DETAILED ACTION
Applicant’s arguments, filed 04/10/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 22-51 are pending and hereby under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/10/2026 has been entered.
Claim Objections
Claims 22, 24, and 25 are objected to because of the following informalities:
Claim 22, line 7; claim 24, line 3; and claim 25, line 7, the colon should be replaced with a semicolon.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“processing unit” first recited in claim 1;
The identified structure for the corresponding claim limitation is as follows: “processing unit” is identified as “The processing of the sensor data during step 504 may be carried out, for example, to address the issue of background noise, which can originate from a variety of sources in the clinical setting and can reduce overall accuracy of pulse readings. Such background noise may result from surface-level movements of the patient's body, both direct and indirect, as well active electronic monitoring, such as electrocardiograms (ECGs), cardiac monitors, pacemaker/defibrillator pads, and ultrasounds. Background noise can lead to significant rates of false positives where a perceived pulse detection is actually interference with the patient anatomy, such as simply lifting the patient's arm. Background noise can be addressed at least in part through the choice of sensor(s) that generate the sensor data in step 504. However, in embodiments, the issue of background noise is alternatively or additionally addressed through appropriate processing of the sensor data in step 506. For example, the computer(s) that process the sensor data may filter and/or compensate for background noise to reduce such false positive readings. In the case of filtering through sensor selection, complementary sensors that are vulnerable to noise in different domains can be used together to extract the target signal. Processing of the sensor data (e.g., analog or digital signal representations) may also be performed in either or both the time and frequency domains. Strategies may include, but are not limited to, pattern matching with expected heartbeat waveforms, filtering based on key heartbeat waveform attributes (duration, amplitude, etc.), and filtering of key frequencies in the frequency domain …
Processing of the sensor data in step 506 may alternatively or additionally comprise comparing and/or combining sensor data generated by multiple different sensors of device 100 or comparing and/or combining sensor data generated by the sensor(s) of device 100 with sensor data provided from other devices that are attached to the patient. An example system that can process sensor data generated by multiple different devices that are simultaneously attached to a patient will be described below in reference to FIG. 6.
The aforementioned processing of the sensor data in step 504 can enhance the ability of device 100 or of a system including device 100 to detect a pulse condition in a patient, including a subpulse.
At step 508, a pulse condition of the patient is determined based at least on the processed sensor data. This step may be performed, for example, by any of the same computer(s) used to process the sensor data in step 506, or by a different computer that receives the processed sensor data therefrom. The determined pulse condition may include, for example and without limitation, a presence or absence of a pulse, a characteristic of a detected pulse (e.g., pulse strength), or a characteristic or condition determinable based on a detected pulse or absence thereof (e.g., heart rate, or presence of an occlusion).
At step 510, an indication of the determined pulse condition is provided (e.g., to a practitioner). For example, a visual and/or auditory indication of the determined pulse condition of the patient can be provided to a practitioner by one or more suitable user interface components of device 100, and/or by one or more suitable user interface components external to device 100” (Paragraphs 0058-0064); and
“The patient-wearable devices may thus be considered additive in nature and can be placed as desired throughout the anatomy of a patient (e.g., patient 650) to perform a specific sensing task. The ability to concurrently detect pulse conditions at different body locations may be particularly beneficial in situations of cardiac arrest and other critical conditions for which rapid pulse detection (or lack thereof) is pivotal. For example, different patient-wearable devices may be concurrently attached to the chest (possibly near the Point of Maximal Impulse (PMI)), over a carotid artery, over a femoral artery, and/or over a radial artery. Several points of contact may increase sensitivity and specificity and allow for additional clinical decisions based on data points and calculations. For example, an aortic dissection may be indicated if pulse strength readings from patient-wearable devices placed on the left side of body are different than pulse strength readings from patient-wearable devices placed on the right side of the body. Multiple points of body contact may increase accuracy and also allow real time data to be collected for oxygenation levels, body temperature, respiratory rate, and change in blood pressure” (Paragraph 0071).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 22-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 22, 32, and 42, the claims are directed towards calculating a first and second pulse strength based on first and second sensor data. However, it is unclear how the pulse strength is calculated. What sensor data is generated? How is it used to determine pulse strength? Per the claim interpretation of the processing unit above, there is no clear connection between the sensor data and the pulse strength calculation. Applicant relates blood pressure to the strength of the pulse (Paragraph 0004). As such, the claims will be interpreted such that the sensors generate data related to the pulse and a pulse strength is determined based on the pulse amplitude or a blood pressure reading. Claims 23-31, 33-41, and 43-51 are also rejected due to their dependence on claims 22, 32, and 42.
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 22-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 22, 32, and 42:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 22 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 32 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Claim 42 is directed to a non-transitory computer-program software product, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 22, 32, and 42 recite an abstract idea. In particular, the claims generally recite the following:
calculate a first pulse strength for the first body location based on the first sensor data (claims 22, 32, and 42);
calculate a second pulse strength for the second body location based on the second sensor data (claims 22, 32, and 42);
determine a difference between the first pulse strength and the second pulse strength (claims 22, 32, and 42); and
detect the presence of a vascular occlusion in the body of the patient based on at least the difference between the first pulse strength and the second pulse strength (claims 22, 32, and 42)
These elements recited in claims 22, 32, and 42 are drawn to an abstract idea since they are directed towards mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“calculate a first pulse strength for the first body location based on the first sensor data” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review sensor data to determine a pulse strength. There is nothing to suggest an undue level of complexity in “calculate a first pulse strength for the first body location based on the first sensor data”.
“calculate a second pulse strength for the first body location based on the second sensor data” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review sensor data to determine a pulse strength. There is nothing to suggest an undue level of complexity in “calculate a second pulse strength for the first body location based on the second sensor data”.
“determine a difference between the first pulse strength and the second pulse strength” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably measure or calculate a different between two pulse strength measurements. There is nothing to suggest an undue level of complexity in “determine a difference between the first pulse strength and the second pulse strength”.
“detect the presence of a vascular occlusion in the body of the patient based on at least the difference between the first pulse strength and the second pulse strength” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review a different between two pulse strength measurements to determine a presence of a vascular occlusion. There is nothing to suggest an undue level of complexity in “detect the presence of a vascular occlusion in the body of the patient based on at least the difference between the first pulse strength and the second pulse strength”.
Prong Two: Claims 22, 32, and 42 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "a first patient-wearable device that is attachable to a first body location of a patient and that comprises one or more first sensors that are configured to generate first sensor data" (claim 22), "a second patient-wearable device that is attachable to a second body location of the patient and that comprises one or more second sensors that are configured to generate second sensor data" (claim 22), “receive from the first patient-wearable device the first sensor data” (claims 22, 32, and 42), “receive from the second patient-wearable device the second sensor data” (claims 22, 32, and 42), “establishing communication with a first patient-wearable device that is attached to a first body location of a patient and that comprises one or more first sensors that are configured to generate first sensor data” (claims 32 and 42), and “establishing communication with a second patient-wearable device that is attached to a second body location of the patient and that comprises one or more second sensors that are configured to generate second sensor data” (claims 32 and 42))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 22, 32, and 42 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a patient-wearable device” as disclosed in the Applicant’s specification paragraph 0074, “the patient-wearable devices all possess the same type of sensor and thus generate the same type of sensor data. However, in an alternate embodiment, the patient-wearable devices possess different types of sensors and thus generate different types of sensor data. For example, some of the patient-wearable devices shown in FIG. 6 may include an IMU but not an acoustic sensor, while other ones of the patient-wearable devices shown in FIG. 6 may include an acoustic sensor but not an IMU. Furthermore, some of the patient-wearable devices shown in FIG. 6 may include sensors for detecting qualities of the patient other than the presence of a pulse (e.g., blood pressure, blood sugar, blood oxygen, echocardiogram, body temperature, respiratory rate, blood flow rate), while other ones of the patient-wearable devices shown in FIG. 6 may not include such sensors. In further accordance with such embodiments, each patient-wearable device may include an identifier of the type of sensor used to generate the sensor data when transmitting the sensor data to computing device 628”.
A “processing unit” as disclosed in Applicant’s specification in paragraph 0069, “Processing unit 634 may comprise one or more microprocessors, microcontrollers, DSPs, and/or ASICs.” These elements do not qualify as significantly more because this limitation is simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements include a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 23-31, 33-41, and 43-51 depend from the independent claims. Dependent claims 23-31, 33-41, and 43-51 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“wherein at least one of: the first pulse strength is indicative of a first subpulse; or the second pulse strength is indicative of a second subpulse” (claims 23, 33, and 43), “filter the first sensor data in one or more of the time domain and the frequency domain to calculate the first pulse strength; and filter the second sensor data in one or more of the time domain and the frequency domain to calculate the second pulse strength” (claims 27, 37, and 47)),
Further describe the pre-solution activity (“wherein: the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) and a first acoustic sensor: and the one or more second sensors comprise one or more of a second IMU and a second acoustic sensor” (claims 24, 34, and 44), “wherein: the first body location comprises a location on the chest of the patient; and the second body location comprises one of: a location over a carotid artery of the patient; a location over a femoral artery of the patient; a location over a radial artery of the patient; a location over a dorsalis pedis artery of the patient: a location over a posterior tibial artery of the patient; or a location over a popliteal artery of the patient” (claims 25, 35, and 45), “wherein the first body location and the second body location are different locations selected from the group consisting of neck, chest, arm, wrist, groin, ankle and foot” (claims 26, 36, and 46), “wherein the first patient-wearable device is communicatively connected to the second patient-wearable device and wherein the processing unit is communicatively connected to the second patient-wearable device via the first patient-wearable device” (claims 28, 38, and 48), “wherein the processing unit comprises part of a computing device that is separate from and communicatively connected to the first patient-wearable device and the second patient-wearable device” (claims 29, 39, and 49), “wherein the processing unit comprises part of the first patient-wearable device” (claims 30, 40, and 50), and “wherein: the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device” (claims 31, 41, and 51)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the processing unit and/or system to perform different. The result of the abstract idea does not cause output of the vascular occlusion. The result of the abstract idea does not direct or cause a computer to perform an action based on the output of the vascular occlusion.
Therefore, claims 22-51 are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-27, 30-37, 40-47, and 50-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kline (US 20190125196).
Regarding claim 22, Kline teaches a system, comprising:
a first patient-wearable device that is attachable to a first body location of a patient (see Fig. 11 below) and that comprises one or more first sensors (Paragraph 0189, disposable sensor pad 18) that are configured to generate first sensor data (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Paragraph 0188, placed against the skin to listen to the underlying circulatory system);
a second patient-wearable device that is attachable to a second body location of the patient (see Fig. 11 below) and that comprises one or more second sensors (Paragraph 0189, disposable sensor pad 18) that are configured to generate second sensor data (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Paragraph 0188, placed against the skin to listen to the underlying circulatory system); and
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a processing unit that is communicatively connected to the first patient-wearable device and the second patient-wearable device (Fig. 18, PCB processor board 110 with processing unit 112), wherein the processing unit is configured to:
receive from the first patient-wearable device the first sensor data (Paragraph 0247, wherein the piezoelectric sensors detect the audio and transmit to the processing unit);
calculate a first pulse strength for the first body location based on the first sensor data (Paragraphs 0312 and 0326, calculating power spectral density; Paragraph 0314, wherein the power is equated to the square of the amplitude; Examiner matches the amplitude from the sound signal to the pulse strength);
receive from the second patient-wearable device the second sensor data (Paragraph 0247, wherein the piezoelectric sensors detect the audio and transmit to the processing unit);
calculate a second pulse strength for the second body location based on the second sensor data (Paragraphs 0312 and 0326, calculating power spectral density; Paragraph 0314, wherein the power is equated to the square of the amplitude; Examiner matches the amplitude from the sound signal to the pulse strength);
determine a difference between the first pulse strength and the second pulse strength (Paragraphs 0329-0332 and Fig. 38, wherein the data is collected between the sensors, the power spectral density is generated, and spikes differences are compared between the signals to determine a stenosis); and
detect the presence of a vascular occlusion (Paragraph 0299, “the data is processed 346 to calculate occlusion or stenosis of the artery being reviewed”; Paragraph 0305, “This setup will allow for detection of stenosis along a linear path and determining of position of an occlusion between the two piezo sensors”) in the body of the patient based on at least the difference between the first pulse strength and the second pulse strength (Paragraphs 0329-0332 and Fig. 38, wherein the data is collected between the sensors, the power spectral density is generated, and spikes differences are compared between the signals to determine a stenosis).
Regarding claim 23, Kline further teaches wherein at least one of:
the first pulse strength is indicative of a first subpulse; or the second pulse strength is indicative of a second subpulse (Paragraph 0332, “If f1 is not present, the artery is too stenosed to show a base ring vortex and therefore we conclude there is a very high level of stenosis … If neither f1 nor f2 are present, the patient is stenosed to the point where ring vortices can no longer form. This patient has extremely high stenosis and needs to see a specialist as soon as possible”; Examiner interprets such detection of sounds without the peaks depicting a base ring vortex or other ring vortices to be a “subpulse”).
Regarding claim 24, Kline further teaches wherein:
the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) and a first acoustic sensor (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Fig. 7, piezos 90); and
the one or more second sensors comprise one or more of a second IMU and a second acoustic sensor (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Fig. 7, piezos 90).
Regarding claim 25, Kline further teaches wherein:
the first body location comprises a location on the chest of the patient (Paragraph 0258 and Fig. 11, one sensor placed over the chest adjacent to the heart); and
the second body location comprises one of: a location over a carotid artery of the patient (Paragraph 0258 and Fig. 11, one sensor placed over the carotid artery).
Regarding claim 26, Kline further teaches wherein the first body location and the second body location are different locations selected from the group consisting of neck, chest, arm, wrist, groin, ankle and foot (Fig. 11, one sensor at the chest and the other sensor at the neck).
Regarding claim 27, Kline further teaches wherein the processing unit is further configured to:
filter the first sensor data in one or more of the time domain and the frequency domain to calculate the first pulse strength; and filter the second sensor data in one or more of the time domain and the frequency domain to calculate the second pulse strength (Paragraphs 0329-0332, wherein the data is de-noised to remove low frequency components before generating a power spectral density of the sound data from the piezo sensors).
Regarding claim 30, Kline further teaches wherein the processing unit comprises part of the first patient-wearable device (Fig. 7, wherein the chest sensor with piezo 90 includes PCB 110 in PCB housing 115).
Regarding claim 31, Kline further teaches wherein:
the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device (Paragraph 0260, wherein the each sensor pod communicates with the computer. Each sensor pod will predict a certain sound and if the sound does not match, the sensor that is not detecting the proper sound will be identified and an alert will be sent to adjust the position of the sensor. Examiner interprets this step such that the computer can determine which sensor pod is which based on the predicted sound, the predicted sound being the identifier).
Regarding claim 32, Kline teaches a method performed by a processing unit, comprising
establishing communication with a first patient-wearable device that is attachable to a first body location of a patient (see Fig. 11 below) and that comprises one or more first sensors (Paragraph 0189, disposable sensor pad 18) that are configured to generate first sensor data (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Paragraph 0188, placed against the skin to listen to the underlying circulatory system);
establishing communication with a second patient-wearable device that is attachable to a second body location of the patient (see Fig. 11 below) and that comprises one or more second sensors (Paragraph 0189, disposable sensor pad 18) that are configured to generate second sensor data (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Paragraph 0188, placed against the skin to listen to the underlying circulatory system); and
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receiving from the first patient-wearable device the first sensor data (Paragraph 0247, wherein the piezoelectric sensors detect the audio and transmit to the processing unit);
calculating a first pulse strength for the first body location based on the first sensor data (Paragraphs 0312 and 0326, calculating power spectral density; Paragraph 0314, wherein the power is equated to the square of the amplitude; Examiner matches the amplitude from the sound signal to the pulse strength);
receiving from the second patient-wearable device the second sensor data (Paragraph 0247, wherein the piezoelectric sensors detect the audio and transmit to the processing unit);
calculating a second pulse strength for the second body location based on the second sensor data (Paragraphs 0312 and 0326, calculating power spectral density; Paragraph 0314, wherein the power is equated to the square of the amplitude; Examiner matches the amplitude from the sound signal to the pulse strength);
determining a difference between the first pulse strength and the second pulse strength (Paragraphs 0329-0332 and Fig. 38, wherein the data is collected between the sensors, the power spectral density is generated, and spikes differences are compared between the signals to determine a stenosis); and
detecting the presence of a vascular occlusion (Paragraph 0299, “the data is processed 346 to calculate occlusion or stenosis of the artery being reviewed”; Paragraph 0305, “This setup will allow for detection of stenosis along a linear path and determining of position of an occlusion between the two piezo sensors”) in the body of the patient based on at least the difference between the first pulse strength and the second pulse strength (Paragraphs 0329-0332 and Fig. 38, wherein the data is collected between the sensors, the power spectral density is generated, and spikes differences are compared between the signals to determine a stenosis).
Regarding claim 33, Kline further teaches wherein at least one of:
the first pulse strength is indicative of a first subpulse; or the second pulse strength is indicative of a second subpulse (Paragraph 0332, “If f1 is not present, the artery is too stenosed to show a base ring vortex and therefore we conclude there is a very high level of stenosis … If neither f1 nor f2 are present, the patient is stenosed to the point where ring vortices can no longer form. This patient has extremely high stenosis and needs to see a specialist as soon as possible”; Examiner interprets such detection of sounds without the peaks depicting a base ring vortex or other ring vortices to be a “subpulse”).
Regarding claim 34, Kline further teaches wherein:
the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) and a first acoustic sensor (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Fig. 7, piezos 90); and
the one or more second sensors comprise one or more of a second IMU and a second acoustic sensor (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Fig. 7, piezos 90).
Regarding claim 35, Kline further teaches wherein:
the first body location comprises a location on the chest of the patient (Paragraph 0258 and Fig. 11, one sensor placed over the chest adjacent to the heart); and
the second body location comprises one of: a location over a carotid artery of the patient (Paragraph 0258 and Fig. 11, one sensor placed over the carotid artery).
Regarding claim 36, Kline further teaches wherein the first body location and the second body location are different locations selected from the group consisting of neck, chest, arm, wrist, groin, ankle and foot (Fig. 11, one sensor at the chest and the other sensor at the neck).
Regarding claim 37, Kline further teaches wherein the processing unit is further configured to:
filter the first sensor data in one or more of the time domain and the frequency domain to calculate the first pulse strength; and filter the second sensor data in one or more of the time domain and the frequency domain to calculate the second pulse strength (Paragraphs 0329-0332, wherein the data is de-noised to remove low frequency components before generating a power spectral density of the sound data from the piezo sensors).
Regarding claim 40, Kline further teaches wherein the processing unit comprises part of the first patient-wearable device (Fig. 7, wherein the chest sensor with piezo 90 includes PCB 110 in PCB housing 115).
Regarding claim 41, Kline further teaches wherein:
the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device (Paragraph 0260, wherein the each sensor pod communicates with the computer. Each sensor pod will predict a certain sound and if the sound does not match, the sensor that is not detecting the proper sound will be identified and an alert will be sent to adjust the position of the sensor. Examiner interprets this step such that the computer can determine which sensor pod is which based on the predicted sound, the predicted sound being the identifier).
Regarding claim 42, Kline teaches a method performed by a processing unit, comprising:
establishing communication with a first patient-wearable device that is attachable to a first body location of a patient (see Fig. 11 below) and that comprises one or more first sensors (Paragraph 0189, disposable sensor pad 18) that are configured to generate first sensor data (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Paragraph 0188, placed against the skin to listen to the underlying circulatory system);
establishing communication with a second patient-wearable device that is attachable to a second body location of the patient (see Fig. 11 below) and that comprises one or more second sensors (Paragraph 0189, disposable sensor pad 18) that are configured to generate second sensor data (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Paragraph 0188, placed against the skin to listen to the underlying circulatory system); and
[AltContent: textbox (Second patient-wearable device)][AltContent: arrow][AltContent: textbox (First patient-wearable device)][AltContent: arrow]
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receiving from the first patient-wearable device the first sensor data (Paragraph 0247, wherein the piezoelectric sensors detect the audio and transmit to the processing unit);
calculating a first pulse strength for the first body location based on the first sensor data (Paragraphs 0312 and 0326, calculating power spectral density; Paragraph 0314, wherein the power is equated to the square of the amplitude; Examiner matches the amplitude from the sound signal to the pulse strength);
receiving from the second patient-wearable device the second sensor data (Paragraph 0247, wherein the piezoelectric sensors detect the audio and transmit to the processing unit);
calculating a second pulse strength for the second body location based on the second sensor data (Paragraphs 0312 and 0326, calculating power spectral density; Paragraph 0314, wherein the power is equated to the square of the amplitude; Examiner matches the amplitude from the sound signal to the pulse strength);
determining a difference between the first pulse strength and the second pulse strength (Paragraphs 0329-0332 and Fig. 38, wherein the data is collected between the sensors, the power spectral density is generated, and spikes differences are compared between the signals to determine a stenosis); and
detecting the presence of a vascular occlusion (Paragraph 0299, “the data is processed 346 to calculate occlusion or stenosis of the artery being reviewed”; Paragraph 0305, “This setup will allow for detection of stenosis along a linear path and determining of position of an occlusion between the two piezo sensors”) in the body of the patient based on at least the difference between the first pulse strength and the second pulse strength (Paragraphs 0329-0332 and Fig. 38, wherein the data is collected between the sensors, the power spectral density is generated, and spikes differences are compared between the signals to determine a stenosis).
Regarding claim 43, Kline further teaches wherein at least one of:
the first pulse strength is indicative of a first subpulse; or the second pulse strength is indicative of a second subpulse (Paragraph 0332, “If f1 is not present, the artery is too stenosed to show a base ring vortex and therefore we conclude there is a very high level of stenosis … If neither f1 nor f2 are present, the patient is stenosed to the point where ring vortices can no longer form. This patient has extremely high stenosis and needs to see a specialist as soon as possible”; Examiner interprets such detection of sounds without the peaks depicting a base ring vortex or other ring vortices to be a “subpulse”).
Regarding claim 44, Kline further teaches wherein:
the one or more first sensors comprise one or more of a first inertial measurement unit (IMU) and a first acoustic sensor (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Fig. 7, piezos 90); and
the one or more second sensors comprise one or more of a second IMU and a second acoustic sensor (Paragraph 0181, piezoelectric sensors utilized as a contact microphone; Fig. 7, piezos 90).
Regarding claim 45, Kline further teaches wherein:
the first body location comprises a location on the chest of the patient (Paragraph 0258 and Fig. 11, one sensor placed over the chest adjacent to the heart); and
the second body location comprises one of: a location over a carotid artery of the patient (Paragraph 0258 and Fig. 11, one sensor placed over the carotid artery).
Regarding claim 46, Kline further teaches wherein the first body location and the second body location are different locations selected from the group consisting of neck, chest, arm, wrist, groin, ankle and foot (Fig. 11, one sensor at the chest and the other sensor at the neck).
Regarding claim 47, Kline further teaches wherein the processing unit is further configured to:
filter the first sensor data in one or more of the time domain and the frequency domain to calculate the first pulse strength; and filter the second sensor data in one or more of the time domain and the frequency domain to calculate the second pulse strength (Paragraphs 0329-0332, wherein the data is de-noised to remove low frequency components before generating a power spectral density of the sound data from the piezo sensors).
Regarding claim 50, Kline further teaches wherein the processing unit comprises part of the first patient-wearable device (Fig. 7, wherein the chest sensor with piezo 90 includes PCB 110 in PCB housing 115).
Regarding claim 51, Kline further teaches wherein:
the first sensor data received from the first patient-wearable device includes an identifier of the first patient-wearable device; and the second sensor data received from the second patient-wearable device includes an identifier of the second patient-wearable device (Paragraph 0260, wherein the each sensor pod communicates with the computer. Each sensor pod will predict a certain sound and if the sound does not match, the sensor that is not detecting the proper sound will be identified and an alert will be sent to adjust the position of the sensor. Examiner interprets this step such that the computer can determine which sensor pod is which based on the predicted sound, the predicted sound being the identifier).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28, 38, and 48 under 35 U.S.C. 103 as being unpatentable over Kline (US 20190125196) as applied to claims 22, 32, and 42 above, and further in view of Raj (US 20190314192).
Regarding claims 28, 38, and 48, Kline discloses the system and method of claims 22, 32, and 42 as described above. Kline fails to explicitly disclose wherein the first patient-wearable device is communicatively connected to the second patient-wearable device and wherein the processing unit is communicatively connected to the second patient-wearable device via the first patient-wearable device.
Raj teaches a respiratory monitoring system (Abstract) that includes using acoustic sensors for measuring biometric signals on the body (Paragraph 0040). Raj teaches an arrangement of sensors wherein one wearable device communicates between the processor and the other sensors worn on the body (Paragraph 0030). As there are a limited number of predictable ways to arrange the worn sensors and how they communicate with the processor, one of ordinary skill has good reason to pursue the known options within his or her technical grasp. By limiting one sensor to communicate between the processor and other sensors, the device has a whole would require less processing power implemented thereon. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kline to incorporate the sensor communication arrangement as taught by Raj to reduce the number of processors required in the device.
Claims 29, 39, and 49 under 35 U.S.C. 103 as being unpatentable over Kline (US 20190125196) as applied to claims 22, 32, and 42 above, and further in view of Kline (US 20190125196).
Regarding claims 29, 39, and 49, Kline discloses the system and method of claims 22, 32, and 42 as described above. Kline fails to explicitly disclose wherein the processing unit comprises a part of a computing device that is separate from and communicatively connected to the first patient-wearable device and the second patient-wearable device in one embodiment.
However, Kline discloses an embodiment of the system wherein the method is performed on a computer connected to the array and/or sensor pods wirelessly (Paragraph 0077). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kline to be performed on a separate computer as taught by Kline in another embodiment, the benefit being reducing the processing power required by the sensors/array.
Response to Arguments
Applicant's arguments filed 12/05/2025, with respect to the 35 U.S.C. §101 rejections have been fully considered and are persuasive. Applicant has amended the claims to recite a non-transitory computer readable medium. The rejection of the claims has been withdrawn. However, upon further consideration of the claims, a new 35 U.S.C. §101 rejection has been applied as described above.
Applicant’s arguments, see page 10, filed 12/05/2025, with respect to the rejection(s) of claim(s) 22-51 under 35 U.S.C. §103 have been fully considered and are persuasive. The Examiner agrees with the Applicant’s argument that the combination of Raj and Sandler do not teach detecting pulse strengths at two locations and taking the difference between the pulse strength measurements to determine a stenosis. Therefore, the rejection of the claims has been withdrawn. However, a new ground(s) of rejection is made in view of Kline as described above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Allen (“Photoplethysmography detection of lower limb peripheral arterial occlusive disease: a comparison of pulse timing, amplitude and shape characteristics”) teaches detecting an occlusion in the legs using multi-site PPG analysis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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