emergency medical condition from the logistic regression model; and automatically providing an alert when the likelihood exceeds a predetermined threshold.
These limitations, as drafted, given the broadest reasonable interpretation encompass managing personal behavior by following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity and numerical formulae or equations and mathematical calculations which are subgroupings of Mathematical Concepts. For example, the claims encompass manually obtaining patient data during patient intake, applying a logistic regression model (i.e. calculations using a numerical equation) to determine a likelihood that the patient is at risk of an emergency medical condition, and manually alerting someone of the emergency. Such manual steps encompass Certain Methods of Organizing Human Activity.
Claims 6-9 and 15-17 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. Claims 6-7 and 15-16 further define the medical condition and alert. Claims 8 and 17 further define the threshold for determining the emergency condition. As explained above, these manual steps encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with adding elements similar to adding the words “apply it” to the abstract idea, and generally linking the abstract idea to a particular technological environment.
Claims 1 and 6-9, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “a processor; and a memory, the memory containing an EHR management application which configures the processor,” the processor “automatically provides an alert,” “a terminal,” “store the preliminary information in an EHR”
Claims 10 and 15-17, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “a terminal,” “automatically providing an alert,” “storing the preliminary information in an EHR.”
The written description discloses that the recited computer components encompass generic components including “any computer interface such as (but not limited to) desktop computers, laptops, tablet computers, smart phones, and/or any other device capable of enabling input for creation of EHRs as appropriate to the requirements of specific applications” (see paragraph 0026). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claim 9, directly or indirectly, recite the following additional elements similar to adding the words “apply it” to the abstract idea and generally linking the abstract idea to a particular technological environment: “the model is a machine learning model” The “machine learning” limitation is recited at a high degree of generality without any limitations as to scope or use. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (see MPEP 2016.05(h) and Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 120 USPQ2d 1201 (Fed. Cir. 2016)).
Storing and retrieving information in memory (e.g. storing data in an HER) has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. The additionally elements considered in combination with all of the recited limitations amount to no more than generic computer components configured to carry out the abstract idea. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Distinguishing Subject Matter
Claims 1, 6-10, and 15-17 distinguish over the prior art. The following is a statement of reasons for the indication of distinguishing subject matter: The primary reason that claims1, 6-10, and 15-17 distinguish over the prior art is using a logistic regression based on age, gender, chest pain, and another chief complaint, with a specific set of regression coefficients, unique to each variable as defined in the claims to determine a likelihood that a patient has an emergency medical condition. The closest prior art (Cho and Reuter) discloses applying a logistic regression model to predict the likelihood that a patient has an emergence medical event. The prior art also teaches using the variables of age, gender, chest pain, and another chief complaint to determine the likelihood. However, the prior art does not disclose the specific set of logistic coefficients applied to the individual variables in a logistic regression model.
Response to Arguments
In the remarks filed 05/26/2026, Applicant argues (1) paragraphs 0021, 0025, 0026, and 032 provide adequate support for the subject matter recited in claims 7 and 16; (2) the recitation of the specific logistic regression formula integrates the abstract idea into a practical application similar to that in Diamond v. Diehr; (3) the claims recite specific machine learning model parameters that improve how the model itself operates, similar to that in Ex Parte Desjardines; (4) the recited logistic regression model is integrated into a practical application by triggering medical intervention.
In response to argument (1), the rejection under 35 U.S.C. 112(a) has been withdrawn, rendering this argument moot.
In response to argument (2), the reason why the claims in Diehr integrates the abstract idea (of a mathematical equation in that case) into a practical application was the inclusion of the combined limitations of “installing rubber in a press, closing the mold, constantly measuring the temperature in the mold, and automatically opening the press at the proper time” (MPEP 2106.05(e)). This was found to sufficiently limit the use of the Arrhenius equation to the practical application of molding rubber products. In contrast, the only recited outcome of the recited equation is automatically providing an alert. At most, this provides no more than insignificant extra-solution activity because the use of the recited equation does not provide technical improvements to alerting. The claims do not recite any equivalent to automatically opening a rubber molding press recited in Diehr.
In response to argument (3), the logistic regression model recited in the claims is clearly defined in the claims as a mathematical equation. As explained above, it is not merely the given parameters of the equation that integrates the equation into a practical application, but the combination of limitation that provides a technical improvement, such as automatically opening a rubber molding press at a specific time. Additionally, the recited parameters do not provide an improvement to a machine learning model because the logistic regression model simply functions as it is intended to. Rather, the improvement of the recited parameters is in identifying of patients with a certain condition. The claims recite this identification being conveyed via an alert. However, generating an alert does not integrate the abstract idea into a practical application for the reasons explained above.
In response to argument (4), as explained above, the result of the recited equation is the generation of an alert. This may be used by an individual to take some medical action, but it does not improve a treatment itself. For example, paragraph 0032 describes an identified patient being immediately moved to treatment, but does not describe the administering of any particular treatment. Therefore, the examiner respectfully maintains that the claims do not integrate the abstract idea into a practical application for the reasons explained above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Aoki, US Patent Application Publication No. 2014/0025394, discloses tracking patient status from arrival at a hospital, including diagnosing STEMI.
Dreyer, US Patent Application Publication No. 2018/0314802, discloses tracking patient arrival, demand, and capacity at a hospital and monitoring patient acuity including STEMI.
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 C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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