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 Amendment
The amendment filed on January 13, 2026 was considered by the examiner. Claims 1-6, 8-11, and 15-23 are pending in the application. Claims 3 and 11 are withdrawn.
Claim Objections
Claims 2, 8, and 10 are objected to because of the following informalities:
in claim 2, line 2: “the” should be inserted before “recurring”;
in claim 8, line 4: “the” should be inserted before “recurring” (first instance); and
in claim 10, line 5: “the” should be inserted before “recurring”.
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 2 and 8-10 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.
Claim 2 recites “decomposing the respiration-compensated LAP signal” in lines 4-5, which is new matter. The specification details that the LAP signal may be decomposed, so as to identify particular frequency components, such as respiration components that are then removed to generate such a respiration-compensated LAP signal (see specification ¶[0060], ¶[0114]-[0118], ¶[0128]-[0132], ¶[0142]-[0146], and ¶[0153]-[0157]). The specification does not disclose further decomposing the respiration-compensated LAP signal. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 8 recites “ordering the recurring pressure waveforms according to temporal occurrence across successive cardiac cycles” in lines 4-5, which is new matter. The specification only describes the parsing/labeling of the signal, such as accomplished via machine learning (see specification ¶[0062]), and that the even and odd waves merely represent the A-waves and V-waves (see specification ¶[0063]). The specification does not disclose any “ordering” of recurring pressure waveforms. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 9-10 are rejected by virtue of their dependence from claim 8.
Claim 10 recites “the machine-learning model is configured to enforce alternating assignment of recurring pressure waveforms to the set of A-waves and the set of V-waves” in lines 4-5, which is new matter. The specification only describes that a machine-learning model may be utilized to identify the A and V-waves (see specification ¶[0063]). The specification does not disclose/describe enforcing alternating assignment. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
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 4 and 8-10 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.
Claim 4 recites “a time-frequency representation” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a frequency-domain representation” in claim 1, line 17. The different phraseology and indefinite article “a” suggest that they are different, but the context of the claim appears to suggest that they are the same (i.e., a frequency domain representation, obtained from the recorded time-domain LAP waveform data). If the recitations are the same, the present recitation should be “the frequency-domain representation”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, these recitations are being interpreted as the same.
Claim 8 recites “ordering the recurring pressure waveforms according to temporal occurrence across successive cardiac cycles” in lines 4-5; however, it is not clear how the recurring pressure waveforms can be ordered. The term “recurring pressure waveforms” is understood to be referring to the specific wave shapes, such as shown in Fig. 10 of the present application, in successive cardiac cycles in a LAP signal. There is no “ordering” of the waveforms, as the waveforms are already present in the LAP signal. The specification only describes the parsing/labeling of the signal, such as accomplished via machine learning (see specification ¶[0062]), and that the even and odd waves merely represent the A-waves and V-waves (see specification ¶[0063]). As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This renders claim 8 indefinite. For the purposes of examination, this recitation is being interpreted as the parsing/labeling of the A-waves and V-waves.
Claims 9-10 are rejected by virtue of their dependence from claim 8.
Claim 10 recites “the machine-learning model is configured to enforce alternating assignment of recurring pressure waveforms to the set of A-waves and the set of V-waves” in lines 4-5; however, it is not clear what “enforce alternating assignment” actually means. The specification only describes that a machine-learning model may be utilized to identify the A and V-waves (see specification ¶[0063]). The specification does not disclose or describe what enforcing alternating assignment means. As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This renders claim 10 indefinite. For the purposes of examination, this recitation is not being given patentable weight.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Eigler et al. (US Patent 11,234,702), hereinafter Eigler, in view of Ross et al. (“Clinical and hemodynamic observations in pure mitral insufficiency”, 01 July 1958 (1958-07-01), Vol. {0} 2, No. {0} 1, page 11-23 – cited by Applicant), hereinafter Ross, and in view of Baldwin et al. (“How does noise affect amplitude and latency measurement of event-related potentials (ERPs)? A methodological critique and simulation study.”, Psychophysiology, 50, 174-186, 2013 – cited in prior action), hereinafter Baldwin, and in view of Hatib et al. (US Patent Application Publication 2010/0204590), hereinafter Hatib.
Regarding Claim 17, Eigler teaches interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes (see abstract; Figs. 3-4A). Eigler teaches a cardiac monitoring system for assessment of a patient (see abstract, the shunts for monitoring and treating cardiovascular syndromes; Figs. 3-4A), comprising:
an atrial cardiac sensor configured to be implanted into a left atrium to record a left atrial pressure (LAP) signal (col. 40 ln. 62 – col. 41 ln. 60, the shunt 30 includes the leadless sensor module 34 for measuring various parameters, including LAP, col. 42 ln. 52 – col. 43 ln. 28, the leadless sensor module 34 is extended into the left atrium such that the sensing surface 32 lies within the left atrium cavity; Figs. 3-4A),
cardiac signal processing circuitry (col. 41 ln. 37 – col. 42 ln. 40, the patient display device 370, and the physician’s computer system 390, with communication between the sensor and the computers via the patient module 360, the patient module 60 is the transceiver, and either of the computers may be the cardiac signal processor; Figs. 3-4A):
a transceiver in communication with the atrial cardiac sensor and the cardiac signal processing circuitry (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, which additionally may employ a patient module 360; Figs. 3-4A),
wherein communication between the transceiver and the atrial cardiac sensor is wireless (col. 41 ln. 37 – col. 42 ln. 40, the system describes using wireless data transmission, such as via an RF transceiver modality; Fig. 3),
wherein the transceiver is configured to direct the atrial cardiac sensor to record the LAP signal (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, which additionally may employ a patient module 360, col. 57 ln. 5-35, the system may include instructions to receive the data from the sensor; Figs. 3-4A), and
wherein the transceiver is configured to be extracorporeal (col. 41 ln. 37 – col. 42 ln. 40, the computers are external, and the patient module 360 is mounted on patch 362 which is external; Fig. 3); and
a memory storing instructions that, when executed by the cardiac signal processing circuitry (col. 41 ln. 37 – col. 42 ln. 40, the patient display device 370 and/or the physician’s computer system 390, both of which contain memory, col. 57 ln. 5-35, the system may include instructions to receive the data from the sensor, instructions stored on computer readable medium; Figs. 3-4A; Fig. 3), cause the cardiac monitoring system to:
receive, via the transceiver, the recorded LAP signal sensed using the atrial cardiac sensor (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing, such that the graph of the waveform may even be viewed in real time, col 52 ln. 5-37, the graphs of the LAP signal that was received from the sensor, col. 57 ln. 5-35, the system may include instructions to receive the data from the sensor; Figs. 3-4A and 20A-21C).
Eigler does not specifically teach to calculate an A/V ratio based on a mean pressure amplitude of a set of A-waves and a mean pressure amplitude of a set of V-waves identified from the recorded LAP signal.
Ross teaches of hemodynamic findings in the left heart in patients with pure mitral insufficiency (see abstract), in which various metrics were identified, such as the V/A ratio, which exceeds 1.4 in such cases of mitral insufficiency (see pg. 15, § Left Heart Pressures and Table IV). Here, V/A ratio would be an equivalent of the A/V ratio, as the V/A ratio is merely the reciprocal of the A/V ratio.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to calculate the V/A ratio of Ross and utilize it with the monitoring and treatment of cardiovascular syndromes of Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the V/A ratio would help the medical professional caring for the patient make a determination on the patient’s care.
The modified Eigler teaches the V/A ratio, but does not specifically teach that the ratio is calculated utilizing the mean amplitude of each respective wave.
Baldwin teaches different measures, such as mean amplitude and peak amplitude, to assess event-related potentials (see abstract and pg. 177 § Bias and Efficiency ¶3), and that generally the mean amplitude is more robust to noise than the peak amplitude measure of the waveform (see abstract and pg. 180 § Discussion ¶1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the mean amplitude of the A-wave and the V-wave in the calculation of the V/A ratio instead of the peak amplitude because (1) it is the simple substitution of one known technique for another to yield predictable results and/or (2) the mean amplitude is more robust to noise than the peak amplitude measure of a waveform (see Baldwin abstract and pg. 180 § Discussion ¶1).
Eigler teaches to transmit information to a remote system (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, which additionally may employ a patient module 360; Figs. 3-4A).
The modified Eigler does not specifically teach to compare the A/V ratio to one or more threshold values; and in response to the A/V ratio exceeding the one or more threshold values, transmit information associated with the A/V ratio to the remote system to indicate a physiological condition.
Hatib teaches multivariate statistical models for the detection of vascular conditions (see abstract and Fig. 12), in which a cardiovascular parameter that is determined from atrial pressure waveform data, based off of two groups of subjects (i.e., one group experiencing a vascular condition and one group not experiencing a vascular condition), then the cardiovascular parameter is compared to a threshold value (see 320), and if the cardiovascular parameter is equal to or greater than the threshold value, the subject is determined to be experiencing the vascular condition (see ¶[0005], ¶[0058], and ¶[0067]; Fig. 12), in which the results of the comparison (i.e., indication of a vascular condition) are passed to display device 500 for presentation to and interpretation by a user (see ¶[0068]-[0069]; Fig. 12).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the threshold comparison modality of Hatib with the modified Eigler (i.e., the cardiovascular parameter (A/V ratio) is compared to a threshold and a vascular condition is indicated) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the threshold comparison provides an easy to understand output to a user (i.e., medical professional) that can be used to quickly interpret and provide appropriate care/treatment for the patient. Here, as the modified Eigler teaches the A/V ratio as required by claim 17, such a claimed threshold comparison would also work for the A/V ratio as taught by the modified Eigler.
Claims 1-2, 8-10, and 15 are rejected under 35 U.S.C. 102 as being unpatentable over Eigler in view of Ross and Baldwin, and in view of Kaiser et al. (US Patent Application Publication 2022/0304631 – cited in prior action), hereinafter Kaiser, and in view of Schulhauser et al. (US Patent Application Publication 2004/0167417), hereinafter Schulhauser.
Regarding Claim 1, Eigler teaches interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes (see abstract; Figs. 3-4A). Eigler teaches a cardiac monitoring system for remote assessment of a patient (see abstract, the shunts for monitoring and treating cardiovascular syndromes; Figs. 3-4A), comprising:
an atrial cardiac sensor configured to be implanted into a left atrium to record a left atrial pressure (LAP) signal (col. 40 ln. 62 – col. 41 ln. 60, the shunt 30 includes the leadless sensor module 34 for measuring various parameters, including LAP, col. 42 ln. 52 – col. 43 ln. 28, the leadless sensor module 34 is extended into the left atrium such that the sensing surface 32 lies within the left atrium cavity; Figs. 3-4A),
cardiac signal processing circuitry (col. 41 ln. 37 – col. 42 ln. 40, the patient display device 370, and the physician’s computer system 390, with communication between the sensor and the computers via the patient module 360, the patient module 60 is the transceiver, and either of the computers may be the cardiac signal processor; Figs. 3-4A):
a transceiver in communication with the atrial cardiac sensor and the cardiac signal processing circuitry (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, with communication between the sensor and the computers via the patient module 360, the patient module 60 is the transceiver, and either of the computers may be the cardiac signal processor; Figs. 3-4A),
wherein communication between the transceiver and the atrial cardiac sensor is wireless (col. 41 ln. 37 – col. 42 ln. 40, the system describes using wireless data transmission, such as via an RF transceiver modality; Fig. 3),
wherein the transceiver is configured to be extracorporeal (col. 41 ln. 37 – col. 42 ln. 40, the computers are external, and the patient module 360 is mounted on patch 362 which is external; Fig. 3), and
wherein the cardiac signal processing circuitry is remote from the atrial cardiac sensor (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, with communication between the sensor and the computers via the patient module 360, the patient module 60 being remote from the computers; Fig. 3); and
a memory storing instructions that, when executed by the cardiac signal process (col. 41 ln. 37 – col. 42 ln. 40, the patient display device 370 and/or the physician’s computer system 390, both of which contain memory, col. 57 ln. 5-35, the system may include instructions to receive the data from the sensor, instructions stored on computer readable medium; Figs. 3-4A; Fig. 3) to:
receive, via the transceiver, the recorded LAP signal sensed using the atrial cardiac sensor (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing, such that the graph of the waveform may even be viewed in real time, col 52 ln. 5-37, the graphs of the LAP signal that was received from the sensor, col. 57 ln. 5-35, the system may include instructions to receive the data from the sensor; Figs. 3-4A and 20A-21C),
the recorded LAP signal over a plurality of cycles (col. 47 ln. 63 – col. 48 ln. 57, a modality of use with the shunt 1500, generating a velocity profile of flow through the shunt, with an example RAP pressure trace over multiple cardiac cycles shown, of which LAP may also be generated, while shunt depicted not located inside of the left atrium, any of the shunt embodiments may be utilized, such as the aforementioned embodiment cited above; Figs. 15A-15D).
Eigler does not specifically teach to calculate an A/V ratio based on a mean pressure amplitude of a set of A-waves and a mean pressure amplitude of a set of V-waves identified from the recorded LAP signal.
Ross teaches of hemodynamic findings in the left heart in patients with pure mitral insufficiency (see abstract), in which various metrics were identified, such as the V/A ratio, which exceeds 1.4 in such cases of mitral insufficiency (see pg. 15, § Left Heart Pressures and Table IV). Here, V/A ratio would be an equivalent of the A/V ratio, as the V/A ratio is merely the reciprocal of the A/V ratio.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to calculate the V/A ratio of Ross and utilize it with the monitoring and treatment of cardiovascular syndromes of Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the V/A ratio would help the medical professional caring for the patient make a determination on the patient’s care.
The modified Eigler teaches the V/A ratio, but does not specifically teach that the ratio is calculated utilizing the mean amplitude of each respective wave.
Baldwin teaches different measures, such as mean amplitude and peak amplitude, to assess event-related potentials (see abstract and pg. 177 § Bias and Efficiency ¶3), and that generally the mean amplitude is more robust to noise than the peak amplitude measure of the waveform (see abstract and pg. 180 § Discussion ¶1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the mean amplitude of the A-wave and the V-wave in the calculation of the V/A ratio instead of the peak amplitude because (1) it is the simple substitution of one known technique for another to yield predictable results and/or (2) the mean amplitude is more robust to noise than the peak amplitude measure of a waveform (see Baldwin abstract and pg. 180 § Discussion ¶1).
The modified Eigler does not specifically teach that to remove respiration noise in the LAP signal, the cardiac monitoring system further configures the cardiac signal processor to: generate a frequency-domain representation of the recorded LAP signal; determine a respiration contribution component of the recorded LAP signal based on the frequency-domain representation of the recorded LAP signal; generate a respiration-compensated LAP signal by removing the respiration contribution component from the recorded LAP signal, the respiration- compensated LAP signal spanning a plurality of cardiac cycles.
Kaiser teaches the determination of various pressures non-invasively (see abstract), such as the A-wave and the V-wave of the left atrium (see ¶[0014]-[0015]) via machine learning (see abstract). Kaiser teaches that various sources of noise may be removed from the signals before input into the machine learning model, including noise from respiration (see ¶[0060]-[0074]), in which the noise removal may involve the removal of frequency components, and would thus involve conversions to the frequency domain, implemented via a Fast Fourier Transform (FFT) (see ¶[0072]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the noise removal (and thus the FFT) of Kaiser with the LAP signal over multiple cycles of the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) removing the noise will help get a cleaner signal for the A-wave and V-wave determination so that the patient’s condition is more accurately determined.
The modified Eigler does not specifically teach to automatically determine the A-waves and V-waves.
Kaiser further teaches that a pre-trained machine learning model may be utilized to compute the pressures and their component values (including the A-wave and V-wave) based upon the cleaned signal input into the machine learning model (see abstract and ¶[0017]-[0018], ¶[0053]-[0074] the signal is preprocessed to remove noise, ¶[0075]-[0091] the cleaned signal is segmented, ¶[0092]-[0100] features are extracted from the segmented signal, ¶[0101]-[0104] the extracted features are inputted into the pre-trained machine learning model (trained from training data) for identification of the pressures and components (including the A-wave and V-wave)).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the machine learning identification of the A-wave and V-wave of Kaiser with the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) utilizing a pre-trained machine learning model may yield more accurate determination of the A-waves and V-waves at a smaller computational cost, which would help a medical professional better make a determination on the patient’s condition.
The modified Eigler teaches that the LAP signal is recorded over and cleaned over multiple cycles, but not specifically that a multi-cycle mean amplitude A/V ratio is calculated.
Schulhauser teaches about a minimally invasive, implantable heart sound and ECG monitor, so as to derive blood pressure from the recorded data (see abstract and Fig. 4), in which a spectral analysis of the data may be performed to generate variables for calculating the blood pressure (see ¶[0022] and ¶[0063]), in which a running average for each variable is determined over a number of consecutive cardiac cycles so that various sources of noise are reduced (see ¶[0063]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the rolling average over a number of consecutive cardiac cycles of Kaiser with the variables (i.e., the mean pressure amplitude of the set of A-waves and V-waves) used to calculated the A/V ratio in the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the variables (i.e., the mean pressure amplitude of the set of A-waves and V-waves) with a rolling average over a number of consecutive cardiac cycles would reduce noise in the calculated A/V ratio from various sources (see Schulhauser ¶[0063]).
Regarding Claim 2, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. The modified Eigler further teaches wherein determining the set of A-waves and the set of V-waves automatically based on recurring pressure waveforms involves decomposing the respiration-compensated LAP signal (see Kaiser ¶[0075]-[0091] the cleaned signal is segmented, ¶[0092]-[0100] features are extracted from the segmented signal, ¶[0101]-[0104] the extracted features are inputted into the pre-trained machine learning model (trained from training data) for identification of the pressures and components (including the A-wave and V-wave); see specifically ¶[0079], the signal may be decomposed before being input into the pre-trained machine learning model).
Regarding Claim 8, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. The modified Eigler further teaches that determining the set of A-waves and the set of V-waves automatically based on recurring pressure waveforms involves ordering the recurring pressure waveforms according to temporal occurrence across successive cardiac cycles and assigning alternating ones of the ordered recurring pressure waveforms to a set of even waves and a set of odd waves (see Kaiser abstract and ¶[0017]-[0018], ¶[0053]-[0074] the signal is preprocessed to remove noise, ¶[0075]-[0091] the cleaned signal is segmented, ¶[0092]-[0100] features are extracted from the segmented signal, ¶[0101]-[0104] the extracted features are inputted into the pre-trained machine learning model (trained from training data) for identification of the pressures and components (including the A-wave and V-wave)).
Here, the specification of the present application details that the parsing of the signal may be accomplished via machine learning (see specification ¶[0062]), and that the even and odd waves merely represent the A-waves and V-waves (see specification ¶[0063]). Therefore, the determination of the A-waves and the V-waves of the modified Eigler would include the even/odd wave determination of the present claims, as the even/odd waves themselves are the A-waves and V-waves. Therefore, the recitation of the present claim is met by the modified Eigler.
Regarding Claim 9, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 8 as stated above. The modified Eigler further teaches the set of even waves and the set of odd waves are each exclusively labeled as one of the set of A- waves or the set of V-waves (see Kaiser ¶[0053]-[0074] the signal is preprocessed to remove noise, ¶[0075]-[0091] the cleaned signal is segmented, ¶[0092]-[0100] features are extracted from the segmented signal, ¶[0101]-[0104] the extracted features are inputted into the pre-trained machine learning model (trained from training data) for identification of the pressures and components (including the A-wave and V-wave)).
Regarding Claim 10, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 9 as stated above. The modified Eigler further teaches the exclusive labeling is performed using a machine learning model trained using a training data set comprising respiration-compensated LAP signals annotated with A-waves and V-waves, and wherein the machine learning model is configured to enforce alternating assignment of recurring pressure waveforms to the set of A-waves and the set of V-waves (see Kaiser ¶[0053]-[0074] the signal is preprocessed to remove noise, ¶[0075]-[0091] the cleaned signal is segmented, ¶[0092]-[0100] features are extracted from the segmented signal, ¶[0101]-[0104] the extracted features are inputted into the pre-trained machine learning model (trained from training data) for identification of the pressures and components (including the A-wave and V-wave)).
Here, as Keiser teaches the usage of a pre-trained machine learning model trained off of a training data set (see ¶[0101]-[0104]), that would necessarily include a training data set comprising cleaned LAP signals annotated with A-waves and V-waves. As the machine learning model may identify the A-waves and V-waves, the training data set would have to include annotated A-waves and V-waves; otherwise, the machine learning model would not be able to identify the A-waves and V-waves from an inputted signal. Therefore, the training data set comprising cleaned LAP signals annotated with A-waves and V-waves is inherent to the disclose of Kaiser.
Regarding Claim 15, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. Eigler further teaches the transceiver is a smart phone or a wearable device (col. 41 ln. 37 – col. 42 ln. 40, the patient module 360 is mounted on patch 362 which is external, wearable device; Fig. 3).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, and Hatib as applied to claim 17 above, and in view of Kaiser.
Regarding Claim 18, Eigler in view of Ross, Baldwin, and Hatib teaches the system of claim 17 as stated above. The modified Eigler does not specifically teach that determining the set of A-waves and the set of V-waves in the LAP signal involves decomposing the LAP signal.
Kaiser teaches the determination of various pressures non-invasively (see abstract), such as the A-wave and the V-wave of the left atrium (see ¶[0014]-[0015]) via machine learning (see abstract). Kaiser teaches that various sources of noise may be removed from the signals before input into the machine learning model, including noise from respiration (see ¶[0060]-[0074]), in which the noise removal may involve the removal of frequency components, and would thus involve conversions to the frequency domain, implemented via a Fast Fourier Transform (FFT) (see ¶[0072]). Here, the decomposition would be considered the FFT.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the noise removal (and thus the FFT) of Kaiser with the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) removing the noise will help get a cleaner signal for the A-wave and V-wave determination so that the patient’s condition is more accurately determined.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, and Hatib as applied to claim 17 above, and in view of Manolas (US Patent Application Publication 2003/0204145 – cited in prior action), hereinafter Manolas.
Regarding Claim 19, Eigler in view of Ross, Baldwin, and Hatib teaches the system of claim 17 as stated above. The modified Eigler does not specifically teach the instructions, when executed by the cardiac signal processing circuitry, further cause the cardiac monitoring system to: record a LAP signal recorded a rested state to yield a rested LAP signal; record a LAP signal during an exertion state to yield an exertion LAP signal; and compute an A/V ratio exertion response using one of: the rested LAP signal and the exertion LAP signal.
Manolas teaches a method of measuring heart function at rest and with exercise (see abstract), in which a rested pressure signal and exercise pressure signal are measured and compared to assess the measured area’s heart function (see ¶[0005]-[0015], ¶[0118]-[0126], and claims 1-5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the rest/exercise measurement and comparison with the LAP measured/determined in the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) this would further provide information on the heart function of the left atrium of the user; and/or (3) such a modality shows clear indications in LV end-diastolic and left atrial pressure (see Manolas ¶[0013]-[0014]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser as applied to claim 1 above, and in view of De Melis et al. (“Blood pressure waveform analysis by means of wavelet transform”, Med Biol Eng Comput, 47, 165-173, published online 30 September 2008 – cited in prior action), hereinafter De Melis.
Regarding Claim 4, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. The modified Eigler does not specifically teach that generating the frequency-domain representation of the recorded LAP signal involves generating a time-frequency representation of the recorded LAP signal using a wavelet analysis.
De Melis teaches about utilizing wavelet analysis to analyze the atrial pulse wave (see abstract), in which wavelet analysis may be used as opposed to Fourier transform waveform analysis on the pulse wave (see pg. 167, § Introduction, ¶4-5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the wavelet analysis of De Melis on the atrial pulse wave of the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the wavelet analysis may provide a more specific characterization of the signal’s signature (see De Melis pg. 167, § Introduction, ¶4).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser as applied to claim 1 above, and in view of Nabutovsky et al. (US Patent Application Publication 2019/0239754 – cited in prior action) hereinafter Nabutovsky.
Regarding Claim 5, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. The modified Eigler does not specifically teach that determining the respiration contribution component involves determining a respiration rate of the patient by locating a dominant frequency between 0.1 and 0.5 Hz in the frequency-domain representation of the recorded LAP signal.
Nabutovsky teaches systems, devices, and methods for determining heart rate and respiration rate based upon atrial pressure (AP) signals (see abstract), in which the LAP signal is subject to a Fourier transform to convert the signal to the frequency domain (see ¶[0043]) and then the peak (dominant) frequency is determined to be the respiration rate within the respiration rate frequency range based upon a threshold analysis, in which the respiration rate frequency range is from 9 to 39 bpm (see ¶[0020]-[0024] and ¶[0045]-[0046]). Here, the respiration rate frequency range would correspond to 0.15 Hz to 0.65 Hz.
Accordingly, it would have been obvious to one of ordinary skill the art before the effective filing date of the claimed invention to utilize the heart rate determination method of Nabutovsky with the AP signal of the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the respiration rate measure can help to provide a measure of arrhythmia which would be useful for a medical professional treating the patient to know so that the patient gets appropriate care (see Nabutovsky abstract and ¶[0020]-[0024]); and/or (3) knowing the respiration rate would enable the system to better remove the respiration rate from the signal so that an appropriate bandpass filter is applied to the signal (see Kaiser ¶[0060]-[0074]).
The respiration rate frequency range of the modified Eigler suggests the range of the present claim because 0.1 and 0.5Hz overlaps with the range of 0.15 Hz to 0.65 Hz. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 6, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. The modified Eigler does not specifically teach determining the respiration contribution component further comprises determining a heart rate of the patient by locating a dominant frequency between 0.8 Hz and 1.7 Hz in the frequency- domain representation of the recorded LAP signal.
Nabutovsky teaches systems, devices, and methods for determining heart rate and breathing rate based upon atrial pressure (AP) signals (see abstract), in which the LAP signal is subject to a Fourier transform to convert the signal to the frequency domain (see ¶[0043]) and then the peak (dominant) frequency is determined to be the heart rate within the heart rate frequency range based upon a threshold analysis, in which the heart rate frequency range is from 40 to 120 bpm (see ¶[0020]-[0024] and ¶[0045]-[0046]). Here, the heart rate frequency range would correspond to 0.67 Hz to 2 Hz.
Accordingly, it would have been obvious to one of ordinary skill the art before the effective filing date of the claimed invention to utilize the heart rate determination method of Nabutovsky with the AP signal of the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the heart rate measure can help to provide a measure of arrhythmia which would be useful for a medical professional treating the patient to know so that the patient gets appropriate care (see Nabutovsky abstract and ¶[0020]-[0024]).
The heart rate frequency range of the modified Eigler suggests the range of the present claim because 0.8Hz and 1.7 Hz falls within the range of 0.67 Hz to 2 Hz. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser as applied to claim 1 above, and in view of Manolas.
Regarding Claim 16, Eigler in view of Ross, Baldwin, Kaiser, and Schulhauser teaches the system of claim 1 as stated above. The modified Eigler does not specifically teach the instructions, when executed by the cardiac signal processing circuitry, further cause the cardiac monitoring system to: identify an A/V ratio associated with a rested state to yield a rested A/V ratio; identify an A/V ratio associated with an exertion state to yield an exertion A/V ratio; and compute an A/V ratio exertion response using: the rested A/V ratio and the exertion A/V ratio.
Manolas teaches a method of measuring heart function at rest and with exercise (see abstract), in which a rested pressure signal and exercise pressure signal are measured and compared to assess the measured area’s heart function (see ¶[0005]-[0015], ¶[0118]-[0126], and claims 1-5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the rest/exercise measurement and comparison with the LAP measured/determined in the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) this would further provide information on the heart function of the left atrium of the user; and/or (3) such a modality shows clear indications in LV end-diastolic and left atrial pressure (see Manolas ¶[0013]-[0014]). In this case, an A/V ratio determined from the rest/exercise LAP would be associated with a rest/exertion state.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, Hatib, and Manolas as applied to claim 19 above, and in view of Nearing et al. (US Patent 6,169,919 – cited in prior action), hereinafter Nearing.
Regarding Claim 20, Eigler in view of Ross, Baldwin, Hatib, and Manolas teaches the system of claim 19 as stated above. Eigler further teaches an I/O interface of the cardiac signal processing circuitry (col. 41 ln. 37 – col. 42 ln. 40, the I/O of the patient display device 370 and/or the physician’s computer system 390; Fig. 3). The modified Eigler does not specifically teach the transceiver is configured to direct the atrial cardiac sensor to record the LAP signal based on an input via the I/O interface of the cardiac signal processing circuitry.
Nearing teaches a system and method for quantifying alternation in the T-wave and ST segment in a measured ECG signal (see abstract), in which input from the user may be utilized to measure a signal (see col. 11 ln. 4-26; Fig. 10).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user initiated measurement of Nearing with the IO of the modified Eigler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) this would allow the user to start measurements, thus providing them more control over the system.
Regarding Claim 21, Eigler in view of Ross, Baldwin, Hatib, Manolas, and Nearing teaches the system of claim 20 as stated above. Eigler further teaches a hardware platform, wherein the cardiac signal processing circuitry and the transceiver are implemented in the hardware platform (col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, the embodiment without the patient module 360; Figs. 3-4A).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Eigler in view of Ross, Baldwin, Hatib, and Manolas as applied to claim 19 above, and in view of Zhang et al. (US Patent Application Publication 2023/0114833 – cited in prior action), hereinafter Zhang.
Regarding Claim 22, Eigler in view of Ross, Baldwin, Hatib, and Manolas teaches the system of claim 19 as stated above. The modified Eigler does not teach what the transceiver is implemented as, or that the transceiver is configured to direct the atrial cardiac sensor to record the LAP signal based on detection of the patient in the exertion state.
Zhang teaches methods and systems for heart rate detection via a wearable device (see abstract), in which the wearable device, monitors and when a specific state (i.e., active state or resting state) is determined, measurements may be taken (see ¶[0078]-[0082]), in which the wearable device may be implanted as a ring, a smart watch, or a smart phone (see ¶[0020]-[0022]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the specific state (i.e., active state or resting state) measurement modality of Zhang as the measurement initiator of the modified Eigler (i.e., via the patient display device 370, the mobile phone) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the automatic state detection and measurement would properly record the data in the appropriate state as directed by the medical professional and/or the method (resting vs exercise comparison) without the user needing to indicate their state to begin measurement.
Regarding Claim 23, Eigler in view of Ross, Baldwin, Hatib, Manolas, and Zhang teaches the system of claim 22 as stated above. The modified Eigler further teaches the smart phone or the wearable device comprises the cardiac signal processing circuitry and the transceiver (see Eigler col. 41 ln. 37 – col. 42 ln. 40, the communication circuitry to enable wireless transmission of data for processing and instructions to the sensors, between the leadless sensor module 34, the patient display device 370, and the physician’s computer system 390, the embodiment without the patient module 360, Figs. 3-4A; see Zhang ¶[0077]-[0078] the wearable device, such as the ring, may store and calculate values, thus necessitated computational hardware).
Response to Arguments
Applicant’s arguments, claim objection
Applicant’s arguments, see pg. 9, filed January 13, 2026, with respect to the objection of claim 17 have been fully considered and are persuasive. Therefore, the objection has been withdrawn. However, upon further consideration, a objections are made that were necessitated by Applicant’s amendment filed on January 13, 2026.
Applicant’s arguments, 35 U.S.C. § 112
Applicant’s arguments, see pg. 9, filed January 13, 2026, with respect to the rejections of claims 1-2, 5-10, and 15-23 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made under 35 U.S.C. § 112 that were necessitated by Applicant’s amendment filed on January 13, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 9-14, filed January 13, 2026, with respect to the rejections of claims 1-2, 4-10, and 15-23 under 35 U.S.C. § 103 have been fully considered; however, are moot because of the new grounds of rejection as recited above. The new grounds of rejection are made in view of Kaiser et al. (US Patent Application Publication 2022/0304631 – cited in prior action) and Schulhauser et al. (US Patent Application Publication 2004/0167417) for claim 1, and Hatib et al. (US Patent Application Publication 2010/0204590) for claim 17, that were both necessitated by Applicant’s amendment filed on January 13, 2026.
Conclusion
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hettrick et al. (US Patent Application Publication 2006/0224204) teaches an implantable medical device, in which a real-time LAP signal is utilized as feedback control mechanism for adjusting one or more device parameters via specific characteristics of the LAP signal (see abstract and Figs. 6-8), in which timing relationship ratios may be utilized in the analysis (see ¶[0029]-[0030] and Figs. 4-5).
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791