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 .
Response to Amendment
Applicant’s amendment dated August 7, 2026 is acknowledged. Currently claims 1-9 and 13-18 are pending in this application.
Response to Arguments
Applicant's arguments filed August 7, 2026 have been fully considered but they are not persuasive inasmuch as they apply to the amended rejections required by the amendments to the claims.
Applicant argues that the inclusion of “encoder models” to obtain inferred heart rate encodings cannot be done by the human mind and overcome the rejection under 35 U.S.C. 101. Examiner disagrees.
The definition of an “encoder” by Meriam Websters dictionary is “one that encodes” wherein encodes is “to convert (something, such as a body of information) from one system of communication into another especially : to convert (a message) into code.” Examiner asserts that, at a high level of simplicity, a doctor could take first and second heart rate segments and create a first and second inferred heart rate encodings based on the original signals. For example, the doctor could remove all portions of the segment that appeared to have large amounts of noise from movement of the mother, or they could average the heart rate across the segment to get an average heart rate, both of which could be considered “inferred heart rate data.”
More complicated encoder models are described in the specification, some of which cannot be reasonable performed in the mind. The claims as currently filed, however, do not include these specific encoder models and thus the amendments do not overcome the rejections under 35 U.S.C. 101, which have been amended and included below.
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 1-9, and 13-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of a non-transitory memory configured to store specific data and one or more processor adapted to access the memory and execute the instructions programmed to perform a method on that data without significantly more.
Step 1:
Claims 1-9 recite a system, and thus falls into a statutory category.
Claims 13-14 and 17-18 recite a computer implemented method and thus falls into a statutory category.
Claims 15-16 recite a non-transitory computer readable medium, and thus falls into a statutory category.
Step 2A, Prong 1
Claim 1 recites the following abstract idea:
a sensor interface for accessing a fetal heart rate signal of a fetus and a corresponding uterine activity signal;
a data interface for accessing model data representing a fetal heart rate prediction model configured to, based on a representation of a first fetal heart rate segment, a representation of a first uterine activity segment, and a representation of a second uterine activity segment, predict a representation of a second fetal heart rate segment;
a processor configured to:
obtain, via the sensor interface, a first fetal heart rate segment and a subsequent second fetal heart rate segment of the fetal heart rate signal;
obtain, via the sensor interface, a first uterine activity segment and a second uterine activity segment of the uterine activity signal, corresponding respectively to the first and second fetal heart rate segments;
apply a fetal heart rate encoder model to the first and second fetal heart rate segments to obtain first and second inferred fetal heart rate encodings representing the first and second fetal heart rate segments;
apply a uterine activity encoder model to the first and second uterine activity segments to obtain first and second inferred uterine activity encodings representing the first and second uterine activity segments;
apply a fetal heart rate prediction model to the first inferred fetal heart rate encoding, the first inferred uterine activity encoding, and the second inferred uterine activity encoding to obtain a predicted fetal heart rate encoding representing the second fetal heart rate segment; and
determine an anomaly score indicative of fetal health by comparing the predicted fetal heart rate encoding representing of the second fetal heart rate segment to the obtained second inferred fetal heart rate encoding, segment, and output the anomaly score.
All of these limitations, at the broadest reasonable interpretation, cover a method of organizing human activity and mental process except for the recitation of “a sensor interface” “a data interface” and “a processor subsystem”. See MPEP 2106.04(a)(2)II and III.
All of these steps, other than reciting that a sensor interface, a data interface, and a processor subsystem is performing these tasks, can be performed by a human.
Applying “encoder models” can be performed by a human. At the high level of simplicity, a doctor could take first and second heart rate segments and create a first and second inferred heart rate encodings based on the original signals. For example, the doctor could remove all portions of the segment that appeared to have large amounts of noise from movement of the mother, or they could average the heart rate across the segment to get an average heart rate, both of which could be considered “inferred heart rate data.” The doctor can then take that data, compare the measurements, and determine a simple anomaly score (e.g. 0 = no difference; 1 = difference).
Examiner notes that the claim does not require any limitations for collecting or generating the input data including the fetal heart rate and uterine activity, but merely only requires that the data be accessed.
As such, the claims are directed towards an abstract idea.
Step 2A, Prong 2
The claims do not include additional elements that integrate the abstract idea into a practical application. The following elements do not add meaningful limitation to the abstract idea.
The “sensor interface”, “data interface” and “processor subsystem” are recited at a high level of generality, i.e. as generic circuitry, performing a generic computer function of collecting and processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additionally limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification does not provide any indication that the computer processor is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer-implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, the generic computer functions merely are being used to implement an abstract idea is well-understood, routine, conventional activity.
For these reasons, there is no inventive concept in the claim and thus it is ineligible.
Dependent claims 2 and 7 further limit the abstract idea of the anomaly score.
Dependent claim 3 further limits the type of data obtained.
Dependent claim 4-6 and 9 further limit the abstract idea of processing the data segments.
Dependent claim 8 further includes a step of raising an alert if the anomaly score exceeds a threshold. An alert does not integrate the judicial exception into a practical application. A “alert” is generic post-solution activity. Therefore, this is not an example of applying or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. Instead, this "alert" step is an example of generally linking the use of a judicial exception to a particular field of use, which is an example of a limitation that the courts have found to not integrate a judicial exception into a practical application [MPEP 2106.04(d)(I) and 2106.05(h)].
Independent claim 13 includes all of the above abstract idea analysis in method claim form.
Independent claim 14 further includes training a fetal heart rate prediction model. This is also an abstract idea, as, at the broadest reasonable interpretation, all of these steps, other than reciting that a sensor interface, a data interface, and a processor subsystem is performing these tasks, can be performed by a human. For example, a human can take the previously determined a anomaly scores (e.g. 0 = no difference; 1 = difference) and predict what kind of data the next set will include. Examiner notes that the claim does not require any limitations for collecting or generating the input data including the fetal heart rate and uterine activity, but merely only requires that the data be accessed. As such, the claims are directed towards an abstract idea.
Independent claims 15-16 are computer readable medium forms of claims 13 and 14.
Dependent claim 17-18 further limit the abstract idea of processing the data segments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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