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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/14/2025 has been entered.
Response to Amendment
In the amendment filed 10/14/2025, the following has occurred: 1, 7, 10, and 16 have been amended. Now, claims 1-18 remain pending.
The previous rejections under 35 U.S.C. 112(b) and (d) are withdrawn based on the amendments to the claims.
Claim Rejections - 35 USC § 112
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 7 and 16 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 7 and 16 recite “the alert is an order for an electrocardiogram issued within 10 minutes of patient intake.” Paragraph 0021 of the specification identifies 10 minutes as a critical window from arrival of a patient to diagnosing the patient, including conducting an ECG. Paragraph 0026 explains that alerts can flag medical professionals that an incoming patient requires an ECG. However, there is no description in the specification of the timing of the alert. Therefore, the limitation “the alert is an order for an electrocardiogram issued within 10 minutes of patient intake” is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention.
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 1-18 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; provide only the preliminary information to a model trained to predict an emergency medical condition requiring immediate treatment; obtain a likelihood that the patient is suffering from an emergency medical condition from the predictive 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; storing the preliminary information in an EHR; providing only the preliminary information to a model trained to predict an emergency medical condition requiring immediate treatment; obtaining a likelihood that the patient is suffering from an emergency medical condition from the 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. For example, the claims encompass manually obtaining patient data during patient intake, applying a model (i.e. rules or instructions) 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 2-9 and 11-18 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2-5 and 11-14 further define the patient data and model. With regard to claims 4-5 and 13-14, the model encompasses Mathematical concepts in the form of a mathematical formula or equation. This is also an 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 1-9, 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 10-18, 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.
Claims 9-18, 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” and “a model trained to predict.” The “machine learning” limitations are recited at a high degree of generality without any limitations as to scope or use. Similarly, “a model trained to predict” is also recited at a high degree of generality without any limitations as to the scope of any training of the model. 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 8-12, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho, US Patent Application Publication No. 2022/0369937 in view of Makram, US Patent Application Publication No. 2019/0180868.
As per claim 1, Cho teaches a predictive electronic health record (EHR) system, comprising: a processor (see paragraph 0046); and a memory, the memory containing an EHR management application which configures the processor (see paragraph 0046) to: obtain preliminary information about a patient via a terminal (see paragraph 0065; patient input); store the preliminary information in an HER (see paragraph 0065; patient input is stored in EHR); provide only the preliminary information to a model trained to predict an emergency medical condition requiring immediate treatment (see paragraphs 0083 and 0089; patient parameters are applied to rules, comprising a machine learning model, to predict an emergency medical condition); obtain a likelihood that the patient is suffering from an emergency medical condition from the predictive model (see paragraph 0022; predicts likelihood that patient is experiencing an acute health event); and automatically provide an alert when the likelihood exceeds a predetermined threshold (see paragraph 0082; if acute health event is detected, generates an alert; paragraph 0084 describes that this may be based on comparison of a risk score in the form of a percentage likelihood of the acute health event to a threshold).
Cho describes the benefits of the initial assessment of the patient (see paragraph 0111; provides patient-specific care recommendations to EMS that arrive on the seen of a patient). However, Cho does not explicitly describe the preliminary information as being obtained during patient intake. Makram teaches obtaining preliminary information about a patient during patient intake (see paragraph 0045; a patient entering the emergency department is first assessed using a set of data sensors that gather an initial set of patient biometric and sensor data). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to obtain the preliminary information about a patient during intake in the system of Cho with the motivation of improving emergency department efficiency (see paragraph 0004 of Makram).
As per claim 2, Cho and Makram teaches the system of claim 1 as described above. Cho further teaches the preliminary information comprises: age, sex, and at least one chief complaint (see 0065; age and gender, certain patient input data, such as symptom data, could be a chief complaint).
As per claim 3, Cho and Makram teaches the system of claim 1 as described above. Cho further teaches the model is a logistic regression (see paragraph 0078; describes various types of regression models).
As per claim 8, Cho and Makram teaches the system of claim 1 as described above. Cho further teaches the predetermined threshold is between 0.0038 and 0.0044 (see paragraph 0084; compares the risk score as a percentage to a threshold. The recited threshold is further defining the provide step of claim 1 for which a an alert is provided when the threshold is exceeded. Since Cho teaches a percentage exceeding the threshold, this would exceed a number of .0044).
As per claim 9, Cho and Makram teaches the system of claim 1 as described above. Cho further teaches the model is a machine learning model (see paragraph 0079; the rules configure different machine learning models).
Claims 10-12 and 17-18 recite substantially similar method limitations to system claims 6-7 and, as such, are rejected for similar reasons as given above
Claim(s) 4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho, US Patent Application Publication No. 2022/0369937 in view of Makram, US Patent Application Publication No. 2019/0180868 and further in view of Reuter et al., Predicting acute coronary syndrome in males and females with chest pain who call an emergency medical communication centre.
As per claim 4, Cho and Makram teaches the system of claim 1 as described above. Cho does not explicitly teach the logistic regression is the recited formula. Initially, it is noted that in disclosing the use of various types of regression models (paragraph 0078), this includes a formula of the type of a log of y intercept plus a series of variables with coefficients. However, Cho does not describe the specific variables of claim 4 in this regression formula. Reuter teaches a logistic regression model with variables that include chest pain, other complaints, age, and gender with corresponding regression coefficients (see page 5, Model development, and Table 2). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to employee these logistic regression variables in the system of Cho, since Cho discloses regression models for determining the likelihood, to build upon diagnosis of patients with chest pain (see page 1, Conclusion of Router).
Claim 13 recites substantially similar method limitations to system claim 4 and, as such, is rejected for similar reasons as given above
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho, US Patent Application Publication No. 2022/0369937 in view of Makram, US Patent Application Publication No. 2019/0180868 and further in view of Li, US Patent Application Publication No. 2022/0093259.
As per claim 6, Cho and Makram teaches the system of claim 1 as described above. Cho further teaches the emergency medical condition is myocardial infarction (see paragraph 0029; acute health events include myocardial infarction). Cho does not explicitly teach the form of myocardial infarction is STEMI. Li teaches classifying myocardial infarction prediction into STEMI and non-STEMI (see paragraph 0069). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to determine that the predicted event is STEMI from this classification with the motivation of providing a more accurate prediction (see paragraph 0069 of Li).
Claim 15 recites substantially similar method limitations to system claim 6 and, as such, is rejected for similar reasons as given above.
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho, US Patent Application Publication No. 2022/0369937 in view of Makram, US Patent Application Publication No. 2019/0180868 and further in view of Li, US Patent Application Publication No. 2022/0093259 and Coyne et al., Improving Door-to-balloon Time by Decreasing Door-to-ECG time for Walk-in STEMI Patients.
As per claim 7, Cho, Makram, and Li teaches the system of claim 6 as described above. Cho further teaches the alert is an order for an electrocardiogram (see paragraph 0101; predicted event may alert clinician to send patient ECG data). Cho does not explicitly teach the order for an electrocardiogram is within 10 minutes of patient intake. Coyne describes the benefits of performing an ECG within 10 minutes of a patient arrival (see page 185, Background). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to order the ECG in Cho within 10 minutes of intake with the motivation of improving the change of positive health outcomes (see Background of Coyne).
Claim 16 recites substantially similar method limitations to system claim 7 and, as such, is rejected for similar reasons as given above.
Distinguishing Subject Matter
Claims 5 and 14 distinguish over the prior art. The following is a statement of reasons for the indication of distinguishing subject matter: The primary reason that claims 5 and 14 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, defined in claims 5 and 14, 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 03/17/2025, Applicant argues (1) the claims integrate the abstract idea into a practical application by transforming the preliminary information into a prediction and automatically providing an alert, similar to published Example 42; (2) automatically providing an alert to issue an order for an ECG within the 10 minute window integrates the abstract idea into a practical application; (3) Cho does not teach obtaining the preliminary information during patient intake; (4) Li classifies a myocardial infarction as STEMI or not STEMI but does not teach how to predict a STEMI; (5) Cho does not teach obtaining an ECG via an order.
In response to argument (1), the only additional elements recited to carry out these steps are a processor, memory, and terminal (claim 1) or a model and terminal (claim 10) as well as automatically providing the alert. These additional elements are recited at a high degree of generality and are merely utilized as a tool to implement the abstract idea. Specifying that one of the steps is performed “automatically” simply provides an operation of any general purpose computing device. In Example 42, the claim was identified as reciting “a combination of additional elements” that integrated the abstract idea into a practical application. Such a combination of additional elements is not present in the pending claims. Applicant argues that the claims similarly recite transforming the preliminary information into a prediction. However, the claims do not recite a data transformation similar to that of Example 42. The claims recite obtaining a likelihood that the patient has an emergency medical condition based on the preliminary information. This is the type of analysis performed by a doctor in a hospital and is not at all related to transforming non-standard data to standardized data (and transforming data from multiple different sources as in Example 42). Therefore, the examiner respectfully maintains that the abstract idea is not integrated into a practical application.
In response to argument (2), while ordering and ECG within 10 minutes of a patient intake is clearly important to the outcome of the patient, as explained in the background of the specification, along with the newly cited Coyne reference, this recited limitation does not provide any technical improvement I the field. There is no improvement to the alerting itself or any other technical feature. Rather, the claim relies on generic computer features to execute this process that results in an ECG being ordered within 10 minutes of intake. Therefore, the examiner respectfully maintains that the abstract idea is not integrated into a practical application.
Applicant’s argument (3) is moot in view of the new grounds of rejection set forth above.
In response to argument (4), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Cho teaches predicting an acute health condition, which can include a myocardial infarction (see paragraph 0029). Li teaches classifying a myocardial infarction as STEMI or not STEMI. Therefore, when combined, classifying a predicted myocardial infarction as STEMI is encompassed by the limitation of claim 6.
In response to argument (5), as set forth in the above rejections, the alert of Cho may indicate to a doctor that an ECG should be sent. Sending ECG data involves the order of an ECG. Additionally, this rejection is based on the combination with Coyne with identifies a 10 minute window for performing an ECG. Therefore, based on the combination of references, the examiner respectfully submits that claim 7 encompasses these teachings.
Conclusion
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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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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