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 6-7, filed 08/13/2025, under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant cites different places in the PG pub of the claims to show that the claims have support in the instant specification. Examiner notes that Applicant has failed to address the issues brought up by the Examiner in the rejection. 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 in page 6 of the instant specification provides insufficient detail to the type of data that is used to train the model and the algorithm used to predict PAP waveform. 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. Applicant fails to disclose 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, the rejection is maintained.
Applicant’s arguments, see page 7, filed 08/13/2025, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant's arguments, see pages 7-9, filed 08/13/2025, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant asserts on page 7 that “The claim recites concrete, physical components — noninvasive medical sensors and a central data processing box with at least one hardware processor —~ that cooperate to acquire, process, and transform physiological waveform records into a new, clinically usable form. This is not an abstract idea, but rather a technological improvement in the way noninvasive PAP measurement is achieved.” Applicant then argues on page 8 that “While the claim involves data processing, the recited operations are inextricably tied to tangible, real-world devices that collect and transform physiological signals from a living patient. The steps are rooted in medical technology and cannot be performed in the human mind. More specifically, the claimed invention: (1) Requires physical data acquisition via specific noninvasive medical sensors placed at optimal anatomical sites; (2) Processes real-time physiological signals (waveform records) acquired from the patient; (3) transforms the acquired waveform data through specific signal conditioning (bandpass filtering), segmentation, and wavelet scattering transforms; (4) generates a new waveform (continuous PAP in mmHg) for clinical review.” Examiner notes that Applicant’s arguments avoid the crux of the abstract idea, that being the mental process, which amended claims recite the selection of collected waveform records, fragmenting the waveform based on a predefined duration, identifying learning parameters, and predicted PAP used for medical decision making. All of these steps can be done by the human mind and on paper and pencil via analysis and judgement of a human.
Applicant then argues on page 8 that “the claim integrates those elements into a practical application by: (13) requiring specific, tangible hardware (noninvasive sensors, hardware processor} (2) limiting the operations to heart failure patient monitoring, (3) producing 4 new and clinically actionable output (continuous PAP waveform in mm} that did not previously exist; (4) enabling medical decision-making based on transformed sensor data. Notably, the input signals or collected waveform records are readily obtainable through noninvasive sensors; however, they, in their original forms, do not enable practitioners to make informed medical decisions regarding heart failure patients.” 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 lastly argues on page 9 that “the claim involves a judicial exception, it contains significantly more: (1) Specific technological implementation: (a} identifies and limits to a set of defined medical sensors; (b) specifies signal filtering parameters (SO Hz bandpass suppression, 0.5 Hz low-pass cutoff), (c} uses a wavelet scattering transform with overlapping sample windows, (qd) applies a trained prediction model for continuous PAP output. (2) Concrete, physical transformation: raw physiological waveforms records have been transformed into clinically meaningful continuous PAP waveform. (3) Real-world impact: direct use in heart failure patient monitoring and clinical review. As explained above, these imitations cannot be performed generically and represent an improvement in a medical technology field.” 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 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, " 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 ". 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 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) 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, "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”. 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 usage of an artificial intelligence model in enough detail for one skilled in the art to understand how the inventor intended the function to be performed to show possession of the claimed invention. 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 in page 6 of the instant specification provides insufficient detail to the type of data that is used to train the model and the algorithm used to predict PAP waveform. 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. 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 one collected waveform from one noninvasive sensor used in the wavelet transform and AI model to generate the continuous 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) to produce the 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 one or more non-invasive sensor. Similar to Lizardtech, there is no evidence that the specification contemplated a more generic method of using one or more non-invasive sensors to generate the 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.
Claims 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the generation of the 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) to produce the PAP segment ([0072] of the PG Pub), does not reasonably provide enablement for the use of ALL of the disclosed physiological parameters must be used to generate the PAP segment and NOT one or more non-invasive sensor, as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Given the relatively incomplete understanding in using a single physiological signal to output a continuous predicted PAP waveform, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims, the claims are not enabled. See MPEP 2164.08.
The instant claims are drawn to a large genus of methods which have not been developed yet to the point where a specific benefit exists in currently available form.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112(a), the following factors enumerated In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988) are considered:
(1) the breadth of the claims,
(2) the amount of direction or guidance presented, (3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, &
(8) the quantity of experimentation necessary.
While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Breadth of the Claim
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Taking into account the factors discussed in MPEP 2164.01 (a), there is insufficient guidance and direction for one of ordinary skill in the art to use a single physiological signal to output a continuous predicted PAP waveform.
Working Examples/The Amount of Direction
The lack of predictability in the art for claims 21-27 at the time the invention was made, an undue amount of experimentation would be required to practice the claimed methods with a reasonable expectation of success. Although the instant specification discloses the enabled scope in the generation of the 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) to produce the PAP segment ([0072]), the amount of direction for any sensor signal for producing a continuous PAP waveform, would require an undue amount of experimentation would be required to practice the claimed methods with a reasonable expectation of success. The applicant has provided no direction whatsoever with regards to what within a blood glucose signal or an ECG would be used to achieve this PAP signal. Applicant has also failed to provide any direction to what within the physiological signals are used to jump from any physiological signal to a predicted continuous PAP waveform. As such, the Examiner believes the quantity of experimentation needed to make and use the invention based on the lack of content in the disclosure would be high.
Taking all of the factors into consideration leads to a conclusion that there is no enablement for the limitations discussed above. The dependent claims also lack enablement based on their association with claims 21-27.
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 how the noninvasive sensor can be disposed at more than 1 location when it is only 1 sensor.
Regarding claim 21, it is unclear how a single signal, such as ECG or blood glucose, among the selected sensors, can be used to predict a continuous PAP.
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 21-27 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 21 recites a step predict, evaluate, interpret, and report the continuous output/waveform of pulmonary artery pressure (PAP) in mmHg based on features extracted from the fragmented waveform sample windows, wherein the features are obtained through a wavelet scattering transform applied to each fragmented waveform sample window, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. processor), choosing waveform, and predicting hemodynamics parameter 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 evaluating PAP, 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 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 collected waveform records, via the processor, by requiring continuous data over a time window of 1 second…fragment the selected waveform records, via the processor, into multiple overlapping sample windows of predefined duration… identify, via the processor, learning parameters and input features, wherein the learning parameters are determined through an iterative training process… wherein 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 output in mmHg represents a transformation of the collected waveform records into a new form that is usable for patient monitoring and medical decision-making”, 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 record, fragment the windows, identifying and determining features for the model used for learning, and evaluating the predicted continuous PAP waveform for medical decision making.
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 artificial intelligence mechanism are by definition automating the human thinking process with a computer.
- “noninvasive sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “noninvasive input variable”, “physiological waveform”, “windows”, “ECG”, “PPG”, “input features”, “optimal learning parameters”, “discrete segment”, “PAP”, “RESP”, “ICG”, “PCG”, PVPW”, “PAPW”, “echocardiogram”, “blood sugar level”, “predicted continuous PAP output”, “optimize signal acquisition”, and “pressure values” 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 artificial intelligence mechanism are by definition automating the human thinking process with a computer.
- “noninvasive sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “noninvasive input variable”, “physiological waveform”, “windows”, “ECG”, “PPG”, “input features”, “optimal learning parameters”, “discrete segment”, “PAP”, “RESP”, “ICG”, “PCG”, PVPW”, “PAPW”, “echocardiogram”, “blood sugar level”, “predicted continuous PAP output”, “optimize signal acquisition”, and “pressure values” 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.
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.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796