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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 12-20 in the reply filed on 03/09/2026 is acknowledged.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/09/2026.
Examiner’s note: As recited in the Restriction Requirement mailed on 02/18/2026, claims 13-18 are interpreted as depending from claim 12 due to the claims reciting specifics regarding the composite DC signal, which is only recited in claim 12. A telephone conversation with Amy Embert on 03/16/2026 confirmed this interpretation.
Status of Claims
Claims 12-20 are hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/04/2024 is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 14, the claim recites “wherein the analysis of the composite DC signal comprises comparing, by the processor, a result of the analysis with a threshold …”. In light of the specification, it is currently unclear how the analysis can comprise using a result of the analysis. Is “a result of the analysis” a prior analysis, and the step of analyzing the composite DC signal uses the prior analysis? Does analyzing the composite DC signal include performing a first analysis, and then performing a second analysis that includes comparing a result of the first analysis with a threshold? For the purposes of examination, a first analysis is performed, and a second analysis is performed, which includes comparing a result of the first analysis with a threshold. It is recommended to the Applicant to amend the claims to clearly define and differentiate between “the analysis” and “a result of the analysis”.
Regarding claim 20, line 3 and line 5 recite “the composite DC signal”. However, claim 19 recites “a modeled composite DC signal” and “a measured composite DC signal”. In light of the specification, it is currently unclear what “the composite DC signal” is referring to/encompassing. Does “the composite DC signal” encompass one or both of the previously recited DC signals? For the purposes of examination, “the composite DC signal” encompasses either “a modeled composite DC signal” or “a measured composite DC signal”.
Regarding claim 20, lines 5-6 recites “wherein analysis of the composite DC signal is responsive to …”. In light of the specification, it is currently unclear what “analysis” is referring to. Is the analysis referring to the comparing step of claim 19? Is the analysis a different step? For the purposes of examination, “wherein analysis of the composite DC signal is responsive to …” is referring to “comparing, by the processor, the modeled composite DC signal and the measured composite DC signal”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 13-18, the claims currently depend from claim 10, drawn to a non-elected invention. Therefore, the claims fail to include all the limitations of the claim upon which it depends. As recited in the restriction requirement mailed on 02/18/2026, and reiterated above, claims 13-18 are being interpreted as being dependent from claim 12 for the purposes of examination.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claim 12:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 12 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 12 recites an abstract idea. In particular, the claim recites the following:
Analyzing the composite DC signal; and
Determining an indication of fetal hemoglobin oxygen saturation level responsively to a result of the analysis of the composite DC signal.
These elements recite in claim 12 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Analyzing the composite DC signal and determining an indication of fetal hemoglobin oxygen saturation level responsively to a result of the analysis of the composite DC signal is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can reasonably view the composite DC signal on a piece of paper and make a mental determination, for example by comparing the DC signal to a known fetal hemoglobin oxygens saturation level, to determine an indication for the composite DC signal. There is nothing to suggest an undue level of complexity in the analysis and determining steps.
Prong Two: Claim 12 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a processor …”), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “a photodetector …”); the post-solution activity of: (e.g. “facilitating, provision of the indication to a user” (with no structure recited)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a photodetector ….” is well-understood, routine, and conventional, as disclosed by Wang et al. (US 20110218413 A1) - para. [0037], para. [0065]).
Further, “a processor” does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 12 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, and post solution steps with no structure recited, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and 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 taking 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.
Analysis of independent claim 19:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 19 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 19 recites an abstract idea. In particular, the claim recites the following:
Comparing the modeled composite DC signal and the measured composite DC signal; and
Determining, an indication of fetal hemoglobin oxygen saturation level responsively to a result of the comparing.
These elements recited in claim 19 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Comparing the modeled composite DC signal and the measured composite DC signal and determining an indication of fetal hemoglobin oxygen saturation level based on a result of the comparing is drawn to an abstract idea that is capable of being performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art could reasonably view a modeled composite DC signal, with a known oxygen saturation level, and a measured composite DC signal on a piece of paper, and make a determination regarding the oxygen saturation level of the measured signal. There is nothing to suggest and undue level of complexity in the comparing and determining steps.
Prong Two: Claim 19 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a processor …”), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “a photo detector …”); the post-solution activity of: (e.g. “facilitating provision of the indication to a user” (with no structure recited)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a photodetector ….” is well-understood, routine, and conventional, as disclosed by Wang et al. (US 20110218413 A1) - para. [0037], para. [0065]).
For example, “generating a modeled composite DC signal …” is well-understood, routine, and convention, as disclosed by Thomas et al. (US 5435309 A) - col. 15, line 50 - col. 16, line 19, col. 26, lines 8-21.
Further, “a processor” does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 19 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, and post-solution steps without reciting structure, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and 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 taking 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.
Analysis of the dependent claims:
Claims 13-18 and 20 depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the analysis of the composite DC signal comprises performing, by the processor, a trend analysis that determines relative changes in the composite DC signal over time” (claim 13), “the analysis of the composite DC signal comprises comparing, by the processor, a result of the analysis with a threshold value for the composite DC signal, wherein the indication includes a result of the comparison” (claim 14), “analyzing, by the processor, the processed composite DC signal to determine changes in the processed composite DC signal over the period of time; determining, by the processor, a trend of changes to the processed composite DC signal over time” (claim 15), “analyzing, by the processor, the composite DC signal to determine changes in the composite DC signal over a time period; determining, by the processor, a trend of changes to the composite DC signal over time” (claim 16), “determining, by the processor, whether an intensity of the fetal AC signal is above a threshold intensity value, wherein analysis of the composite DC signal is responsive to a determination that the intensity of the fetal AC signal is above the threshold intensity value” (claim 17), “determining, by the processor, whether an intensity of the fetal AC signal is above a threshold intensity value, wherein analysis of the composite DC signal is responsive to a determination that the intensity of the fetal AC signal is above the threshold intensity value” (claim 20)),
Further describe the pre-solution activity (or the structure used for such activity) (“receiving, by the processor, an indication of changes to a maternal DC signal over a period of time; processing, by the processor, the composite DC signal to remove changes to a maternal component of the composite DC signal, thereby generating a processed composite DC signal” (claim 15), “receiving, by the processor, an indication of a fetal AC signal prior to receipt of the composite DC signal” (claim 17), “the composite DC signal is obtained transabdominally” (claim 18), “receiving, by the processor, an indication of a fetal AC signal prior to receipt of the composite DC signal” (claim 20)),
Further describe the computer implementation (“processor”), and
Further describe the post-solution activity (“providing, by the processor, the trend to the user” (claim 15), “providing, by the processor, the trend to the user” (claim 16)) (recited at a high level of generality).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. 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 improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 12-20 are rejected.
Prior Art Analysis
There is no prior art rejection. Claims 12-20 are rejected, as recited above. The closest prior art made of record includes: Wang et al. (US 20110218413 A1), hereinafter referred to as Wang, Ghiasi et al. (US 20200245879 A1), hereinafter referred to as Ghiasi, and Thomas et al. (US 5435309 A), hereinafter referred to as Thomas.
Examiner’s note: “composite DC signal” is being interpreted as described within the specification, specifically, as the maternal and fetal steady (non-pulsatile/non-time varying) component, as recited in para. [0032] of the specification filed 01/04/2024.
Wang teaches a method of measuring comprising: receiving, by a processor, a composite DC signal from a photodetector communicatively coupled to the processor, the composite DC signal corresponding, by the processor, to an optical signal incident upon an abdomen of a pregnant mammal and a fetus contained therein that has emanated from the pregnant mammal’s abdomen and been detected by the photodetector (Fig. 2, elements 42, 44, Fig. 4, para. [0056], para. [0072]). Wang teaches the composite DC signals are filtered to generate AC signals (para. [0072]), which are then used in subsequent analysis to determine fetal hemoglobin oxygen saturation levels (Fig. 4, para. [0077]). However, Wang does not disclose, teach, or reasonably suggest “analyzing, by the processor, the composite DC signal; determining, by the processor, an indication of fetal hemoglobin oxygen saturation level responsively to a result of the analysis of the composite DC signal; and facilitating, by the processor, provision of the indication to a user”, and “comparing, by the processor, the modeled composite DC signal and the measured composite DC signal; determining, by the processor, an indication of fetal hemoglobin oxygen saturation level responsively to a result of the comparing; and facilitating, by the processor, provision of the indication to a user”.
Ghiasi teaches a method comprising: receiving, by a processor, a composite signal from a photodetector communicatively coupled to the processor, the composite signal corresponding, by the processor, to an optical signal incident upon an abdomen of a pregnant mammal and a fetus contained therein that has emanated from the pregnant mammal’s abdomen and been detected by the photo detector (Fig. 1, element 121, para. [0034]). Wang generically teaches the pulse oximetry computation is performed on a DC component and an AC component of the fetal signal (para. [0012]). However, Ghiasi does not disclose, teach, or reasonably suggest “analyzing, by the processor, the composite DC signal; determining, by the processor, an indication of fetal hemoglobin oxygen saturation level responsively to a result of the analysis of the composite DC signal; and facilitating, by the processor, provision of the indication to a user”, and “comparing, by the processor, the modeled composite DC signal and the measured composite DC signal; determining, by the processor, an indication of fetal hemoglobin oxygen saturation level responsively to a result of the comparing; and facilitating, by the processor, provision of the indication to a user”.
Thomas teaches a method of determining blood oxygen saturation of a fetus using a model based on known values of blood oxygen saturation (col. 15, line 50 - col. 16, line 19, col. 26, lines 8-21). However, Thomas does not disclose, teach, or reasonably suggest “generating, by a processor, a modeled composite DC signal, the modeled composite DC signal corresponding, by the processor, to a modeled optical signal incident upon an abdomen of a pregnant mammal and a fetus contained therein that has emanated from the pregnant mammal’s abdomen and been detected”, in combination with the other elements of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791