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 .
Status of Claims
This Office Action is responsive to the applicant response filed May 19, 2026.
Claims 1, 10 and 19 have been amended in the response. No claims have been canceled or newly presented.
Claims 1-19 are currently pending and have been fully examined.
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 1-19 is/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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process (claim 10), a machine (claim 1), and an article of manufacture (claim 19) which is recited as a method, system, and non-transitory computer readable medium that performs the steps and/or functions of:
generate a feature vector that includes a first plurality of values and a second plurality of values,
wherein the first plurality of values corresponds to a respective plurality of static variables that are knowable at a time a patient goes into labor, and
the second plurality of values corresponds to a respective plurality of dynamic variables that are associated with a particular time during labor, the second plurality of values includes at least a most recent cervical dilation value;
provide the feature vector to a trained machine learning model, wherein the trained machine learning model was trained using a plurality of labeled feature vectors associated with a respective plurality of patients associated with one or more known labor outcomes,
wherein each of the plurality of labeled feature vectors (i) included values corresponding to the plurality of static variables and the plurality of dynamic variables associated with a respective patient and (ii) associated with a cervical dilation value in a range that includes the most recent cervical dilation value, and
each of the plurality of labeled feature vectors is associated with an indication of one or more unfavorable outcomes experienced by the respective patient;
receive, from the trained machine learning model, an output indicative of a risk that the patient will experience at least one of the one or more unfavorable outcomes; and
cause information indicative of the risk to be presented to a user to aid the user in determining whether to recommend intrapartum Cesarean delivery for the patient.
Step 2A: Prong 1
When taken individually and as a whole, the steps corresponds to concepts identified as abstract ideas by the courts, such as “certain methods of organizing human activity”, which are interactions between individuals that can include: fundamental economic principles or practices; commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); and managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
The claim is directed to a system to perform the process of providing recommendations based on a patient’s risk, which is performed by the system performing the limitations underlined above.
These describe the system managing the behavior of an individual by providing rules or instructions based on a patient’s level of risk, and the patient’s level of risk is determined by generating feature vectors that include a first and second plurality of values, performing calculations generated by a statistical model that identifies a relationship between the patient’s data and the predicted outcomes. These concepts are used to generate the patient’s risk determination that is used as part of providing the rules or instructions to the user. These concepts relate to the process that a medical professional would follow in making a medical recommendation to recommend intrapartum Cesarean delivery for the patient and thus is considered to be a certain method of organizing human activity.
Step 2A: Prong 2
The claims do not include additional elements that are sufficient to be considered a practical application because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), generally linking the application of the abstract idea to a particular field of use or technological environment (2106.05(h)), or mere instructions to apply it with a computer (MPEP 2106.05(f)), as discussed below.
Mere Instructions to Apply the Abstract Idea Using a Computer
The steps reciting the use of computer components, such as providing the data to the trained machine learning model or receiving the output from the machine learning model, serve as mere instructions to apply the abstract idea using a computer. Mere instructions to apply the abstract idea using a computer are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(f)).
Step 2B
The claims also do not include additional elements that are sufficient to be considered a significantly more than the abstract idea because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), mere instructions to apply it with a computer (MPEP 2106.05(f)), generally linking the application of the abstract idea to a particular field of use or technological environment (MPEP 2106.05(h)), or a well-understood, routine, and conventional limitation (MPEP 2106.05(d)), as discussed below.
The steps addressed above in Step 2A: Prong 2, when considered again under Step 2B are not considered to make the claims amount to significantly more than the abstract idea because those steps, when considered additionally with regards to Step 2B, are still considered to be either insignificant extra-solution activity, mere instructions to apply an abstract idea with a computer, or generally linking the application of the abstract idea to a particular field of use or technological environment, which are types of limitations that are not sufficient to make the claims amount to significantly more than the abstract idea (MPEP 2106.05.I.A).
The steps recited as either being part of the abstract idea or insignificant extra-solution activity are all examples of at least one of: storing and retrieving data from a memory (retrieving data that is stored locally), sending and receiving data over a network (receiving data when that data is from a remote source), electronic recordkeeping, or performing repetitive calculations. All of those functions have been identified as well-understood, routine, and conventional functions of a generic computer that are not significantly more than the abstract idea when claimed broadly or as an extra-solution activity (MPEP 2106.05(d).II).
The recited computer components (e.g., the at least one hardware processor and the non-transitory computer readable medium) are all generically recited components (see specification, par. [0060]-[0061]). Commercially available components, generic computer components, and specially-programmed computer components performing the functions of a generic computer are not considered to be amount to significantly more than the abstract idea (MPEP 2106.05(b)).
When considered as a whole, the components do not provide anything that is not present when the component parts are considered individually. Using the broadest reasonable interpretation, the system as a whole is a system of general purpose computer components that analyze patient data and provide recommendations based on the patient’s determined risk level. This is a general purpose computer system performing the abstract idea and insignificant extra-solution activities through these generically described devices performing well-understood, routine, and conventional functions of a generic computer (MPEP 2106.05(d).II).
Dependent Claim Analysis
Claims 2-9 are ultimately dependent from Claim(s) 1 and includes all the limitations of Claim(s) 1. Therefore, claim(s) 2-9 recite the same abstract idea of certain methods of organizing human activity of claim 1.
Claim 2 recites narrowing details of the trained machine learning model, narrowing the additional element recited in the independent claim rather than presenting a further additional element.
Claims 3 and 7 both recite additional limitations that serve to further describe the mathematical concepts (baseline values, plotting outcomes on graphs using curves to represent average risk scores and risk scores for specific patients experiencing a specific outcome) involved that are used as part of the abstract idea. Therefore, these limitations are also part of the abstract idea. “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.” (MPEP 2106.04.II.A.2).
Claims 4-6 and 9 all recite additional limitations that serve to select by type or source the data to be manipulated by describing the types of data that are to be used when performing the analysis. Selecting by type or source the data to be manipulated is an insignificant extra-solution activity that is not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(g)).
Claim 8 recites additional limitations that amount to performing an additional iteration of the steps performed as part of claim 1. This merely describes performing the steps again using newly acquired data and does not provide any unpredictable results. Therefore, these limitations are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Claims 10-18 are ultimately dependent from Claim(s) 10 and includes all the limitations of Claim(s) 10. Therefore, claim(s) 10-18 recite the same abstract idea of certain methods of organizing human activity of claim 10.
Claims 10-18 all recite additional limitations that are the same or substantially similar to the limitations of claims 2-9, respectively. Therefore, claims 10-18 are rejected under 101 for the same reasons as claims 2-9.
Response to Arguments
35 USC 101 arguments
Applicant's arguments filed May 19, 2026 have been fully considered but they are not persuasive.
Applicant argues that the pending claims are eligible because they clearly do not attempt to tie up “providing recommendations based on a patient’s risk” such that others cannot provide recommendations based on a patient’s level of risk. Applicant cites MPEP 2106.06(a), specifically a robotic arm assembly and an artificial hip prosthesis. Applicant analogizes the pending claims to these examples, in that the pending claims recite meaningful limitations that sufficiently limit the practical application such that the claims do not seek to tie up the alleged judicial exception such that others cannot practice it, pointing to the generation of a feature vector using certain values.
This argument is not persuasive. Per MPEP 2106.04(I), “[w]hile preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) ("We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection"). See also Synopsys v. Mentor Graphics, 839 F.3d at 1150, 120 USPQ2d at 1483; FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 (Fed. Cir. 2016); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Sequenom, 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal Circuit decisions, however, have noted the absence of preemption when finding claims eligible under the Alice/Mayo test. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1350-52, 119 USPQ2d 1236, 1243-44 (Fed. Cir. 2016).
In the instant application, there is an identified abstract idea and there is/are no additional elements that integrates the abstract idea into a practical application. Further, the generation of feature vector that includes values is part of the abstract idea. The “robotic arm” example of MPEP 2106.06(a) is an additional element that would not be part of any abstract idea, even if its use is in operating certain math relationships (which is abstract). Similarly, the artificial hip prosthesis would not be part of the judicial exception, even if the naturally occurring mineral it is coated with is. The pending claims do not recite any additional elements that are analogous to the artificial hip prosthesis or robotic arm examples; this extends to the trained machine learning models to which the feature vector is provided to, as recited in claim 1 and claim 3.
As previously explained, the limitations argued by applicant are among the limitations that comprise the abstract idea recited in the claims, and thus would not provide a practical application, as only additional elements can integrate the abstract idea into a practical application. Furthermore, even if the claims do not attempt to tie up all embodiments of the judicial exception, as argued by applicant, the absence of complete preemption does not demonstrate that a claim is eligible. While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). See MPEP 2106.04.
The claims do not provide any improvement to the functioning of a computer or to any other technology or technical field. The additional elements in combination (as well as individually) do not amount to an inventive concept, e.g., because they are not more than the non-conventional and non-generic arrangement of known, conventional elements.
Applicant argues that the finding that the pending claims are not directed to certain methods of organizing human activity because the claims do not recite any rules or instructions that a person or group of people are to follow to achieve some outcome. Applicant argues that “generate a feature vector that includes a first plurality of values and a second plurality of values” fails to recite any rule or instruction for a person to follow. Applicant argues that the claims do not recite rules or instructions a person would follow, instruct a person on how to do anything, how to act or behave in the world or how to interact with others.
This argument is not persuasive. MPEP 2106.04(a)(2)(II)(C) states that BASCOM is an example of claims that are found to organize human activities while not requiring humans to do anything. Other examples of managing personal behavior recited in a claim include: i. filtering content, BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1345-46, 119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (finding that filtering content was an abstract idea under step 2A). The generation of a feature vector that includes a first and second plurality of values, as well as training a model, receiving an output indicative of a risk, and causing information indicative of a risk to be presented, as well as the limitations detailing what the plurality of values correspond to, are all considered to be part of the process (or series or rules or instructions) that would be followed to perform the process of providing recommendations based on a patient’s risk.
Applicant is also directed to MPEP 2106.04(a)(2)(II)(C): Other examples of managing personal behavior recited in a claim include: iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). In this vein, the Examiner maintains that the limitations asserted as being part of the abstract idea would be part of the process (mental or otherwise) that a medical professional would follow in providing recommendations based on a patient’s risk.
Applicant cites MPEP 2106.04(d) in asserting that “the analysis should take into consideration all the claim limitations” and that the Office’s analysis under Step 2A Prong 2 is improper. Applicant argues that the subject matter of the claims provides improvements to the functioning of a computer or to any other technology or technical field, citing paragraphs 3-9, 42, 46-47, 49-50, 67 and 70 of the specification. Similarly, applicant cites MPEP 2106.05 in arguing that the claims recite “significantly more” than the judicial exception because of (1) improvements to the functioning of a computer; (2) improvements to any other technology or technical field; and (3) other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
This argument is not persuasive. Per MPEP 2106.04(d)(II): The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application.
The use of models to predict a user’s risk of unfavorable labor outcomes is not a technology or technical field. Though applicant points to paragraphs 3-9 of their specification, these paragraphs only broadly discuss the lack of tools and information necessary to accurately determine when intervention via Casarean delivery would be a benefit. Paragraph 8 broadly states that traditional statistical approaches are often not applicable in complex clinical situations. This is not a technology or technical field. Using machine learning techniques in conjunction with intrapartum prediction models is regarded to generally link the machine learning to the abstract idea in an “apply it” manner, as there is no improvement to the machine learning model itself. An “individualized labor chart” is not an improvement to technology or a technical field, nor is a desire or need to more accurately predict outcomes.
Per MPEP 2106.04(d)(I), if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology.
Again citing MPEP 2106.04(d)(I), specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. That is, the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity. It should be noted that while this consideration is often referred to in an abbreviated manner as the "improvements consideration," the word "improvements" in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.
None of the cited paragraphs point to any improvements to the functioning of the computer, technical field or underlying technology. Having “more accurate” predictions as a result of “more successful accounting for dynamic confounders” is not an improvement to the functioning of a computer, technical field or underlying technology. Providing additional or individual data to a model may improve the accuracy of the model, but does not constitute a technical improvement. It is noted that the modeling and predictors are all part of the recited abstract idea set forth in the independent claim. At best, applicant is identifying the novelty of the abstract idea. However, the technical solution is evaluated based on the additional elements, not the abstract idea. The trained machine learning model is the sole additional element recited in the independent claim, with the remainder of the claim being the abstract idea. The trained machine learning model is utilized in an “apply it” manner. The claim language does not provide any specificity regarding how the trained machine learning model operates to obtain the risk score; at most, the claim recites details regarding the data input and the data used in training the machine learning model, but no details regarding the actual operations performed by the trained machine learning model itself. It is not evident how the claims provide any improvement to the machine learning model beyond providing additional and newer/updated data, which is not an improvement to the model itself.
Examples of claims that improve technology and are not directed to a judicial exception include: Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) (claims to a self-referential table for a computer database were directed to an improvement in computer capabilities and not directed to an abstract idea); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial expression animation were directed to an improvement in computer-related technology and not directed to an abstract idea); Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253,1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed to an improvement in computer capabilities and not an abstract idea); Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an improvement in computer technology and not directed to an abstract idea); SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1303 (Fed. Cir. 2019) (claims to detecting suspicious activity by using network monitors and analyzing network packets were found to be an improvement in computer network technology and not directed to an abstract idea). Nothing recited in the pending claims is considered to be analogous to any of these examples of improvements to technology.
Per MPEP 2106.05(II): Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
The additional elements recited in the claims is the hardware processor and machine learning model. These additional elements, when considered individually and in combination, do not: provide an improvement in the functioning of a computer, provide an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, effect a transformation or reduction of a particular article to a different state or thing, implement or use the abstract idea with a particular machine integral to the claim, add a specific limitation other than what is well-understood, routine and conventional activity in the field or adding unconventional steps that confine the claim to a particular useful application (e.g., a non-conventional and non-generic arrangement of various computer components), or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Instead, the hardware processor and machine learning model are used more in line with "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, and generally linking the use of the judicial exception to a particular technological environment or field of use (labor outcomes).
Because none of the identified additional elements provide an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, effect a transformation or reduction of a particular article to a different state or thing, implement or use the abstract idea with a particular machine integral to the claim, address a technical problem by providing a technical solution, the additional elements are not considered to integrate the abstract idea into a practical application, or apply or use the abstract idea in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. Thus, when considered as a whole, the claim does not integrate the abstract idea into a practical application and the claim is not eligible under Step 2A Prong 2 or Step 2B.
35 USC 103 arguments
Applicant argues that Basu and Cossler fails to teach or suggest the plurality of labeled feature vector(s) being “associated with a cervical dilation value in a range that includes the most recent cervical dilation value”, or “wherein each of the plurality of labeled feature vectors (i) included values corresponding to the plurality of static variables and the plurality of dynamic variables associated with a respective patient and (ii) associated with a cervical dilation value in a range that includes the most recent cervical dilation value” without impermissible hindsight reasoning. Applicant argues that Basu is directed to predicting decompensated heart failure risk using static EMR data and dynamically updating wearable cardiovascular sensor streams whereas Cossler is directed to AI-based facilitation of healthcare delivery through monitoring live feedback and generating workflow responses or notifications and real-time tracking interfaces. Applicant argues that the proposed modification of Basu would alter the principle of operation of Cossler’s system by re-architecting it into Basu’s continuous wearable-sensor risk scoring paradigm.
This argument has been fully considered and is persuasive. The prior art rejection of the claims based on the combination of Basu and Cossler has been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 PETER H CHOI whose telephone number is (469)295-9171. The examiner can normally be reached M-Th 9am-7pm.
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/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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