DETAILED ACTION
Claims 1-15 are pending in the present application. Claims 1, 6, and 11 were amended in the response filed 16 July 2026.
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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tonnsen et al. Heart Rate-Defined Sustained Attention in Infants at Risk for Autism in view of Martien et al. US Patent Application Publication No. 2019/0209097.
Regarding claim 1, Tonnsen et al. teaches the following:
A system for predicting risk of diagnosis of Autism Spectrum Disorder (ASD) for an infant , of a predetermined postmenstrual age (PMA), based on neonatal analytics sourced from one or more Neonatal Intensive Care Unit (NICU) records for said infant, [note: Abstract, autism and heart rate in infants, figures 1 and 2] comprising:
a processor [note: page 6, Autism diagnostic symptoms through analytic plan; figure 2 ];
a processor-readable memory including processor-executable instructions for [page 6], figure 2]:
calculating gestational age (GA) of said infant:
receiving and storing heart rate (HR) pattern data compiled from neonatal monitoring of said infant of said (PMA) for a predetermined time period [note: page 3, heart rate “infants at risk for ASD”, pilot study of 9- to 18-months; page 5, increasing faster heart rate predicts ASD risk];
evaluating one or more parameters derived from said HR pattern data to assess a behavior of said one or more parameters within said predetermined time period [note: page 3, heart rate “infants at risk for ASD”, pilot study of 9- to 18-months; page 5, increasing faster heart rate predicts ASD risk];
determining whether the behavior of any of said one or more parameters increases or decreases in magnitude, relative to a datum, during one or more portions of time of said predetermined time period that extend from a conclusion of said calculating of said GA and comprise a portion of a chronological age of said infant according to said NICA records [note: page 3, heart rate “infants at risk for ASD”, pilot study of 9- to 18-months; page 5, increasing faster heart rate predicts ASD risk].; and
in response to a determination of increasing behavior, determining that said risk is positive [note: page 3, heart rate “infants at risk for ASD”, pilot study of 9- to 18-months; page 5, increasing faster heart rate predicts ASD risk]..
Although Tonnsen et al. teach the invention substantially as cited above, they do not explicitly teach calculating a gestational age of said infant. They do discuss gestational age of infants [note: page 3, heart rate “infants at risk of ASD”, pilot study 9 to 18 months]. However Martin et al., further details calculation of a gestational age of an infant [note: paragraph 0052, “the processor 104 may perform a statistical analysis to produce a statistical prediction or compute a likelihood quantifying a risk of the patient” (processor calculates or computes analysis as part of the monitoring system); paragraph 0073, “data collection in HRA infants included: Gestational Age (GA) at birth, Post Menstrual AGE (PMA), Chronological Age”, also se paragraph 0039 “detecting within the first year of life, and as early as the neonatal period, within approximately a month of birth”]. It would have been obvious to one of ordinary skill at the time of the effective filing date to have combined the cited references since they are both directed toward detecting autism in infants. Further, Martin et al. details various age categories, and sensors such as a cardiovascular sensor, (i.e. for heart rate) may be implemented [see: paragraphs 039 and 0046]. .
Claim 2: The system according to claim 1, wherein: said predetermined time period comprises said one or more portions of time within a PMA of 34-42 weeks of said infant [note: page 3, infants; figures 2 through 3 ].
Claim 3: The system according to claim 2, wherein: said one or more parameters comprise a measured HR standard deviation and a measured HR skewness (HRskw) each calculated for about ten (10) minute segments of HR pattern data and averaged on at least an hourly basis for each of said one or more portions of time within said PMA of 34-42 weeks of said infant [note: page 3, infants; figures 2 through 3 ].
Claim 4: The system according to claim 3, wherein: said datum corresponds to any one of (a) a predetermined, respective HR standard deviation or HRskw value and (b) a respective HR standard deviation or HRskw value for a preceding one of said one or more portions of time, within said PMA of 34-42 weeks, of equal duration [note figures 1-3 ].
Claim 5: The system according to claim 4, wherein: an increase in the measured HRskw value is based on one or more accelerations in said HR pattern data [note: page 5, increase in heart rate predicts ASD in infants ].
The limitations of claims 6-15 parallel claims 1-5, therefore they are rejected under the same rationale.
Response to Arguments
Applicant's arguments filed 16 July 2026 have been fully considered but they are not persuasive.
ARGUMENT: Claims 1-15 were rejected under 35 USC 112 first paragraph for written description of the limitation calculating. Applicant’s state table 1 in the disclosure depicts a table wherein data results are depicted. Data was derived and depicted in table..
RESPONSE: The rejection has been withdrawn.
ARGUMENT: The prior art Tonnsen et al. focuses on individuals progressing throughout solely on a chronological age not contemplated by Applicant’s embodiment. Neonatal monitoring is not disclosed, and does not teach the amended feature of calculating (i.e. retrieving or displaying) gestational age (GA), and chronological age..
RESPONSE: The examiner respectfully maintains the prior art rejection. Note new mappings within the Office Action above Martin et al. was combined with Tonnsen et al. for teaching “calculating gestational age of an infant”. See Martin et al. paragraph 0052, “the processor 104 may perform a statistical analysis to produce a statistical prediction or compute a likelihood quantifying a risk of the patient” (processor calculates or computes analysis); paragraph 0073, “data collection in HRA infants included: Gestational Age (GA) at birth, Post Menstrual AGE (PMA), Chronological Age”, also se paragraph 0039 “detecting within the first year of life, and as early as the neonatal period, within approximately a month of birth”]. .
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Note attached form PTO-892.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GRETA L ROBINSON/Primary Examiner, Art Unit 2163
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