DETAILED ACTION
This office action is based on the claim set filed on 12/29/2025.
Claims 1-2, 4-8, 10-14, 17, 19-20, and 22 have been amended.
Claim 3, 9, 15-16, 18, and 21 have been canceled.
Claim 23 is new.
Claims 1-2, 4-8, 10-14, 17, 19-20, and 22-23 are currently pending and have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
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.
Claim 1-2, 4-8, 10-14, 17, 19-20, and 22-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-2, 4-8, 10-14, 17, 19-20, and 22-23 are drawn to a method and are within the four statutory categories (i.e., a machine and a process). Claims 1-2, 4-8, 10-14, 17, 19-20, and 22-23 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for predicating unplanned cesarean delivery. Collecting a mother and fetal data to estimate delivery method are steps that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Metal Process that can be performed using human mind with the aid of pencil and paper.
Independent Claim 1 recites the steps of:
“A method of treating a target mother pregnant with a target fetus for unplanned Cesarean Delivery (uCD), comprising:
Using at least one processor operatively coupled to a display and to a network interface and/or to a data storage device for:
creating or receiving a multi-record training dataset, wherein a record comprises:
adapting at least one fetal biometric parameter depicting a historical gestational age of a sample fetus obtained by an ultrasonography device, to an adapted at least one fetal biometric parameter depicting a current gestational age at time of admission of a sample mother of the fetus to labor
at least one personal parameter of a sample mother of the sample fetus,
a ground truth indicating whether a birth of the sample fetus by the sample mother was an uCD during attempted vaginal delivery or via vaginal delivery;
wherein the at least one fetal biometric parameter, the at least one personal parameter, and the ground truth, are accessed by the at least one processor via the network interface and/or the data storage device;
training the machine learning model on the multi-record training dataset for generating an outcome indicating likelihood of uCD for a target mother in response to an input of at least one adapted fetal biometric parameter of a target fetus of the target mother at a gestational age at time of admission to labor and at least one personal parameter of the target mother
storing the trained machine learning model on the data storage device and/or on a server accessed via the network interface and/or the data storage device
accessing at least one fetal biometric parameter of the target fetus of the target mother obtained by the ultrasonography device at a historical gestational age of the target fetus prior to a current gestational age of the target fetus at time of admission to labor;
wherein the at least one fetal biometric parameter of the target fetus is accessed by the at least one processor via the network interface and/or the data storage device or entered via a user interface presented on the display
computing an adapted at least one fetal biometric parameter by adapting the at least one fetal biometric parameter obtained at the historical gestational age to a predicted value of the at least one fetal biometric parameter at the current gestational age at the time of admission to labor;
feeding the adapted at least one fetal biometric parameter of the target fetus and at least one personal parameter of the target mother into the machine learning model generated from the training;
obtaining an indicating likelihood of uCD for the target mother as an outcome of the machine learning model; and
presenting the indication within a graphical user interface presented on the display;
in response to the likelihood being above a threshold indicating high likelihood of uCD; performing a cesarean delivery surgical procedure on the target mother”.
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper reciting an abstract idea for Mental Process along but for the recitation of generic computer components. For example, the limitations encompass a user the ability to collect a mother and fetal information and input the data into a model to provide outcomes indicating a likelihood of unplanned cesarean delivery (CD) and labeling the delivery mode, which are steps that that could have been performed by a human to implement the abstract idea and are steps reciting mental process that could have been performed using a human mind with aid of pen and paper but other than the mere nominal recitation of "processor, machine learning model", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, 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, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, machine learning model, ultrasound/ultrasonography device, network interface, storage device, user interface, display, server” that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions for determining likelihood of delivery mode (e.g., unplanned CD) such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), “i.e., training the machine learning model..., storing the trained machine learning model ... , feeding the adapted at least one fetal biometric parameter ... into the machine learning model, in the claims is recited at a high level of generality and is described in the specification in an arbitrary form without disclosing a specific algorithm using available data for allowing the model to learn patterns and relationships within the data and implement it to perform the claimed function”, generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h) (i.e., refereeing to the use of cesarean delivery “performing a cesarean delivery surgical procedure …”), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] 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. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), generally linking the use of the judicial exception to a particular technological environment or field of use, see MPEP 2106.05(h) (i.e., refereeing to the use of cesarean delivery “performing a cesarean delivery surgical procedure …”), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an 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."). The claims are not patent eligible.
Dependent Claims 2, 4-8, 10-14, 17, 19-20, and 22-23 include all of the limitations of claim(s) 1 and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2, 4-8, 12-13, 19 and 23, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process but for the recitation of generic computer components. For example, calculating a percental..., is/are Mathematical Concepts. The claims are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 10-11, 14, 17, and 20, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, “Mental Process”, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. The claims recite additional elements “ultrasonography device, machine learning model” that implement the identified abstract idea. These hardware components are recited at a high level of generality to perform the steps that amounts to no more than the words "apply it" with a computer because it appears to intend to do so, which would still amount to mere instructions to apply the exception using generic computer components, “i.e., applying a ready trained machine learning model recited in the claims at a high level of generality and is described in the specification in an arbitrary form without disclosing a specific algorithm using available data for allowing the model to learn patterns and relationships within the data and implement it to perform the claimed function”. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements amount to more than mere instruction to apply the exception using generic computer component and have been re-evaluated under the “significantly more” analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claim 22 the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process along with Mathematical Concepts but for the recitation of generic computer components. For example, calculating a percental..., is/are Mathematical Concepts. The claims are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Subject Matter Free of Prior Art
Claims 1-2, 4-8, 10-14, 17, 19-20, and 22-23 have been found by the examiner to be free of prior art. A thorough search of the prior art was conducted and the examiner could not find a single reference or combination of references with adequate rationale to combine that would teach the claimed invention. Specifically, Examiner finds that none of the prior art teach or fairly suggests the limitation of “adapting at least one fetal biometric parameter depicting a historical gestational age of a sample fetus obtained by an ultrasonography device, to an adapted at least one fetal biometric parameter depicting a current gestational age at time of admission of a sample mother of the fetus to labor”, in combination with the other limitations of the claim.
Response to Amendment
Applicant's arguments filed 12/29/2025 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 8-16.
On page 10 of the remarks, the Applicant argues “Applicant contends that while the claim allegedly recites mental processes (e.g., diagnosing based on a threshold), it is not directed to an abstract idea alone, since it includes specific treatment steps which cannot be performed by a human mind, and do not fall into any of the aforementioned abstract ideas group: "in response to the likelihood being above a threshold indicating high likelihood of uCD, performing a cesarean delivery surgical procedure on the target mother”, Examiner respectfully disagrees. The claims, given their broadest reasonable interpretation, recite an abstract idea which have been analyzed under Step 2A, Prong One reciting a process for obtaining/collecting mother and fetus information to determine a likelihood of unplaced cesarean delivery (uCD) and provide instruction to perform the uCD, which are steps of observing, evaluating, judgment, and opinion that are citing a process for which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III), but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Mental Process.
Moreover, the step for performing a cesarean delivery surgical procedure on the target mother have been analyzed under Step 2A P2 as an post extra solution activity that does not affect the data generation for indicating the outcome of likelihood of uCD but rather describing using the outcome of the data computation using the mother and fetus data to recommend or refer for performing the procedure but no recitation or description in the speciation disclosing an actual process or steps of the mentioned procedure being performed other than based on the outcome analysis, instructing/directing to the performing cesarean or conventional vaginal delivery, see at least (Applicant PGPub [0020-0021]), and see Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012).
On page 9-11 of the remarks, the Applicant argues “Applicant submits that amended Claim 1 overcomes the 101 rejection in view of the recent decision from the United States Court of Appeals for the Federal Circuit (CAFC) in PowerBlock Holdings, Inc. v. iFit, Inc. dated August 11, 2025 (hereinafter "the PowerBlock case") ... Similarly, Applicant's claim recites a specific graphical user interface and specific hardware structure where a processor operatively connected to a display and to a network interface and/or data storage device accesses specific data, stores a specific trained machine learning model, and presents specific data (i.e., the outcome of the machine learning model fed the specific input data). ... Similarly, Applicant's claims are directed to a treatment method that specifically includes hardware components where the method as a whole, computes an indication of likelihood of uCD using a machine learning model trained in a specific way and performs surgery. Thus, Applicant reiterates that the claims recite enough specificity and structure to satisfy Alice step one.”, Examiner respectfully disagree. In PowerBlock Holdings the claim(s) is/are directed to adjusting dumbbells weights to provide the same weight on each dumbbell where the claim is limited to a particular type of dumbbell selector with a stack of nested left and right weight plates and a movable selector with different adjustment positions and using electric motor changes the number of left and right weight plates coupled to the dumbbell which was found “limited to a specific implementation of a technological improvement to” selectorized dumbbells and therefore it is directed to an eligible mechanical invention—an improved “machine,” i.e., “a concrete thing, consisting of parts, or of certain devices and combi nation of devices.” SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1332 (Fed. Cir. 2010); see 35 U.S.C. § 101. In contrast, the current application claim(s) is/are directed to predicting unplanned cesarean delivery (uCD) using mother and fetus data to generate an outcome indicating likelihood of uCD of a target mother.
In addition, the claim(s) of the current application dose/do not describe any technological improvement or technical field improvement other than computing components (i.e., processor, display, machine learning model, etc.) recited at a high level of generality and as tools to perform the steps of the identified judicial exception. As such, even when considering the claims additional elements, the claims as a whole, individually and in combination, provide no integration of the abstract ideas into a practical application that no meaningful limits on practicing the abstract idea are introduced, see MPEP 2106. The claims as a whole are therefore directed to an abstract idea. Therefore, the claim(s) of the current invention is/are not analogues to the claim(s) in PowerBlock.
On page 12-13 of the remarks, the Applicant argues “Applicant asserts that the claims are integrated into a practical application, since they recite specific treatment steps which integrate the alleged mental analysis steps into a practical application: "in response to the likelihood being above a threshold indicating high likelihood of uCD, performing a cesarean delivery surgical procedure on the target mother", and therefore eligible under step 2A ... Applicant submits that that amended claim 1 does not recite only the idea of a solution or outcome, but recites a solution to a problem, as discussed extensively in Applicant's specification. Moreover, the computer is used to improve the field of medicine, by reducing uCD, as discussed in Applicant's specification”, Examiner respectfully disagrees. As mentioned above, the claim(s), under BRI, recite steps for generating a likelihood of uCD while using generic computing components as tools to perform the claim steps, however the features listed in the claims, are not considered an improvement to another technology, or technical field, or an improvement to the functioning of the computer itself rather describes an improvement to analyzing and pregnant women data which is solving a health facility administrative and clinical issue, e.g., reducing uCD, using computers, for identify if a pregnant women is to be considered for cesarean or vaginal delivery. The fact that the judicial exception, identified in the rejection above, relies upon collecting user data, analyzing the data for parameters, does not impart an improvement to any existing computer, or any other technology or technical field. At best, this gathering of data to be used by substance injector device may improve the abstract idea of improving managing pregnant mothers’ delivery type. However, improving upon an abstract idea does not make the abstract idea any less abstract.
On page 13-14 of the remarks, the Applicant argues “Applicant respectfully disagrees, and contends that the Office Action has fundamentally mischaracterized the claimed surgical treatment feature. Amended independent claim 1 explicitly recites "in response to the likelihood being above a threshold indicating high likelihood of uCD, performing a cesarean delivery surgical procedure on the target mother" which is a specific, physical treatment step that transforms the alleged abstract analysis into a practical medical application” ... 1. ...Applicant submits that amended Claim 1 recites a particular treatment, i.e., Cesarean surgery. ... 2. ...Thus in the context of amended Claim 1, the step of performing a surgical procedure for cesarean delivery is significantly tied to a correlation between adapted at least one fetal biometric parameter of the target fetus and at least one personal parameter of the target mother and uCD, as computed by the machine learning model. ... 3. ... Applicant submits that similarly to the example discussed by the MPEP, the step of performing a cesarean delivery surgical procedure as recited in amended Claim 1 applies the exception, in that the information from the alleged mental analysis in the preceding steps of the Claim is used to determine whether the cesarean delivery surgical procedure is performed or not, Examiner respectfully disagrees. As mentioned in the above response to remarks, the claimed step argued by the Applicant of performing a cesarean delivery is rendered in the claim and the specification and described as suggestion or refereeing the delivery type based on the computed mother and fetus data, see Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012), and see the Applicant remarks in the argument in “3. ... the step of performing a cesarean delivery surgical procedure as recited in amended Claim 1 applies the exception, in that the information from the alleged mental analysis in the preceding steps of the Claim is used to determine whether the cesarean delivery surgical procedure is performed or not”.
Furthermore, in response to the Applicant remarks on page 14-15, “Applicant contends that the Office Action incorrectly characterizes the surgical treatment as "insignificant extra-solution activity" under MPEP § 2106.0S(g)”, Examiner disagrees to such argument. As discussed in the above rejection and responses, the claims are directed to analyzing a pregnant women and fetus data to generate and indication that determine a likelihood of uCD while the performing is of the delivery type is being analyzed as referring a user (e.g., healthcare provider, nurse, doctor, etc.) to perform a cesarean or vaginal based on the likelihood outcomes of the analysis which are well-known procedures for pregnant women delivery1 and as such has been analyzed as an insignificant extra-solution activity to the judicial exception, and as a nominal or tangential addition to the abstract idea and does not affect the generation of the data object (procedure parameter). In addition, Examiner points to Bukowski et al. (US 2024/0013925) and Shazly et al. (US 2023/0114033), disclosed on the PTO-892, as disclosing cesarean delivery assessment based on pregnancy data using machine learning as being well-known prior to the filing date of the instant application. The elements of the instant process, when taken alone, each execute in a manner conventionally expected of these elements. The elements of the instant process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Hence, these additional elements do not add anything significantly more than an abstract idea.
On page 15 of the remarks, the Applicant argues “The Office Action repeatedly indicates that a Cesarean procedure is conventional. Applicant cites the 2018 USPTO memo discussing the Vanda decision, treatment claims need not include non-routine/unconventional steps to be eligible under § 101. Thus, the assertion that the treatment step must be novel or unconventional in order to survive a § 101 rejection is misplaced – the novelty/unconventionality is an issue for§§ 102/103, not the§ 101 eligibility threshold in many treatment claim contexts”, Examiner disagrees to the Applicant argument. The Office Action indicted that a method for pregnant women delivery would be conducted either via vaginal or cesarean delivery which are conventional and standard methods for delivery, the Office Action has not asserted that the treatment steps must be novel needless to say that there is no recitation in the claim(s) or the specification indication any novel way of delivery other than analysis of a pregnant women and fetus data to generate an indication of type of deliver to be, for example, cesarean delivery. Furthermore, in the Vanda case, although the claims recited a law of nature for relationship between a patient genotype and the risk of QTc prolongation and treating a patient having schizophrenia with iloperidone, the court distinguished the claims based on the administration steps of the treatment administering iloperidone to the patient in a dose range that depends on the patient’s genotype to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. Accordingly, the court held Vanda’s claims eligible at the first part of the Alice/Mayo test (Step 2A) because the claims were not "directed to" the recited judicial exception, see Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). In contrast, as discussed above, the current application claim(s) is/are directed to analyzing a pregnant women and fetus data to generate an indication of type of deliver to be, for example, cesarean delivery. Therefore, the current applicant claim(s) is/are not analogues to the Vanda case.
Therefore, the Applicant argument(s) is/are not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Applicant's arguments with respect to the 35 U.S.C. § 103 rejection on page 16-20.
In response to the claim amendment and Applicant remarks, Examiner withdraws the 35 U.S.C. § 103 as indicated above in “Subject Matter Free of Prior Art” section.
Prior Art Cited but not Applied
The following document(s) were found relevant to the disclosure but not applied:
Lakra et al. “A prospective study of a new prediction model of vaginal birth after cesarean section at a tertiary care centre”.
Bisahnyui et al. “Comparative study of clinical methods versus ultrasound methods for accurate gestational age determination in different trimesters of pregnancy, Ndop District Hospital, North West region, Cameroon”.
The references are relevant since it discloses collecting mother and fetal data and determining a recommendation for delivery method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAAELDIN ELSHAER whose telephone number is (571)272-8284. The examiner can normally be reached M-Th 8:30-5:30.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
1 US 2023/0114033; US 2023/0090637