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 03/17/2025, the following has occurred: 1 and 10 have been amended. Now, claims 1-18 remain pending.
The previous rejections under 35 U.S.C. 112(b) are withdrawn based on the amendments to the claims. However, based on the amendments, new rejections under 35 U.S.C. 112(b) and 112(d) are set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites “the model is a logistic regression.” Claim 10, upon which claim 12 depends via claim 11, has been amended to recite “a machine learning model” rather than simply “a model.” Therefore, the antecedent basis for “the model” is unclear and indefinite.
Claims 13 and 14 are rejected based on their dependencies on claim 12.
Claim 18 recites “the model is a machine learning model.” Claim 10, upon which claim 18 depends, has been amended to recite “a machine learning model” rather than simply “a model.” Therefore, the antecedent basis for “the model” is unclear and indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 18 is dependent on claim 10 and recites “wherein the model is a machine learning model.” Claim 10 recites “providing only the preliminary information to a machine learning model.” Therefore, claim 18 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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; 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; 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 providing an alert when the likelihood exceeds a predetermined threshold.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, 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, 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. But for the recitation of generic computer components, 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, but for the recitation of generic computer components. 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,” “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,” “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 machine learning model trained to predict.” The “machine learning” limitations are 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. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-12, and 17-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cho, US Patent Application Publication No. 2022/0369937.
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 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).
As per claim 2, Cho 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 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 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 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 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.
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 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 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) 6-7 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho, US Patent Application Publication No. 2022/0369937 in view of Li, US Patent Application Publication No. 2022/0093259.
As per claim 6, Cho 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).
As per claim 7, Cho 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).
Claims 15-16 recite substantially similar method limitations to system claims 6-7 and, as such, are 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 providing an alert of a high priority patient based on preliminary information, similar to published Example 42; (2) the claims only use preliminary information to predict an emergency medical condition which distinguishes over Cho which relies on sensed data, patient input, and/or EHR data.
In response to argument (1), as described in the above rejections, providing an alert when it is predicted that a user has an emergency medical condition is part of the abstract idea. The only additional elements recited to carry out these steps are a processor, memory, and terminal (claim 1) or a machine learning model and terminal (claim 10). These additional elements are recited at a high degree of generality and are merely utilized as a tool to implement the abstract idea. 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. Therefore, the examiner respectfully maintains that the abstract idea is not integrated into a practical application.
In response to argument (2), it is first noted that that the “preliminary information” recited in the independent claims is only defined as “preliminary information about a patient.” Therefore, these recitations encompass any patient information. Dependent claims 2 and 11 further recite “the preliminary information comprises: age, sex, and at least one chief complaint.” The scope of this limitation identifies age, sex, at least one chief complaint, and any other information because “comprises” is an open transitional term. Therefore, even if Cho teaches providing sensed data (along with age, sex, chief complaint), the recitations do not distinguish over this teaching. Accordingly, the examiner respectfully maintains that claims 1 and 10 are anticipated by Cho.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gencer et al., Ruling out coronary heart disease in primary care patients with chest pain: a clinical prediction score, discloses estimating probability of coronary heart disease based on preliminary health data, including age, gender, and chief complaint.
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.
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, 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.
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.
C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683