DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 March 2026 has been entered.
Claims 1-15 are pending in the present application. Claims 1, 2, 6, 7, 11, and 12 were amended in the response filed 02 March 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The disclosure does not appear to clearly describe “calculating gestational age (GA) of said infant”, the disclosure does describe a gestational age of said infant; however does not appear to use the term “calculating”. Clarification is requested...
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:
calculating gestational age (GA) of said infant:
receiving and storing heart rate (HR) pattern data corresponding to said infant of said (PMA) for a predetermined time period, 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 follow a conclusion of said calculating of said GA 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 excpicity teach calculating a gestational age of said infant. They do discuss gestational age of infants. However Martin et al. teaches calculation of a gestational age of an infant [note: paragraph 0190, “Gestational age was calculated based on the last menstrual period in rounded weeks”, also se paragraph 0162 autism risk]. 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.
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 02 March 2026 have been fully considered but they are not persuasive.
ARGUMENT: The prior art does not teach the amended feature of calculating gestational age (GA) of said infant.
RESPONSE: Note newly cited reference Martin et al.combined with Tonnson et al. teaches the amended feature of calculating gestational age of an infant.See Martin et al. oaragraph 0190. Tonnsen et al. is concerned with detecting risk for autism in infants which include a variety of ages [see: page 1 and 3, figures 1-3]..
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Note attached form PTO-892.
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/GRETA L ROBINSON/Primary Examiner, Art Unit 2163