CTNF 17/822,269 CTNF 88094 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-42-04 AIA 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/8/26 has been entered. Response to Amendment Receipt is acknowledged of applicant's amendment filed on 3/9/26. Claims 4, 6, 16 and 18 are cancelled. Claims 1, 3, 8, 9, 13-15 and 20-26 are currently pending and an action on the merits is as follows. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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, 8, 9, 13-15 and 20-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of determining a baseline pulse rate, identifying a suspected transient decelerations, qualifying the suspected transient deceleration, removing the qualified transient deceleration from the sensed pulse rate signal to form a modified pulse rate signal, determining a modified HRV from the modified pulse rate signal. The limitations of determining a baseline pulse rate, identifying a suspected transient decelerations, qualifying the suspected transient deceleration, removing the qualified transient deceleration from the sensed pulse rate signal to form a modified pulse rate signal, determining a modified HRV from the modified pulse rate signal, as drafted, are processes that, under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processing circuitry”, and outputting digital data (all of which include or involve generic computer components), the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor and output language, “determining” “identifying” “qualifying” and “removing” in the context of this claim encompasses the user visually assessing a data stream or signal plot with minor calculations. 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. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim recites the processor and a visual display which are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. 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. The claim is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claims are not patent eligible. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 1, 3, 8-10, 13-15, 20-22 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moorman et al. US 2010/0234748 in view of Puertas et al. “Intrapartum fetal pulse oximetry and fetal heart rate decelerations” . Regarding claims 1, 13 and 20, Moorman discloses a device for detecting deterioration of a patient, the device comprising: a memory configured to store a sensed pulse rate signal indicative of one or more sensed pulse rates over time ([¶29] cardiac heart rate signals are collected and analyzed); and processing circuitry configured to: determine, from the sensed pulse rate signal, a baseline pulse rate ([¶67,77] comparisons are made to a baseline); identify a suspected transient deceleration, the suspected transient deceleration comprising a drop in the sensed pulse rate below the baseline pulse rate where the drop exceeds an amplitude threshold ([¶73,112,115] an amplitude threshold of 100ms is used) to within a range of a baseline pulse rate ([FIG. 3]); qualify the suspected deceleration from the sensed pulse rate signal to form modified pulse rate signal ([¶59] different features are compared or matched to determine if the deceleration is normal variation or a qualified deceleration); remove the qualified transient deceleration from the sensed pulse rate signal to form a modified pulse rate signal ([¶77]); store the modified pulse rate signal in the memory ([¶97,101] the determinations are stored in memory); determine a count of one or more qualified transient decelerations ([¶59,73]); determine a modified heart rate variability (HIRV) value from the modified pulse rate signal ([¶77] decelerations can be removed to have a better accuracy for the HRV); output, to a visual display, an alarm or notification indicative of the qualified transient deceleration or modified HRV value ([¶96] a display interface shows the determinations). Moorman does not disclose the processing circuitry is further configured to: determine a blood oxygen saturation (SpO2) value coinciding with each of the one or more transient decelerations, wherein the count is sortable according to the SpO2 value, and output information indicative of the sorted count or sorting the count or qualified event according to when the SpO2 value drops below a predetermined threshold, or according to an SpO2 value drop. Puertas teaches a similar monitoring system and method for determining fetal hypoxia that shows there is a known correlation between the oxygen saturation and the decelerations and that drops in saturation with decelerations are more indicative of hypoxia ([pg. 16, column 2]). Puertas teaches determine a count of one or more qualified transient decelerations ([pg. 13] A total of 787 decelerations were studied.” “Of the 787 decelerations analyzed (group A), 97 were classified as early (Al), 620 as variable (A2), 31 as late (A3) and 39 as prolonged (A4).) determine a SpO2 value coinciding with each of the one or more transient decelerations ([Table 4]). sorting the count or qualified event according to when the SpO2 value drops below a predetermined threshold, or according to an SpO2 value drop ([Table 1, Fig. 1] show the FSpO2 values at each time point for each of the four types of deceleration where basal (X-2) FSpO2 values were highest for early decelerations, followed by prolonged and variable decelerations, and were lowest for late decelerations. This result is evidence that different patterns of FHR are reflected as different degrees of fetal oxygenation). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to sort the qualified decelerations based on the associated oxygen saturations and combine those teachings from Puertas into Moorman in order to track hypoxia ([pg. 12]). Regarding claims 3 and 15, Moorman discloses the HRV value is a first HRV value and the determined HRV value is a first determined HRV value, wherein the processing circuitry is further configured to: determine a second HRV value based on the sensed pulse rate signal, wherein the second HRV value is at least partially based on the transient deceleration ([¶77] HRV can be determined without removing the decelerations); and output information indicative of the second determined HRV value ([¶96] a display interface shows the determinations). Regarding claims 7 and 19, Moorman discloses the count is sortable according to a period and amplitude of a sensed pulse rate of each of the one or more transient decelerations ([¶76-77] the amplitude and duration are used in classifying the decelerations). Regarding claim 8, Moorman discloses the processing circuitry is further configured to: determine that a sensed pulse rate of one or more sensed pulse rates associated with the transient deceleration falls below a predetermined key threshold; and based on the determination that the sensed pulse rate of the transient deceleration falls below the predetermined key threshold ([¶73,77] different thresholds are used for significant decelerations from normal accelerations and decelerations), output information indicative of the transient deceleration being a key transient deceleration ([¶96] a display interface shows the determinations). Regarding claim 9, Moorman discloses the processing circuitry is further configured to: determine a deceleration skew associated with the transient deceleration ([¶21,74] asymmetry is determined which is the same as skewness); and output information indicative of the deceleration skew ([¶96] a display interface shows the determinations). Regarding claim 10, Moorman discloses the processing circuitry is further configured to: determine one or more accelerations in the sensed pulse rate signal ([¶30,73] accelerations can be determined); determine at least one acceleration skew associated with at least one of the one or more accelerations ([¶21,74] asymmetry is determined which is the same as skewness); and output information indicative of the at least one acceleration skew ([¶96] a display interface shows the determinations). Regarding claim 21, Moorman discloses the processor being configured to qualify the suspected transient deceleration as a qualified transient deceleration comprises being configured to check for symmetry in the suspected transient deceleration ([¶67,74] asymmetry is determined). Regarding claim 22, Moorman discloses the processor being configured to qualify the suspected transient deceleration as a qualified transient deceleration comprises being configured to compare the suspected transient deceleration to a template ([¶4] template functions can be used). Regarding claim 24, Moorman discloses the processor being configured to identify the suspected transient deceleration comprises being configured to identify that the return of the sensed pulse rate to within the range of the baseline pulse rate takes place within a time period ([¶63-72]). Regarding claim 25, Moorman discloses wherein determining the transient deceleration comprises identifying a suspected transient deceleration and qualifying the suspected transient deceleration as a qualified transient deceleration based on a model, a template, or a symmetry check ([¶67,74] asymmetry is determined. [¶4] template functions can be used). Regarding claim 26, Moorman discloses determining clinical risk but does not disclose initiating an alarm based on the determined transient deceleration. Baker discloses a similar heart rate monitoring system that display alarms ([¶76]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Moorman with the teachings of Baker in order to better determine or predict disease ([¶104]) . 07-21-aia AIA Claim (s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moorman in view of Puertas further in view of Hamilton et al. US 2004/0133115 . Regarding claim 23, Moorman does not specifically disclose the device comprising a neural network or machine learning model trained to qualify the suspected transient deceleration as the qualified transient deceleration. Hamilton teaches a similar heart rate monitoring system that uses machine learning ([¶178,239]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Moorman with teachings of Hamilton in order to classify events not seen in the training population ([¶178]) . Response to Arguments 07-37 AIA Applicant's arguments filed 3/9/26 have been fully considered but they are not persuasive. Regarding Applicant’s arguments against the 101 rejection, Examiner respectfully disagrees. Regarding step 2A prong two, the claims do not recite a practical application as the recited additional components merely link the abstract idea to a particular technical environment but not a practical application. Similarly, in the step 2B analysis there is no clear improvement to the technology. Applicant states that associating the SpO2 with the deceleration may indicate more clinically relevant decelerations but the claims and the specification are not clear if this actual is providing an improvement. Associating the two data may not provide any insight or clarification. Applicant’s specification at ¶90 just states the count can be sorted based on the SpO2 value but does not disclose that this provides any improvement or advantage. Applicant’s arguments with respect to the 35 USC 102 and 103 rejections have been considered but are moot because the new ground of rejection rely on a different combination of references. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791 Application/Control Number: 17/822,269 Page 2 Art Unit: 3791 Application/Control Number: 17/822,269 Page 3 Art Unit: 3791 Application/Control Number: 17/822,269 Page 4 Art Unit: 3791 Application/Control Number: 17/822,269 Page 5 Art Unit: 3791 Application/Control Number: 17/822,269 Page 6 Art Unit: 3791 Application/Control Number: 17/822,269 Page 7 Art Unit: 3791 Application/Control Number: 17/822,269 Page 8 Art Unit: 3791 Application/Control Number: 17/822,269 Page 9 Art Unit: 3791 Application/Control Number: 17/822,269 Page 10 Art Unit: 3791
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