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 Arguments
Applicant's arguments and amendments regarding the 101 rejection filed 12/4/2025 have been fully considered but they are not persuasive. The Applicant amended the claims to have a sensor unit with at least a portion of the sensors being at least partially enclosed by housing and an attachment mechanism configured to fasten at least a portion of the housing to the neonates skin. These parts are considered conventional, well-known characteristics of generic wearable sensor devices in view of Carpenter (US 2020/0281526 A1) (eg. Abstract, Para. 77, Fig. 6) and Jung (US 2022/0265206 A1) (eg. Para. 66, Fig. 2a-b). With regards to the technical solution, the Applicant argued that the technical solution is monitoring and predicting the likelihood of sudden unexpected postnatal collapse. Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) tells us that the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered law of nature (or natural phenomenon or abstract idea) cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. The collection of data and outputting alerts/results are considered insignificant extrasolution activities of necessary data gathering and outputting (see MPEP 2106.05(g)). The Examiner recommends incorporating the newly amended claim 2 into the independent claims to overcome the 101 rejection.
Applicant’s arguments and amendments, see pages 7-8 and 11-17, filed 12/4/2025, with respect to claims 1-14, and 16-20 have been fully considered and are persuasive. The 112 and 103 rejections of claims 1-14 and 16-20 has been withdrawn.
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 1-20 are rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 1-13 recite an apparatus and claims 14, and 16-20 recite a method.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites analyzes pleth and motion data (observation/analysis), estimates an instantaneous SpO2 (analysis/calculation/determination), characterizes the instantaneous SpO2 (determination). These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The wearable is generically recited in view of specification para. 40-42 and para. 50 (generic processor). The IMU and PPG sensors at least partially embedded in a housing are generically recited and amount to mere necessary data gathering, which is an insignificant extrasolution activity (see MPEP 2106.05(g)). The fastener is a generic affixing member on wearables sensor devices.
The dependent claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process) except claims 2 and 15-16 the Examiner recommends incorporating language from claim 16 into independent claims 1 and 14. The tactile stimulus/supplemental oxygen are treatment steps that would bring the abstract idea into a practical application.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? NO, The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)). The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). The sensor unit with at least a portion of the sensors being at least partially enclosed by housing and an attachment mechanism configured to fasten at least a portion of the housing to the neonates skin are considered conventional, well-known characteristics of generic wearable sensor devices in view of Carpenter (US 2020/0281526 A1) (eg. Abstract, Para. 77, Fig. 6) and Jung (US 2022/0265206 A1) (eg. Para. 66, Fig. 2a-b).
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.
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/MICHAEL J LAU/Examiner, Art Unit 3796