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 6-9, filed 10/01/2025, regarding the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant sets forth deficiencies for each of the references cited by the Examiner to show that determining venous oxygen saturation non-invasively is Well-Understood, Routine, and Conventional (WURC). Regarding Zhao, Applicant argues on page 6 that “Zhao provides no teaching how ECG signals can be applied to improved oximetry techniques.” Regarding Benni, Applicant argues on pages 6-7 that “NIRS is a different sensing technique than PPG sensing system… the techniques of Benni cannot be applied to the instant PPG systems to determine venous oxygen saturation non- invasively from a PPG signal.” Regarding Zhao, Examiner noted that obtaining ECG signal from ECG sensors are well-understood, routine, and conventional, and was cited as such because the ECG signal is used for binning, and not the extraction of venous oxygen saturation. Further, although Applicant is correct to point out PPG sensors not used to obtain venous oxygen saturation, Examiner noted Benni to show that non-invasive monitoring of venous oxygen saturation is not a technological advancement and therefore does not add significantly more to the abstract idea as there are multiple ways of non-invasively monitoring venous oxygen saturation.
Applicant then argues on page 7 that “while Chase does relate to deriving SvO2 from a PPG signal, the techniques of Chase are not wholly non-invasive. while Chase does relate to deriving SvO2 from a PPG signal, the techniques of Chase are not wholly non-invasive. As noted by Chase, “conventional pulse oximeters are restricted to estimation of SaO2 only. Coupling estimation of peripheral venous blood oxygen saturation (SvO2) with estimation of SaO2 would enable assessment of local oxygen extraction (O2E) according to (O2E=SaO2-SvO2) and any related metrics.”… the techniques of Chase require the usage of an artificial pulse generator to be able to derive SvO2… Chase discloses that the calibration/correlation equation can be applied to an estimation of SvO2 provided by the pulse oximeter (called SovO2 in Chase) to provide a more accurate estimation of SvO2… In the approach of Chase, invasive SvO2 measurements are still needed to build the calibration model.” Applicant is correct to point out to the technical application of Chase is different than the instant invention, however, a PPG signal is still extracted for the estimation of SvO2 estimation ([0023] and [0024]). Even if the PPG signal is altered due to signal processing adjustments, it is still well-understood, routine, and conventional to us non-invasive PPG sensors (pulse oximetry and optoelectronic sensor (using LEDs and photodetectors)) for estimating SvO2. Further, even though invasive methods of obtaining venous oxygen saturation, it does not take away the ability to take venous oxygen saturation non-invasively via LEDs and photodetectors.
Applicant then argues on page 8 that “like Chase, Zhang discloses modulating a stimulus onto the venous blood signal to extract characteristics of the superimposed signal to derive SvO2. See id. (“The experimental results indicate that the method of addition artificial stimulation can successfully transform the vein interference signal of pulse oxygen saturation measurement into useful signal to venous oxygen saturation measurements without compromising the pulse oxygen measurement.”). More particular, Zhang discloses that “the peak of artificially stimulated signal is used as input data to calculate Mixed-SpO2 in the normal way which is same to the calculation of SpO2.” Page 5 (emphasis added). Like Chase, Zhang also discloses that this determination is derived from based on artificial stimulation. Again, the instant techniques do not rely on artificial stimulation. Thus, the instant techniques can be more readily applied than the techniques of Chase and Zhang.” Similar to Chase, Applicant is correct to point out to the technical application of Zhang is different than the instant invention, however, a PPG signal is still extracted for the estimation of SvO2 estimation. Even if the PPG signal is used alongside the stimulus and using peaks, it is still well-understood, routine, and conventional to use non-invasive PPG sensors (using LEDs and photodetectors) for estimating SvO2.
Applicant lastly argues on page 9 that “Applicant provided those steps as example features that “reflect” the improvement provided by the specification. That said, it is the claim as a whole that needs to be evaluated as reflecting the improvement. /d. (“demonstrating that the claim as a whole integrates the exception into a practical application”). Here, there Present Action itself identifies many “additional elements” that when viewed in the context of the claim as a whole, reflect the above-described improvement in the art of non-invasive SvO2 measurement.” Examiner disagrees. Examiner cites MPEP 2106.05(d)(I)(2) that states A factual determination is required to support a conclusion that an additional element (or combination of additional elements) is well-understood, routine, conventional activity. Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018)… As such, an examiner should determine that an element (or combination of elements) is well-understood, routine, conventional activity only when the examiner can readily conclude, based on their expertise in the art, that the element is widely prevalent or in common use in the relevant industry. The analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification. See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016). In the instant case, in the field of non-invasive monitoring of venous oxygen saturation, the “additional element” of the PPG sensor and PPG signal extraction is WURC, as noted in the references provided in the rejection.
Therefore, the rejection is maintained.
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.
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.
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
/ALLEN PORTER/Primary Examiner, Art Unit 3796