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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/06/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 04/06/2026. As directed by the amendment: Claims 21-22, and 24-26 have been amended, claims 1-20 have been cancelled, and no claims have been added. Thus, claims 21-27 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 7-9, filed 04/06/2026, under 35 U.S.C. 112(b) have been fully considered and are persuasive. Applicants arguments on page 9, and the amendments obviate the rejection of record. Therefore, the rejection is withdrawn.
Applicant's arguments, see pages 7-9, filed 04/06/2026, under 35 U.S.C. 112(a) have been fully considered. Applicant asserts on pages 8-9, that the amendments recite two biological signals, the new amendments regarding preprocessing, and the wavelet coefficient conversion into time-domain PAP has support in the instant specification. Examiner disagrees based on the updated rejections presented below. Therefore, the rejection has been updated below.
Applicant's arguments, see pages 9-11, filed 04/06/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant asserts on page 10 that “mental evaluation of information or a generalized prediction of a physiological parameter. Rather, claim 21 recites a specific machine-implemented signal-processing and waveform-reconstruction workflow performed by a central data processing box operatively coupled to a plurality of noninvasive sensors”.
Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
Applicant then argues on page 10 that “claim 21 requires a plurality of noninvasive sensors configured to collect corresponding waveform records from a patient. The specification explains that the disclosed apparatus predicts a subject's hemodynamics parameter, ordinarily obtained from an implanted sensor or catheter, using noninvasively acquired biosignals obtained from sensors attached to the subject's skin. The written description further describes a noninvasive multi-sensor device and a central data processing box that collects multiple input signals and processes those signals to estimate PAP and other hemodynamic parameters.”
Examiner disagrees because Chen (US 20180028144) teaches that the use of routine medical equipment such as stethoscopes have been used for rapid screening with high accuracy, which typically already include the combination of ECG and PCG, obtained from a microphone and ECG sensor non-invasively (Abstract and [0003]), making this combination well-understood, routine, and conventional. Maidens (US 20230134653) teaches that the estimation of PAP from the combination of ECG and PCG non-invasively would allow for higher reliability ([0005]).
Applicant then argues on page 10 that “the claim requires preprocessing the waveform
records, selecting waveform records that satisfy a continuous-data requirement over a 1-second
time window, performing the recited filtering operations, fragmenting the selected waveform
records into multiple overlapping sample windows using an overlapping sliding window method, extracting wavelet scattering transform features from the fragmented waveform sample windows, applying a trained model to those features to generate wavelet coefficients for reconstruction of a pulmonary artery pressure waveform, converting the generated wavelet coefficients into time-domain PAP waveform data, and outputting the resulting continuous PAP waveform in mmHg… The written description explains that the wavelet scattering feature extraction method
provides an invariant representation of the original input signals, that the prediction outcomes are
wavelet coefficients, and that those coefficients are converted back into time-domain signals
such that the predicted time-domain signals are smooth waveforms. Thus, the claimed trained-
model step is not presented as a black-box conclusion or mere mental judgment. Instead, it is part
of a disclosed technical reconstruction pipeline in which specified signal features are transformed
into specified intermediate outputs and then into reconstructed waveform data”
Examiner disagrees because selecting and fragmenting waveforms is considered a mental process and applying the wavelet scattering and trained model is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f). Examiner notes that having written description for describing the wavelet scattering does not have bearing on the determination of patent eligibility.
Applicant then argues on page 11 that “claim 21 is not directed to merely observing information and mentally evaluating it. Claim 21 requires a specific noninvasive multi-sensor apparatus and a specific sequence of machine-performed signal-processing operations that transform multiple noninvasively acquired physiological waveform records into a reconstructed PAP waveform output for clinical review. Without conceding with the Examiner's determination of abstract idea, Applicant submits that the claim therefore integrates any alleged abstract idea into a practical application.”
Examiner disagrees because the instant claims recite a mental process of segmenting and fragmenting the waveforms. Further, the sensors are generic gathering structure that produce waveforms that are extra-solution activity. These additional elements do not integrate the judicial exception into practical application.
Applicant lastly argues on page 11 that “Applicant respectfully submits that, when considered as a whole, amended claim 21 is directed to a technological improvement in noninvasive hemodynamic monitoring, name generating a continuous PAP waveform from noninvasively acquired waveform records through the recited signal-processing and waveform-reconstruction workflow.”
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. Therefore, the rejection is maintained.
Claim Objections
Claim 21 is objected to because of the following informalities: the phrase “selected from the group consisting of” is missing the semicolon and should recite “selected from the group consisting of:”. Appropriate correction is required.
Regarding claim 21, for clarification, the selection of a waveform “by requiring continuous data over a time window of 1 second” does not establish what is selected and how to do the selecting of data. Examiner notes that the time window of 1 second is not claimed as a selection but as a requirement.
Claim 25 is objected to because of the following informalities: the phrase “around wrist of the patient” is missing an article and should recite “around a wrist of the patient””. Appropriate correction is required.
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 21-27 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 21 has been amended to include the limitation, " a plurality of noninvasive sensors configured to collect corresponding waveform records from the patient, wherein the plurality of noninvasive sensors comprises at least two sensors… convert the generated wavelet coefficients into time-domain PAP waveform data ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for multiple sensors in the chest area and the generation of the time domain PAP signal based on ABP, CVP, RESP, PPG, and ECG, by using features from all of these physiological signal ([0072] discloses the use of 1008 features) using wavelet scattering transform to produce the PAP segment ([0072] of the PG Pub). However, the specification does not provide support for the at least one noninvasive sensor disposed at one or more distinct anatomical locations selected to optimize signal acquisition, each of the at least one noninvasive sensor configured to collect a corresponding waveform record… the apparatus is specifically configured such that the processing of the collected waveform records obtained through the at least one noninvasive sensor into a predicted continuous PAP. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " a plurality of noninvasive sensors configured to collect corresponding waveform records from the patient, wherein the plurality of noninvasive sensors comprises at least two sensors… convert the generated wavelet coefficients into time-domain PAP waveform data”. Therefore, the new claim limitations introduce new matter.
Claims 21-27 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.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted).It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Claims 21-27 fails to sufficiently describe the trained model in enough detail for one skilled in the art to have sufficient written description. The mere statement and recitation of the iterative training process using learning parameters and input features in their usage of any regression models such as Neural Networks and Bayes classifiers, among many other in claim 21, and [0043] and [0052] of the specification provides insufficient detail to the type of data that is used to train the model and the algorithm used to predict PAP waveform. There is insufficient disclosure to what the input features are and how the data is extracted for determining the learning parameters. Further, the instant specification fails to detail the way in which each of the machine learning models are in the training of the physiological data to achieve the PAP waveform. It is further undisclosed how a continuous PAP waveform is produced from the wavelet and CNN of [0067]. There is insufficient disclosure as to what the features that are looked at when inputted into the model, the output of the model, how the data is trained, and what is extracted from the wavelet transform. Therefore, claims 21-27 do not provide sufficient detail for one to replicate and understand the intended function that’s being performed to show possession of the claimed invention.
Claims 21-27 fails to sufficiently describe the quality checking, validation, and electrode adhesion during preprocessing in enough detail for one skilled in the art to have sufficient written description. The mere statement and recitation of “preprocess input signals, including quality checking, noise reduction, electrode adhesion, and validation.” in claim 21, and [0046] of the specification provides insufficient detail to how the input signals are evaluated for the quality checking, validation, and electrode adhesion. There is insufficient disclosure to what within the input signal are analyzed to determine quality checking, validation, and electrode adhesion. Further, the instant specification fails to detail the steps, process, and/or calculations required for quality checking, validation, and electrode adhesion. There is insufficient disclosure as to what the features that are looked at from the input signal. Therefore, claims 21-27 do not provide sufficient detail for one to replicate and understand the intended function that’s being performed to show possession of the claimed invention.
Claims 21-27 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 analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claim 21 fails to sufficiently describe the use of two collected waveform from two noninvasive sensor used in the wavelet transform and AI model to generate the continuous time domain PAP waveform in enough detail for one skilled in the art to have possession of the broadly claimed genus. Although the instant specification discloses the generating of a continuous PAP waveform using physiological parameters, the instant specification discloses that this generation of the PAP signal is based on ABP, CVP, RESP, PPG, and ECG, by using features from all of these physiological signal ([0072] discloses the use of 1008 features), and implementing the wavelet scattering transform to produce the time domain continuous PAP segment ([0072] of the PG Pub). Therefore, the use of ALL of the disclosed physiological parameters must be used to generate the PAP segment and NOT at least two non-invasive sensors. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic method of using at least two non-invasive sensors to generate the time-domain continuous PAP signal. The instant specification fails to disclose any other embodiment/species, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, claims 21-27 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed.
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 21-27 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 21, it is unclear if the phrase “noise reduction” of line 18 claim 21 is the same or different than the preprocessing of the “noise reduction” of lines 8-9 of claim 21.
Regarding claim 21, it is unintelligible as to how “electrode adhesion” may be considered as a preprocessing step, when electrode adhesion is the sticking of electrodes on a user.
Regarding claim 21, a bandpass filter for suppressing 50Hz is inconsistent because the suppressing of a single frequency is a “band-stop” or “notch”, and not “band-pass filtering”.
Claim 21 recites the limitation "the fragmented waveform sample windows" in page 4 lines 9-10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 23-27, it is unclear if the phrase “the apparatus comprises X sensor” further narrows claim 21’s Markush grouping of “at least two sensors selected from the group consisting of”, or are the claims adding new sensors.
Regarding claim 23, it is unclear if the phrase “PPG sensor” of line 1 claim 23 is the same or different than the “PPG sensor” of claim 21.
Regarding claim 24, it is unclear if the phrase “ECG sensor” of line 1 claim 23 is the same or different than the “ECG sensor” of claim 21.
Regarding claim 25, it is unclear if the phrase “ICG sensor” of line 1 claim 23 is the same or different than the “ICG sensor” of claim 21.
Regarding claim 25, it is unclear how the one ICG sensor can be place on the chest and neck areas when there is only 1 ICG sensor and two different locations.
Regarding claim 26, it is unclear if the phrase “PVPW sensor” of line 1 claim 23 is the same or different than the “PVPW sensor” of claim 21.
Regarding claim 27, it is unclear if the phrase “PAPW sensor” of line 1 claim 23 is the same or different than the “PAPW sensor” of claim 21.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 23-27 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claims 23, the phrase “PPG sensor disposed on a finger of the patient” is claiming the subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “PPG sensor configured to be disposed on a finger of the patient”.
Regarding claims 24, the phrase “ECG sensor disposed on or around a chest area of the patient” is claiming the subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “ECG sensor configured to be disposed on or around a chest area of the patient”.
Regarding claims 25, the phrase “ICG sensor disposed on the chest and neck of the patient” is claiming the subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “ICG sensor configured to be disposed on the chest and neck of the patient”.
Regarding claims 26, the phrase “PVPW sensor disposed around wrist of the patient” is claiming the subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “PVPW sensor configured to be disposed around wrist of the patient”.
Regarding claims 27, the phrase “PAPW sensor disposed around wrist of the patient” is claiming the subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “PAPW sensor configured to be disposed around wrist of the patient”.
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 21-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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 21 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claim 21, the following step is an abstract idea:
“select the waveform records by requiring continuous data over a time window of 1 second… fragment the selected waveform records into multiple overlapping sample windows using an overlapping sliding window method, wherein each sample window represents a discrete segment of the selected waveform records”, 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 select the waveform records and fragmenting the windows by observing and evaluating the data.
“perform noise reduction on the selected waveform records by applying a bandpass filter to suppress 50 Hz interference and a low-pass filter with a cutoff frequency of 0.5 Hz” , which is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In this case, the filtering of waveforms requires the use of the following equation
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, which is a mathematical concept.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 21, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “hardware processor”, “data interface/display”, “central data processing box” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
It is noted that the wavelet scattering transform and trained model are by definition automating the human thinking process with a computer.
- “noninvasive sensor”, specifically for “ECG”, “PPG”, “PAP”, “RESP”, “ICG”, “PCG”, PVPW”, “PAPW”, “echocardiogram”, “airway resistance”, and “blood sugar level”, sensors are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “noninvasive input variable”, “waveform records”, “windows”, “quality checking”, “noise reduction”, “electrode reduction”, “validation”, “ECG”, “PPG”, “input features”, “optimal learning parameters”, “discrete segment”, “PAP”, “RESP”, “ICG”, “PCG”, PVPW”, “PAPW”, “echocardiogram”, “airway resistance”, “blood sugar level”, “50/0.5 Hz interference”, “(overlapping) sample windows”, “fragmented waveform sample windows”, “discrete segment”, “features”, “wavelet coefficients”, “time-domain/continuous PAP waveform”, “pressure values mmHg”, and “clinical review” 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)];
- “apply wavelet scattering transform” is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “hardware processor”, “data interface/display”, “central data processing box” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
It is noted that the wavelet scattering transform and trained model are by definition automating the human thinking process with a computer.
- “noninvasive sensor”, specifically for “ECG”, “PPG”, “PAP”, “RESP”, “ICG”, “PCG”, PVPW”, “PAPW”, “echocardiogram”, “airway resistance”, and “blood sugar level”, sensors are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “noninvasive input variable”, “waveform records”, “windows”, “quality checking”, “noise reduction”, “electrode reduction”, “validation”, “ECG”, “PPG”, “input features”, “optimal learning parameters”, “discrete segment”, “PAP”, “RESP”, “ICG”, “PCG”, PVPW”, “PAPW”, “echocardiogram”, “airway resistance”, “blood sugar level”, “50/0.5 Hz interference”, “(overlapping) sample windows”, “fragmented waveform sample windows”, “discrete segment”, “features”, “wavelet coefficients”, “time-domain/continuous PAP waveform”, “pressure values mmHg”, and “clinical review” 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)];
- “apply wavelet scattering transform” is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
The additional elements of claim 21, 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, processor, 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 additional elements of data gathering using sensors are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional. The ECG sensor, EKG sensor, pulse oximeter sensor, temperature sensor, blood pressure sensor, accelerometer or an acoustic 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]), Boppart (US 20090306489) teaches the use of a pulse oximetry sensor to measure oxygen saturation ([0011]), Shin et al (US 20060253041) teaches a blood pressure sensor for measuring blood pressure ([0011]-[0012]), Roovers et al (US 20170007166) teaches an accelerometer for detecting motion signals ([0008]), and Gopinathan et al (US 20210338190) teaches a heart sound sensor for detecting heart sounds ([0196]-[0198]). Further, Chen (US 20180028144) teaches that the use of routine medical equipment such as stethoscopes have been used for rapid screening with high accuracy, which typically already include the combination of ECG and PCG, obtained from a microphone and ECG sensor non-invasively (Abstract and [0003]), making this combination well-understood, routine, and conventional. Maidens (US 20230134653) teaches that the estimation of PAP from the combination of ECG and PCG non-invasively would allow for higher reliability ([0005]).
Dependent claims 22-27 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 21. The dependent claim limitations are directed to generic gathering structure (claims 23-27) and to data/insignificant extra-solution activity (claim 22), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 21-27 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Conclusion
Claims 21-27 overcome the prior art but are still rejected under 35 U.S.C. 101, 35 U.S.C. 112(b), and 35 U.S.C. 112(a).
The following is a statement of reasons for the indication of the claims overcoming the prior art:
The extracting of features of fragmented windows, obtained from wavelet scattering transform of one or more fragmented window from ECG, PPG, RESP, or an additional noninvasive input variable are not conventionally relied upon in generating a predicted continuous PAP signal waveform and are therefore free from 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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