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, see pages 6-8, filed 06/01/2026, with respect to 35 U.S.C. 101 have been fully considered and are persuasive. Applicant argues on pages 6-8 that “the Present Action relies on several references to assert that non-invasive SvO2 measurement from PPG signals is well-understood, routine, and conventional (WURC) - (1) art that invasively measures SvO2, and (2) and art that non-invasively measures SvO2 by artificially injecting an electrical signal onto the PPG signal.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application. Specifically, the reference of Zhang that states that there is no existing non-invasive continuous device for measuring SVO2 (see remarks page 7 filed 06/01/2026) is insufficient as to why the instant claims are not WURC because the instant claims are directed to a computer logic system for processing the mental process. The arguments regarding invasive and non-invasive monitoring are not new, as provided by the references, but it is further noted that the instant claims are directed to a computer logic system and not a system or device with different components.
Applicant argues that Zhang and Chase require the injection of an artificial signal to determine SVO2 and that they require the invasive blood gas to calibrate their systems (page 7 of the remarks filed 06/01/2026). Examiner disagrees because Zhang is using PPG signals, which are non-invasive to determine SvO2 and the use of an artificial signal in Zhang has no effect in the subject matter eligibility analysis of the instant claims under 101. The rejection of the claims has been maintained.
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 1-14 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 and 14 has been amended to include the limitation, " without modulating an artificial signal onto a person's venous signal ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for outputting venous oxygen saturation. However, the specification does not provide support for no modulation of artificial signal onto a venous signal. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " without modulating an artificial signal onto a person's venous signal”. Therefore, the new claim limitations introduce new matter.
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 1-14 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 claims 1 and 14, it is unclear what the breadth of “artificial signal” may be because a PPG sensor emits a light signal to the skin, which may be considered an artificial signal. There does not exist a PPG that does not inject an artificial light signal so it is unclear how no modulation of artificial signal is applied.
Regarding claims 1 and 14, it is unclear how the artificial signal can be injected into a venous signal. It is unknown what Applicant is defining a “venous signal”.
Regarding claims 1 and 14, it is unclear if the “person” of line 6 is the same or different than the “person” of line 2.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 1 and 20 recites a step calculating arterial oxygen saturation by comparing the composite SPOS signals measured at different wavelengths of light… comparing the sub-sampled composite SPOS signals measured at different wavelengths of light to the calculated arterial oxygen saturation to determine venous oxygen saturation, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a computer logic system), and determining venous oxygen saturation do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and assessing intra-arterial fluid volume, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 14 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 14, the following step is an abstract idea:
“calculating arterial oxygen saturation by comparing the composite SPOS signals measured at different wavelengths of light… comparing the sub-sampled composite SPOS signals measured at different wavelengths of light to the calculated arterial oxygen saturation to determine venous oxygen saturation”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could distinguish between cardiac cycles based on contractions, take a derivative of a signal, calculate atrial oxygen saturation and comparing sub-sampled composite SPOS signals at different wavelengths to determine venous oxygen saturation.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 14, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a computer logic system”, “a system”, “display device”, and “a device” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “electrodes”, “PPG sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “EKG”, “PPG”, “prior R-to-R and current R-to-R”, “summing and averaging”, “derivative of the composite signal”, “similarity in durations”, “cardiac cycles”, “ output an indication”, “venous oxygen saturation”, and “sorting PPG signals” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a computer logic system”, “a system”, “display device”, and “a device” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “electrodes”, “PPG sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “EKG”, “PPG”, “prior R-to-R and current R-to-R”, “summing and averaging”, “derivative of the composite signal”, “similarity in durations”, “cardiac cycles”, “ output an indication”, “venous oxygen saturation”, and “sorting PPG signals” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 14, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the computer logic system, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The electrodes and PPG sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]). The measuring of venous oxygen saturation is well-understood routine and conventional in the diagnostic art, as seen in the following cited references: Benni et al. (US 20120065485) shows the ability to determine SvO2 ([0003] and [0014]), Chase et al. (US 20180055427) shows an apparatus for non-invasive measurement of venous oxygen saturation using an oximeter and pressure transducer (Abstract and [0013]), and Zhang et al. (“A new method for noninvasive venous blood oxygen detection” BioMedical Engineering OnLine volume 15, Article number: 84 (2016)) shows the ability to calculate and measure venous oxygen saturation using PPG signals (Abstract and Methods).
Dependent claims 2-13 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to further extra-solution activity (claims 2-7 and 13) and to generic structure (claims 8-12), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-14 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Conclusion
Claims 1-14 have overcome the prior art but are still rejected under 35 U.S.C. 101.
The following is a statement of reasons for the indication of the claims overcoming the prior art:
The binning of PPG segments based on prior and current R-to-R durations and the generating composite SPOS to compare the composite SPOS signals at different wavelengths to determine arterial and venous oxygen saturation are not conventionally relied upon in determining venous oxygen saturation and are therefore allowable over the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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