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 .
Applicant's response filed 12/9/2025 has been fully considered. The following rejections
and/or objections are either reiterated or newly applied.
Status of Claims
Claims 20-27 newly added.
Claims 2, 6, 12, and 16-19 canceled.
Claims 1, 3-5, 7-11, 13-15, and 20-27 pending and examined on the merits.
Priority
The instant application is a 371 national stage entry of PCT/EP2020/074094 filed on 8/28/2020, and claims the benefit of foreign priority to Application No. 19194299.4 filed on 8/29/2019. Thus, the effective filing date of the claims is 8/29/2019.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Claim Objections
The objections to claim 7 withdrawn in view of Applicant's claim amendments filed 12/9/2025.
Claim Interpretation
35 USC § 112(f)
Examiner is persuaded by Applicant's arguments; therefore, the claims are no longer interpreted as invoking 35 USC 112(f), and are given their broadest reasonable interpretation without being limited to the specific embodiments in the specification.
Withdrawn Rejections
35 USC § 112(b)
The rejection of claims 8 and 14-15 under 35 U.S.C. 112(b) as being indefinite due to unclear claim language withdrawn in view of Applicant's claim amendments filed on 12/9/2025. However, these claims are still rejected under 35 U.S.C. 112(b) for referencing a figure or depending from a claim which references a figure.
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 1, 3-5, 7-11, 13-15, and 20-27 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.
Regarding claims 1, 3-5, 7-11, 13-15, and 20-27, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Listed below are the references to figure identifiers in Figure 1 in the amended claims filed 12/9/2025 (if not listed below, the claim is rejected due to dependency on rejected independent claim 1 or 10):
Claim 1 line 3 "said pregnant woman (1)", the identifier "(1)"
Claim 3 line 4 "the pregnant woman (1)", the identifier "(1)"
Claim 10 lines 1-4 "An electronic system for predicting the delivery time of a pregnant woman (1), comprising: a wearable device (4, 5, 6) configured to be worn outside of the pregnant woman's body; at least one sensor (2, 3, 4)"
Claims 11 lines 2-3 "the wearable device (4, 5, 6) comprising comprises a bracelet (5), wherein said at least one sensor (2, 3, 4) is arranged in said wearable device (4, 5, 6), and wherein said at least one sensor (2, 3, 4)"
Claim 13 lines 1-2 "an input field (10)"
Claim 14 lines 1-5 "The electronic system according to claim 10, wherein said at least one sensor (2, 3, 4) is connectable to a server (9) by way of a communication unit which is configured to transmit data corresponding to at least some of said at least [[two]] one variable body parameter[[s]] detected by said at least one sensor to said server (9) and to obtain from said server (9) the result of said pattern recognition regarding said transmitted data"
Claim 15 lines 3-5 "a server (9) configured to compare data corresponding to said at least one variable body parameter detected by the client with patterns and correlations stored on said server (9)"
Claim 21 line 2 "said pregnant woman (1)"
Claim 24 line 1 "the at least one sensor (2, 3, 4)"
Claim 25 lines 1-3 "the wearable device (5) comprises at least one further sensor (2, 3, 4) which is arranged in said wearable device (5), wherein said at least one further sensor (2, 3, 4) is a heart rate sensor"
Response to Arguments under 35 USC § 112
Applicant’s arguments filed 12/9/2025 are fully considered but they are not persuasive.
Applicant asserts that claims 1, 3, 8, and 10-17 do "not incorporate a figure or a table by reference" (Remarks 12/9/2025 Page 1). Examiner notes the references to figure identifiers in the amended claims filed 12/9/2025 (as the identifiers are still present in these amended claims) as indicated in the above section "Claim Rejections - 35 USC 112" subsection 112(b).
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, 3-5, 7-11, 13-15, and 20-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1 and 10: “carrying out a pattern recognition by a calculation unit” provides a mathematical calculations (performing pattern recognition by a calculation unit) that is considered a mathematical concept, which is an abstract idea.
“calculating a predicted delivery time or delivery period by the calculation unit based on said pattern recognition” provides a mathematical calculations (calculating a delivery time or period by the calculation unit) that is considered a mathematical concept, which is an abstract idea.
Claim 7: “selecting a body parameter or parameters for detection in dependence on a time remaining until the predicted delivery time or delivery period” provides an evaluation (determining which parameters to measure based on time remaining until predicted delivery) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 8: “evaluating a plurality of data sets of detected body parameters in their development over time towards the actual delivery time for recognizing patterns” provides an evaluation (evaluating data for patterns) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 21: “carrying out pattern recognition with regard to the development of said at least two body parameters over time by the calculation unit” provides an evaluation (pattern recognition involves identifying trends or structures in data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 22: “the pattern recognition detects whether the body temperature in a morning measurement is lower than in a previous evening measurement” provides an evaluation (pattern recognition involves identifying trends or structures in data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
All other claims depend from claims 1 and 10, therefore are directed to an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claims 10-15 recite performing some aspects of the analysis on “An electronic system” (above interpreted as “A non-transitory computer-readable medium”), there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-19 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claims 1 and 10: “detecting at least two body parameters of said pregnant woman at multiple points in time” provides insignificant extra-solution activities (detecting or measuring parameters is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 4: “detecting a manual input of an additionally determined body parameter” provides insignificant extra-solution activities (detecting or measuring parameters is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 6: “displaying the predicted delivery time or delivery period with a display at least three days prior to the predicted delivery time” provides insignificant extra-solution activities (displaying outputs) that do not serve to integrate the judicial exceptions into a practical application.
Claim 8: “detecting an actual delivery time in an automated manner or by manual input” provides insignificant extra-solution activities (detecting or measuring parameters is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“storing said patterns, and providing said patterns for pattern recognition” provides insignificant extra-solution activities (storing data is a post-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 9: “storing specific parameters relating to said pregnant woman or her environment, and weighting of said pattern recognition in dependence of said specific parameters” provides insignificant extra-solution activities (storing data and applying weights [or optimizing] are post-solution activities involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 14: “transmit data corresponding to at least some of said at least two variable body parameters detected by said at least one sensor to said server and to obtain from said server the result of said pattern recognition regarding said transmitted data” provides insignificant extra-solution activities (transmitting and receiving data are post-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 15: “to use said comparison to calculate the predicted delivery time or delivery period” and the interpretation (see section 112(b)) "running the trained pattern recognition model using the incoming data" provides insignificant extra-solution activities (executing a model is a pre-solution activity involving data gathering and manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 22: “measuring the body temperature of the pregnant woman at least two times a day, wherein the at least two times a day are in the morning and in the evening” provides insignificant extra-solution activities (taking measurements is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
The steps for detecting, measuring, transmitting, receiving, storing, and displaying data, and optimizing and running models are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data gathering and manipulation steps (see MPEP 2106.04(d)(2)). Furthermore, the limitations regarding implementing program instructions do not indicate that they require anything other than mere instructions to implement the abstract idea in a generic way or in a generic computing environment. As such, this limitation equates to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Therefore, claims 1-19 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional elements to indicate that the claimed “electronic system” (interpreted here as “A non-transitory computer-readable medium”) requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for detecting, measuring, transmitting, receiving, storing, and displaying data, and optimizing and running models are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are well-understood, routine, and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-19 are not patent eligible.
Response to Arguments under 35 USC § 101
Applicant’s arguments filed 12/9/2025 are fully considered but they are not persuasive.
Applicant asserts that claims 1 and 10 are patent-eligible under 35 USC 101 because "they are directed to a specific technological solution for predicting the delivery time of a pregnant woman using a wearable device and physiological data - not to an abstract idea" (Remarks 12/9/2025 Page 2). Applicant further asserts that the additional elements "are integrated into a practical application: a non-invasive, sensor-based system that improves prediction accuracy and comfort for pregnant users" (Remarks 12/9/2025 Page 2), and that the "claims also recite inventive concepts that go beyond conventional steps [] in claims 22 and 26, the detection of a circadian rhythm change" (Remarks 12/9/2025 Page 3). In summary, Applicant argues "the claims are directed to a statutory process and system, are integrated into a practical application, and contain inventive concepts that transform any abstract idea into a patent-eligible invention" (Remarks 12/9/2025 Page 3). Examiner notes that while there are wearable devices involved in the claim limitations, they are merely additional elements used for data gathering. Additionally, the circadian rhythm detection provides a mental process of pattern recognition which is an abstract idea, and the temperature measurements are also merely additional elements that are well-understood, routine, and conventional. Together, these are indeed insignificant extra-solution activities that does not serve to integrate the recited judicial exceptions into a practical application, as detailed above in section "Claim Rejections - 35 USC 101".
The Examiner also notes that MPEP 2106(I) states that if the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). In the “search for an ‘inventive concept’” (the second part of the Alice/Mayo test), the additional elements identified do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception because taking temperature measurements are all well-understood, routine, and conventional techniques that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Therefore, combining insignificant extra-solution activities with any of the identified judicial exceptions would not result in patent eligible subject matter because integrating well-understood, routine, and conventional techniques does not yield “significantly more” to a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon.
Therefore, the rejection of claims 1 and 10 under 35 USC 101 is maintained. All other claims depend from these independent claims; therefore, their rejection is likewise maintained.
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.
Claims 1, 3-5, and 7 rejected under 35 U.S.C. 103 as being unpatentable over Boniface et al. (US-20190234954) in view of Ziarno et al. (US-20110190579) and Constantin et al. (US-20190252079).
Regarding claim 1, Boniface teaches a method for predicting the delivery time of a pregnant woman (Para.0073 "The present disclosure is further specifically based, in part, on the unexpected discovery that pairs of biomarkers disclosed herein can be utilized in methods of estimating the due date of a pregnant female, subsequently referred to as the Estimated Due Date (EDD) and/or estimating time to birth (TTB).").
Boniface also teaches detecting at least two body parameters of said pregnant woman at multiple points in time, carrying out a pattern recognition by a calculation unit with regard to the development of said at least two body parameters over time, calculating a predicted delivery time or delivery period by the calculation unit based on said pattern recognition:
Two body parameters and correlating them: Para.0199 "In some embodiments, each of the proteins, peptides and clinical variables disclosed herein as components of pairs, ratios and/or reversal pairs can serve as clock proteins to normalize component peptides in signatures to improve predictive performance or to select appropriate biomarkers and/or classifiers. Accordingly, the present invention comprises methods for estimating gestational age (GABD) comprising measuring one or more clock proteins and correlating said measurement to GABD [gestational age at blood draw]."
At multiple points in time: Figure 1 and Para.0070 "Kinetic plot of the protein ratio of CATD/TENX over the a Gestational Age at Blood Draw (GABD) window of 140 to 153 shows an AUC of 82% in separating those subjects that gave birth significantly earlier (i.e. before 270 days) than the population average of 280 days" imply that measurements are being taken at multiple points in time.
Carrying out pattern recognition (modeling): Para.0095 "Additional clinical variables useful for as markers can be identified using learning algorithms known in the art, such as linear discriminant analysis, support vector machine classification, recursive feature elimination, prediction analysis of microarray, logistic regression, CART, FlexTree, LART, random forest, MART, and/or survival analysis regression, which are known to those of skill in the art and are further described herein."
Boniface also teaches at least one of said at least two body parameters is a substance concentration in a body fluid of said pregnant woman (Para.0192 "For a biomarker, such a measurable feature can include, for example, the presence, absence, or concentration of the biomarker, or a fragment thereof, in the biological sample").
Boniface does not explicitly teach at least another of said at least two body parameters is a vital parameter, or using a wearable device worn outside of the pregnant woman's body.
However, Ziarno teaches at least another of said at least two body parameters is a vital parameter (Para.0205 "For example, the data capture system may provide information about the heart rate of a user, an infrared system within the data capture system may provide the change in volume of blood flow, a heart rate detector of a fetus inside the womb of the user may provide the information about an expectant mother and a fetus within a womb").
However, Constantin teaches using a wearable device worn outside of the pregnant woman's body (Para.0050 "Examples 1-40 may be configured such that the first real-time datum is measured, received, or determined by an external device" and para.0504 "Of course, such an algorithm and data may also be used on its own to assist pregnancy efforts or if using the rhythm method for birth control").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Boniface as taught by Ziarno in order to provide contraction information to the predictive model (para.0205 "The intravaginal monitoring device may consist of a data capture system for providing contraction information (by way of example in a graph, e.g. contraction intensity and periodicity) using a contraction system, the contraction system may use multiple mechanisms for determining useful information associated with the contractions"). One skilled in the art would have a reasonable expectation of success because both approaches are utilizing body parameter data in artificial intelligence/machine learning models for time to birth prediction.
Therefore, while Constantin is focused on glucose monitoring and delivery, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Boniface as taught by Constantin in order to gather additional datapoints in a non-invasive manner (para.0325 "For example, the sensor 106 may be a [], non-invasive, [] sensor, as described above. In some examples, the sensor may be a wearable or implantable sensor that is connected to the patient" and para.0573 "the continuous analyte sensor 10 comprises a sensor for detecting and/or measuring analytes, and the continuous analyte sensor 10 may be configured to continuously detect and/or measure analytes as a non-invasive device"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with measuring various biomarkers using a wearable device in order to generate predictions about the state of the user or patient.
Regarding claims 3 and 4, Boniface in view of Ziarno teach the methods of Claim 1 on which this claim depends/these claims depend, respectively. Ziarno also teaches: the vital parameter is a heart rate, a blood flow, a body temperature, a breathing frequency, an electrical resistance of the skin, and/or a blood pressure, of the pregnant woman; and detecting a manual input of an additionally determined body parameter, wherein the additionally determined body parameter is a contraction frequency and/or at least one parameter from a cardiotocography, and wherein calculating a predicted delivery time or delivery period includes taking into account said additionally determined body parameter (Para.0205 "The intravaginal monitoring device may consist of a data capture system for providing contraction information (by way of example in a graph, e.g. contraction intensity and periodicity) using a contraction system, the contraction system may use multiple mechanisms for determining useful information associated with the contractions. For example, the data capture system may provide information about the heart rate of a user, an infrared system within the data capture system may provide the change in volume of blood flow, a heart rate detector of a fetus inside the womb of the user may provide the information about an expectant mother and a fetus within a womb").
Regarding claim 5, Boniface in view of Ziarno teach the methods of Claim 1 on which this claim depends/these claims depend. Boniface also teaches said pattern recognition comprises a recognition of correlations in the developments of the at least two body parameters (Para.0199 "Accordingly, the present invention comprises methods for estimating gestational age (GABD) comprising measuring one or more clock proteins and correlating said measurement to GABD [gestational age at blood draw].").
Regarding claim 7, Boniface in view of Ziarno teach the methods of Claim 1 on which this claim depends/these claims depend. Boniface also teaches selecting a body parameter or parameters for detection is dependent on a time remaining until the predicted delivery time or delivery period (Para.0078 "The invention lies, in part, in the selection of particular biomarkers that, when paired together, can accurately determine the EDD and/or TTB based on pairs of biomarkers. Accordingly, it is human ingenuity in selecting the specific biomarkers that are informative upon being paired, for example, in novel reversals that underlies the present invention", and Para.0109 "The term “clock protein” as used herein, refers to biomarkers that provide information on the due date of a pregnant subject, the state of development and/or age of a fetus or the progress through pregnancy. There are a number of important ways that these biomarkers can be advantageously used in assessing development including, for example, (1) for the prediction of gestational age at birth or time to birth (TTB) from the moment the blood is drawn to deliver and (2) for prediction of the gestational age at the time blood is drawn. In addition, clock proteins can serve to normalize component peptides in signatures to improve predictive performance or to select appropriate biomarkers and/or classifiers.").
Regarding claims 20 and 21, Boniface in view of Ziarno and Constantin teach the method of Claim 1 on which this claim depends/these claims depend. Ziarno also teaches detecting at least two vital parameters comprising a heart rate and a body temperature (Figure 22 and Para.0059 "The sensors include, by way of further example, temperature sensors, pressure sensors, glucose sensing, PH sensing, EKG, microbe sensors, DNA sensors, RNA sensors, protein sensors, drug sensors and an optional sonogram.", and Para.0205 "For example, the data capture system may provide information about the heart rate of a user, an infrared system within the data capture system may provide the change in volume of blood flow, a heart rate detector of a fetus inside the womb of the user may provide the information about an expectant mother and a fetus within a womb").
Regarding claims 22 and 23, Boniface in view of Ziarno and Constantin teach the method of Claim 1 on which this claim depends/these claims depend. Constantin also teaches taking multiple measurements over various time periods for period insights and retrospective summaries (Para.0350 "For example, a periodic insight may include a retrospective summary at the end of a period of time such as a day, week, month, or quarter, a post-workout summary, a summary after a period of time (e.g. number of hours, or morning or afternoon or night), or variants thereof" and variations of calculation times is obvious because it is a design choice because there is no technical improvement shown).
Claims 8-11 and 13-15 rejected under 35 U.S.C. 103 as being unpatentable over Boniface et al. (US-20190234954) in view of Ziarno et al. (US-20110190579) and Constantin et al. (US-20190252079) as applied to claims 1, 3-5, and 7 above, and further in view of Pengetnze et al. (US-20190122770).
Boniface et al. in view of Ziarno et al. and Constantin et al. are applied to claims 1, 3-5, and 7.
Regarding claim 8, Boniface in view of Ziarno and Constantin teach the method of Claim 1 on which this claim depends/these claims depend.
Boniface nor Ziarno explicitly teaches detecting an actual delivery time in an automated manner or by manual input, and evaluating a plurality of data sets of detected body parameters in their development over time towards the actual delivery time for recognizing patterns, storing said patterns, and providing said patterns for pattern recognition (i.e. retraining the model).
However, Pengetnze teaches tuning an AI model using actual observed outcome data and separately analyzing the variables for contributions to the incorrect outcome (Para.0021 "The artificial intelligence model tuning process may compare the actual observed outcome of the event to the predicted outcome then separately analyze the variables within the model that contributed to the incorrect outcome.").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Boniface and Ziarno as taught by Pengetnze in order to improve the accuracy of the model (Para.0021 "The artificial intelligence model tuning process may periodically retrain the predictive model algorithm for improved accurate outcome to allow for selection of the most accurate statistical methodology, variable count, variable selection, interaction terms, weights, and intercept"). One skilled in the art would have a reasonable expectation of success because both approaches are utilizing artificial intelligence/machine learning for prediction of delivery time.
Regarding claim 9, Boniface in view of Ziarno and Constantin teach the method of Claim 1 on which this claim depends/these claims depend. Pengetnze also teaches storing specific parameters relating to said pregnant woman or her environment, and weighting of said pattern recognition in dependence of said specific parameters (Abstract "a predictive model including a plurality of weighted risk variables and risk thresholds, a risk logic module configured to identify a pool of pregnant patients and to apply the predictive model to the patient data of the pool of pregnant patients to determine a risk score for each pregnant patient to identify at least one patient who is at risk for preterm birth").
Regarding claims 10 and 14-15, Boniface in view of Ziarno and Constantin teach the method of Claim 1 on which this claim derives its computer implemented method. Pengetnze also teaches the computer system, server, and client-server system on which claim 1 might be implemented (Para.0012 " It should be noted that the computer system may comprise one or more local or remote computer servers operable to transmit data and communicate via wired and wireless communication links and computer networks. The system also includes one or more database that is used to store the patient data." and "The system also includes interfaces [] that permit authorized access by the healthcare team and the patient respectively via a variety of computing devices (e.g., mobile devices, tablet computers, laptop computers, desktop computers, servers, etc.). The data may be presented and displayed to the healthcare team/patient in the form of web pages, web-based message, text files, video messages, multimedia messages, text messages, e-mail messages, mobile applications, and in a variety of suitable formats.").
Regarding claims 11, Boniface in view of Ziarno, Constantin, and Pengetnze teach the method of Claim 10 on which this claim depends/these claims depend. Ziarno also teaches the biosensors of claims 2 and 3 for protein and vital parameter measurements, respectively (Figure 22 and Para.0059 "The sensors include, by way of further example, temperature sensors, pressure sensors, glucose sensing, PH sensing, EKG, microbe sensors, DNA sensors, RNA sensors, protein sensors, drug sensors and an optional sonogram.").
Regarding claim 13, Boniface in view of Ziarno, Constantin, and Pengetnze teach the method of Claim 10 on which this claim depends/these claims depend. Boniface also teaches the input field for claim 4’s manual input of additionally determined body parameters (Para.0251 "The data are then input into a predictive model, which will classify the sample according to the state. The resulting information can be communicated to a patient or health care provider.").
Regarding claims 24 and 25, Boniface in view of Ziarno, Constantin, and Pengetnze teach the method of Claim 10 on which this claim depends/these claims depend. Ziarno also teaches detecting at least two vital parameters comprising a heart rate and a body temperature (Figure 22 and Para.0059 "The sensors include, by way of further example, temperature sensors, pressure sensors, glucose sensing, PH sensing, EKG, microbe sensors, DNA sensors, RNA sensors, protein sensors, drug sensors and an optional sonogram.", and Para.0205 "For example, the data capture system may provide information about the heart rate of a user, an infrared system within the data capture system may provide the change in volume of blood flow, a heart rate detector of a fetus inside the womb of the user may provide the information about an expectant mother and a fetus within a womb").
Regarding claims 26 and 27, Boniface in view of Ziarno, Constantin, and Pengetnze teach the method of Claim 10 on which this claim depends/these claims depend. Constantin also teaches taking multiple measurements over various time periods for period insights and retrospective summaries (Para.0350 "For example, a periodic insight may include a retrospective summary at the end of a period of time such as a day, week, month, or quarter, a post-workout summary, a summary after a period of time (e.g. number of hours, or morning or afternoon or night), or variants thereof" and variations of calculation times is obvious because it is a design choice because there is no technical improvement shown).
Response to Arguments under 35 USC § 103
Applicant’s arguments filed 12/9/2025 are fully considered but they are not persuasive.
Applicant argues that "[n]either Boniface nor Ziarno, alone or in combination, disclose or suggest at least detecting at least one body parameter of said pregnant woman at multiple points in time using a wearable device worn outside of the pregnant woman's body" (Remarks 12/9/2025 Pages 3-4). Examiner agrees, however, the amendments required new grounds for rejection further in view of Constantin et al. as described in the above section "Claim Rejections - 35 USC 103".
Applicant asserts that "Ziarno does disclose a device for monitoring pregnant women, but it is fundamentally different" (Remarks 12/9/2025 Page 4). Examiner also agrees and submits that Constantin does in fact teach an externally worn device. Additionally, Applicant concedes that Ziarno does in fact rememdy the alleged sensor deficiencies of Boniface, however it is invasive. Again, Examiner points Applicant to the new grounds for rejection under 35 USC 103 in view of Constantin et al.
Applicant argues that because Pengetnze is directed to analyzing insurance claims data, that it would not be suitable for "real-time physiological sensor readings" (Remarks 12/9/2025 Page 5). Examiner notes that in In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958), the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplish the same result is not sufficient to distinguish over the prior art (see also Manual of Patent Examining Procedure, U.S. Trademark and Patent Office, section 2144.04, III). In the instant case, claim 10 merely makes the process of Boniface et al., Ziarno et al., and Constantin et al. as computer-implemented or automatic and indeed accomplishes the same result. It is thus not sufficient to distinguish over the referenced art. Therefore, the claimed invention, i.e. the electronic system for predicting the delivery time of a pregnant woman would have been obvious to a person of ordinary skill in the art at the time the invention was made over the process disclosed by Boniface et al., Ziarno et al., and Constantin et al. One of ordinary skill in the art would have been motivated to make it completely automatic by comprising instructions in the computer readable medium for executing all steps of the method to take the obvious advantage of a fully automatic process, i.e. saving time and cost. There would have been a reasonable expectation of success because the court held regarding software that “writing code for such software is within the skill of the art, not requiring undue experimentation, once its functions have been disclosed.” Fonar Corp., 107 F.3d at 1549, 41 USPQ2d at 1805. Therefore, the resource requirements for analyzing "real-time physiological sensor readings" involve no improvement to technology and are themselves well-understood, routine, and conventional.
Applicant argues that new claims 20, 21, 24, and 25 are not taught by Ziarno even though temperature and heart rate sensors are disclosed, "Ziarno does not teach that pattern recognition of body temperature (or temperature combined with heart rate) over time is used to predict the date/time of birth" (Remarks 12/9/2025 page 6). Ziarno, while directed towards an internal wearable device, does disclose predicting delivery time using sensor data. The sensor data encompasses both heart rate and temperature, therefore Ziarno does in fact teach these new limitations as described above in section "Claim Rejections - 35 USC 103" but recited here for convenience (Abstract "The intravaginal monitoring device and or network includes multiple modes of operation that enable [], pre-birth monitoring and prediction", Para.0233 "The intravaginal monitoring device's and system's mode of operation may include labor and delivery patient management", Para.0205 "For example, the data capture system may provide information about the heart rate of a user", and Figure 22 and Para.0059 "The sensors include, by way of further example, temperature sensors").
Applicant argues that new claims 22, 23, 26, and 27 are not disclsoed by Boniface, Ziarno, or Pengetnze (Remarks 12/9/2025 Page 6). Examiner agrees, however, the amendments required new grounds for rejection further in view of Constantin et al. as described in the above section "Claim Rejections - 35 USC 103".
Therefore, the rejection of claims 1 and 10 under 35 USC 103 is maintained, and the new grounds for rejection of claims 20-27 under 35 USC 103 are newly made. All other claims depend from these independent claims; therefore, their rejection is likewise maintained.
Conclusion
No claims are allowed.
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 TH REE-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 finaI action.
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/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686