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 .
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 19 follows.
STEP 1
Regarding Claim 19, the claim recites a series of steps or acts, including using a strain sensor, collecting signals indicative of strain response at a peripheral arterial region of the subject; using a photoplethysmogram sensor, collecting signals indicative of a blood volume and/or blood circulation changes at the peripheral arterial region; determining, in the processor, a first line fit profile; determining, in the processor, a second line fit profile; determining, in the processor, external cuff pressure affected line fit features; and determining a blood pressure and/or a systemic vascular resistance for the peripheral arterial region. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps determining a blood pressure and/or a systemic vascular resistance for the peripheral arterial region set forth a judicial exception. These steps describe a concept performed by mathematical calculations. Thus, the claim is drawn to a Mathematical Concept, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 19 fails to recite any application of determining a blood pressure and/or a systemic vascular resistance for the peripheral arterial region that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on determining a blood pressure and/or a systemic vascular resistance for the peripheral arterial region, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 19 recites additional steps of collecting signals indicative of strain response at a peripheral arterial region; collecting signals indicative of a blood volume and/or blood circulation changes at the peripheral arterial region; determining a first line fit profile; determining a second line fit profile; and determining external cuff pressure affected line fit features. The collecting and determining steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the collecting and determining steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding Claim 1, the claim recites a series of components, including a device comprising a strain sensor, a photoplethysmogram sensor, a support structure, and a processor configured to collect signals indicative of the strain response and the signals indicative of the blood volume and/or blood circulation changes; determine a first line fit profile; determine a second line fit profile; determine external cuff pressure affected line fit features; and determine a blood pressure and/or systemic vascular resistance for the peripheral arterial region. Thus, the claim is directed to a machine, which is one of the statutory categories of invention. The function of determining a blood pressure and/or a systemic vascular resistance for the peripheral arterial region sets forth a judicial exception. This function describes a concept performed by mathematical calculations. Thus, the claim is drawn to a Mathematical Concept, which is an Abstract Idea. Additionally, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited “processor” is a generic device configured to perform “collecting signals”, “determining line fit profiles”, “determining external cuff pressure affected line fit features” as well as perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Dependent Claims 2-18 and 20-29 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing. A “processor” is recited at a high level of generality that they amount to a generic computer and generic computer program. The step of estimating an output is mere pre-solution data gathering. Regarding Claims 9 and 10, the formulas are mathematical concepts that do not overcome the judicial exception and/or abstract idea as mathematical concepts are themselves drawn to an abstract idea.
The collecting and determining steps recited in the independent claims, Claims 1-29, maintain a high level of generality even when considered in combination with the dependent claims.
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 1-2, 4, 8-9, 11-17, 19-20, 22, and 26-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ward et. al.'221 (U.S. Patent Publication 20200054221 - cited by applicant).
Regarding Claim 1, Ward et. al.’221 discloses a device for non-invasively measuring one or more hemodynamic variables of a subject, the device comprising: a strain sensor positioned in the device to generate signals indicative of strain response at a peripheral arterial region of the subject (Paragraph [0130] - The piezoelectric sensor 1902 responds predominantly to tangential stress or strain in the PVDF sensor of a wearable device, as the PVDF sensor stretches in response to fluctuations in pressure and volume inside the underlying arteries);
a photoplethysmogram sensor positioned in the device to generate signals indicative of a blood volume and/or blood circulation changes at the peripheral arterial region (Paragraph [0065] - a secondary sensor for collecting photoplethysmography derived blood flow data);
a support structure physically coupled to the strain sensor and the photoplethysmogram sensor to physically support the device at the peripheral arterial region (Paragraph [0064] - the wearable sensor 816 may include both a piezoelectric pressure sensor for measuring raw signal pressure data and a secondary sensor for collecting photoplethysmography derived blood flow and hemoglobin oxygen saturation data); and
a processor in communication with the strain sensor and the photoplethysmogram sensor (Paragraph [0062] - For example, the data may be data gathered by the wearable sensor 816, data determined and/or calculated by the processor 808; Paragraph [0085] - In reference to FIG. 5, at blocks 402 and 404 raw signal data from piezoelectric sensor 200 and a raw signal data from secondary sensor are provided to the signal processor system 300) and configured to:
collect the signals indicative of the strain response and the signals indicative of the blood volume and/or blood circulation changes during changes in an externally applied cuff pressure to the subject (Paragraph [0104] - In the example scenario, both the piezoelectric and pulse-oximetry signals are collected from a patient while the subject performed some specified breathing exercises/maneuvers…The breathing maneuvers performed by the individual, whose data is depicted in FIGS. 9 and 10 may include, by way of example… BP cuff inflation and deflation—where a BP cuff is attached to the he subject's upper arm to which the other sensors are connected);
determine a first line fit profile of the signals indicative of the strain response versus externally applied cuff pressure (Paragraph [0101] - FIGS. 9, 10, 11, and 12 illustrate an example scenario in which data is gathered from a sensor assembly with both piezoelectric and pulse-oximetry sensors. Signals from both sensors may be received from the same sensor assembly (e.g., on a finger) while a patient performs several physiologic maneuvers);
determine a second line fit profile of the signals indicative of the blood volume and/or blood circulation changes versus externally applied cuff pressure (Paragraph [0101] - FIGS. 9, 10, 11, and 12 illustrate an example scenario in which data is gathered from a sensor assembly with both piezoelectric and pulse-oximetry sensors. Signals from both sensors may be received from the same sensor assembly (e.g., on a finger) while a patient performs several physiologic maneuvers; see Annotated Figure 13G below); and
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Annotated Figure 13G
determine external cuff pressure affected line fit features from the first line fit and from the second line fit and from the external cuff pressure affected line fit features, and determine a blood pressure and/or a systemic vascular resistance for the peripheral arterial region, as the one or more hemodynamic variables (Paragraph [0096] - extract feature indicators of circulating vascular volume and vascular tone. These features include, as described in examples below, vascular resistance).
Regarding Claim 2, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the processor is configured to: determine the first line fit profile of the signals indicative of the strain response versus externally applied cuff pressure using a linear regression (Paragraph [0140] - At the process 1902, PPG sensor data and PVDF sensor data are compared and quantified through linear regression of a resulting PPG/PVDF hysteresis loop, e.g., taken over a number of cardiac cycles; see Annotated Figure 10 below).
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Annotated Figure 10
Regarding Claim 4, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the processor is configured to: determine the second line fit profile of the signals indicative of the blood volume and/or blood circulation changes versus externally applied cuff pressure using a linear regression (Paragraph [0140] - At the process 1902, PPG sensor data and PVDF sensor data are compared and quantified through linear regression of a resulting PPG/PVDF hysteresis loop, e.g., taken over a number of cardiac cycles; see Annotated Figure 10 above).
Regarding Claim 8, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as wherein the external cuff pressure affected line fit features comprise one or more features selected from: [table] (Paragraph [0098] - the signal-processing device 904 may be configured to identify local peaks in the received data from the sensor (including peak data for each different sensor type within the sensor) and from a difference in peak values determine a vascular volume and/or vascular tone; Paragraph [0108] - The output of the piezoelectric sensor may be linearly dependent on pressure, but the linear coefficient may vary based on location of a sensor assembly and tightness of fit. As such, physiological details may be inferred from relative height of features in the output signal and variation in the signal over time, not by absolute voltage output; refer to Figure 10).
Regarding Claim 9, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the processor is configured to determine the blood pressure and/or the systemic vascular resistance for the peripheral arterial region using a 2D model of the peripheral arterial region, the 2D model comprising an expression for pressure as a function of longitudinal length and cross-sectional radius inside the peripheral arterial region (Paragraph [0123] - As a result, we developed a model for determining vascular resistance based on measurements from the pulse-oximetry sensor…The volume, V.sub.i, can alternatively be related to the inner radius of the artery r.sub.i and length of artery illuminated by the PPG, L.sub.PPG. The length of the artery under the PPG sensor 1904 is assumed constant).
Regarding Claim 11, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the strain sensor is a piezoelectric sensor (Paragraph [0130] - The piezoelectric sensor 1902 responds predominantly to tangential stress or strain).
Regarding Claim 12, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the strain sensor is a polyvinylidene fluoride sensor (Paragraph [0130] - strain in the PVDF sensor of a wearable device, as the PVDF sensor stretches in response to fluctuations in pressure and volume inside the underlying arteries).
Regarding Claim 13, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the processor is further configured to determine components of the systemic vascular resistance (Paragraph [0121] - The sensor devices herein may be implemented to determine vascular radius and systemic vascular resistance through the use of a vascular resistance controller that analyzes sensor data using developed vascular resistance models).
Regarding Claim 14, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the strain sensor is selected from the group consisting of: an optical sensor, a force based sensor, an electrical based sensor, and an ultrasonic sensor (Paragraph [0130] - The piezoelectric sensor 1902 responds predominantly to tangential stress or strain).
Regarding Claim 15, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the support structure is a band (Paragraph [0118] - FIG. 16B illustrates the sensor 1600 in a wearable device 1610, having an attachment band 1612 for affixing to a subject).
Regarding Claim 16, Ward et. al.’221 discloses the device outlined in Claim 15 above as well as the band is configured to attach to a finger of the subject (Paragraph [0118] - the sensor 1600 in a wearable device 1610, having an attachment band 1612 for affixing to a subject, such as for affixing to a finger)
Regarding Claim 17, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as the strain sensor is configured to sense a strain from a body part selected from the group consisting of: a finger, a wrist, an arm, a thigh, a calf, an ankle, a toe, a temple, a nose, a chest, and a neck (Paragraph [0113] - A support structure component 1412, such as a structure or band constructed as a polymer laminate (including, for example, a PVDF laminate), may support the piezoelectric sensors 1402 and the pulse-oximetry sensor components 1404 and 1408 such that they are positioned to gather vascular wall motion and blood flow dependent measurements. For example, as illustrated in FIG. 14B, the two device sensor 1400 may attach to a finger of a patient).
Regarding Claim 19, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 1 disclose a method set forth in the claim.
Regarding Claim 20, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 2 disclose a method set forth in the claim.
Regarding Claim 22, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 4 disclose a method set forth in the claim.
Regarding Claim 26, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 8 disclose a method set forth in the claim.
Regarding Claim 27, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 9 disclose a method set forth in the claim.
Regarding Claim 28, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 11 disclose a method set forth in the claim.
Regarding Claim 29, the sections of Ward et. al.’221 cited above in the rejection breakdown of Claim 12 disclose a method set forth in the claim.
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.
Claims 3, 5, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al.'221 (U.S. Patent Publication 20200054221 - cited by applicant) as applied to Claim 1 above, and further in view of Lading et. al.'095 (U.S. Patent Publication 20150238095 – previously cited).
Regarding Claim 3, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as comparing data from piezoelectric sensors to past data (Paragraph [0097] - The signal-processing device 904 is configured to automatically analyze the wearable sensor data and compare that data to recently-recorded or historically-recorded data to allow for more accurate analysis of the signal data; Paragraph [0140] - During each cardiac cycle a comparison ellipse is generated, by the process 1920, for the best least squares fit of the hysteresis loop between the PPG sensor and the piezoelectric sensor outputs for both the measured (experimental) data and the projected (hypothetical fixed radius) data, as shown in FIG. 24). Ward et. al.’221 fails to disclose determining the first line fit profile of the signals indicative of the strain response versus externally applied cuff pressure using a best fit optimization against a predetermined baseline fit profile. Lading et. al.'095 teaches analyzing stress-strain data comprising externally applied pressure by utilizing best fit methods against baseline values (Paragraph [0081] - the control unit may select a model from a set of models. The selection of a model may be based on best fit or other considerations. For example, fitting procedures may be used for the selection of the model, which may include a simple least squaring fitting or fitting including weights to values proportional to the corresponding applied external counter pressures. In addition, other techniques for fitting may be used such as least squares, weighted least squares (e.g., a fitting where the weighting is proportional to the counter pressure), iterative proportional fitting, matrix ranking, regression analysis, or differential or partial differential equation solutions. The model may be selected from a predetermined stress-strain relationship of the artery, a Bramwell-Hill equation, an exponential model, a bi-linear model, and/or others). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ward et. al.’221 to include comparing measurement data obtained during externally applied pressure to predetermined baseline data in order to account for elastic properties of an artery changing over time as seen in Lading et. al.’095 (Paragraph [0058] - The elastic properties of the arterial wall may be highly non-linear. Nonetheless, a general stress-strain relation valid within a typical pressure range of a living being may be expressed by the following non-linear equation relating the transmural pressure and arterial cross-sectional area… since the elastic properties of arteries may change over time. The transmural pressure P may be determined from the pressure differential between the inside and the outside wall of an artery).
Regarding Claim 5, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as comparing data from piezoelectric sensors to past data (Paragraph [0097] - The signal-processing device 904 is configured to automatically analyze the wearable sensor data and compare that data to recently-recorded or historically-recorded data to allow for more accurate analysis of the signal data; Paragraph [0140] - During each cardiac cycle a comparison ellipse is generated, by the process 1920, for the best least squares fit of the hysteresis loop between the PPG sensor and the piezoelectric sensor outputs for both the measured (experimental) data and the projected (hypothetical fixed radius) data, as shown in FIG. 24). Ward et. al.’221 fails to disclose determining the second line fit profile of the signals indicative of the blood volume and/or blood circulation changes versus externally applied cuff pressure using a best fit optimization against a predetermined baseline fit profile. Lading et. al.'095 teaches using best fit methods against baseline values and externally applied pressure (Paragraph [0079] - the measured parameter(s) may be based on recording quantities related to a distension pulse (arterial expansion) or a flow pulse (blood flow velocity variation); Paragraph [0081] - the control unit may select a model from a set of models. The selection of a model may be based on best fit or other considerations. For example, fitting procedures may be used for the selection of the model, which may include a simple least squaring fitting or fitting including weights to values proportional to the corresponding applied external counter pressures. In addition, other techniques for fitting may be used such as least squares, weighted least squares (e.g., a fitting where the weighting is proportional to the counter pressure), iterative proportional fitting, matrix ranking, regression analysis, or differential or partial differential equation solutions. The model may be selected from a predetermined stress-strain relationship of the artery, a Bramwell-Hill equation, an exponential model, a bi-linear model, and/or others). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ward et. al.’221 to include comparing measurement data obtained during externally applied pressure to predetermined baseline data in order to account for change in distension – blood volume - of an artery changing over time as seen in Lading et. al.’095 (Paragraph [0028] - The diameter of arteries tend to become smaller with distance from the heart, and the elastic modulus of the vessel depends on the vessel distension; Paragraph [0042] - The outputs of the signals from the sensors 211, 212 may reflect the distension of the artery at the two sensor locations and would in general show the pulse shape over time, including the effects of any filtering).
Regarding Claim 21, the sections of Ward et. al.’221 in view of Lading et. al.’095 cited above in the rejection breakdown of Claim 3 disclose a method set forth in the claim.
Regarding Claim 23, the sections of Ward et. al.’221 in view of Lading et. al.’095 cited above in the rejection breakdown of Claim 5 disclose a method set forth in the claim.
Claims 6 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al.'221 (U.S. Patent Publication 20200054221 - cited by applicant) as applied to Claim 1 above, and further in view of Rooke et. al.'586 (U.S. Patent Publication 20100292586 – previously cited).
Regarding Claim 6, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as determine the first line fit profile of the signals indicative of the strain response versus externally applied cuff pressure by comparing the signals indicative of the strain response versus externally applied cuff pressure against a previously measured strain response signal curve through a Kalman filter - an error minimization filter (Paragraph [0146] - In an example herein, sensor data from both the PPG sensor 1904 and the PVDF sensor 1902 is provided to a state-space model that is used with extended Kalman filter to reduce signal error more quickly; Paragraph [0149] - The process 1920 provides these output models to an extended Kalman filter, also within the process 1920, that linearizes the nonlinear-state models for each new estimate of vascular radius, vascular resistance, and/or vascular stiffness, as the sensor data becomes available), but fails to disclose performing an error minimization until the first line fit profile corresponds to the measured strain response signal curve. Rooke et. al.'586 teaches applying an error minimizing filter to piezoelectric data until a desired “fit” has been achieved (Paragraph [0044] - The sensors 32, 34 can be constructed from any of a variety of devices that can sense changes in a physical condition and produce a related electrical signal. For example, piezoelectric elements, strain gauge; Paragraph [0072] - A curve fitting is next performed on the filtered or smoothed sample data for the sensor cuff DC pressure data waveform of FIG. 13 to obtain a relatively clean waveform from which the slope trends of the waveform can be more readily analyzed in further processing steps. The curve fitting is performed using the LabVIEW.RTM. "general polynomial fit" algorithm several times with incrementing values for the "order" input up to a "max fit order". The data from the fitting sequences that provides the lowest mean square error (MSE) is stored and is displayed at FIG. 13 as the "best" fit waveform (shown in solid line)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ward et. al.’221 to include applying an error minimization filter until a response signal curve meets a predetermined “fit” in order to provide cleaner piezoelectric data as seen in Rooke et. al.’586.
Regarding Claim 24, the sections of Ward et. al.’221 in view of Rooke et. al.'586 cited above in the rejection breakdown of Claim 6 disclose a method set forth in the claim.
Claims 7 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al.'221 (U.S. Patent Publication 20200054221 - cited by applicant) as applied to Claim 1 above, and further in view of Kwon et. al.'168 (U.S. Patent Publication 20170095168 – previously cited).
Regarding Claim 7, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as determine the second line fit profile of the signals indicative of the blood volume and/or blood circulation changes versus externally applied cuff pressure by comparing the signals indicative of the blood volume and/or blood circulation changes versus externally applied cuff pressure against a previously measured photoplethysmogram response signal curve through a Kalman filter - an error minimization filter (Paragraph [0146] - In an example herein, sensor data from both the PPG sensor 1904 and the PVDF sensor 1902 is provided to a state-space model that is used with extended Kalman filter to reduce signal error more quickly; Paragraph [0149] - The process 1920 provides these output models to an extended Kalman filter, also within the process 1920, that linearizes the nonlinear-state models for each new estimate of vascular radius, vascular resistance, and/or vascular stiffness, as the sensor data becomes available), but fails to disclose performing an error minimization until the second line fit profile corresponds to the measured photoplethysmogram response signal curve. Kwon et. al.'168 teaches applying an error minimizing filter to second PPG signals and corresponding them to first PPG signals (Paragraph [0108] - the blood pressure measurers 130 and 230 filter graphs of the first PPG signal and the second PPG signal through the LPF, and may acquire the first and second filtered PPG signals. The first and second filtered PPG signals become graphs in a smoother shape than graphs before filtering. Further, the blood pressure measurers 130 and 230 extract feature points from graphs obtained by differentiating the first filtered PPG signal and the second filtered PPG signal. Upon extracting the feature points, the blood pressure measurers 130 and 230 may measure a phase difference between the first PPG signal and the second PPG signal). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ward et. al.’221 to include applying an error minimizing filter to more recently measured PPG data and corresponding them to previously measured PPG data in order to produce smoother overall measured PPG data as seen in Kwon et. al.’168.
Regarding Claim 25, the sections of Ward et. al.’221 in view of Kwon et. al.'168 cited above in the rejection breakdown of Claim 7 disclose a method set forth in the claim.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al.'221 (U.S. Patent Publication 20200054221 - cited by applicant) as applied to Claim 1 above, and further in view of Axelrod'951 (WO Patent Publication 2020171951 – previously cited).
Regarding Claim 18, Ward et. al.’221 discloses the device outlined in Claim 1 above as well as an external cuff configured to apply the externally applied cuff pressure to the subject (Paragraph [0134] - a finger cuff, in which pressure is regulated to maintain a constant arterial volume), but fails to disclose wherein the external cuff is communicatively coupled to the processor for providing externally applied cuff pressure values to the processor. Axelrod'951 teaches an external blood pressure cuff in communication with a processor (Paragraph [0025] - Blood pressure measurement device controller 120 may also control the pneumatic pressure (e.g., utilizing a controllable valve) applied to the finger cuff 104 as well as other functions. In this example, the pneumatic pressure applied by the pump 134 to the bladder of finger cuff 104 to replicate the patient’s blood pressure based upon measuring the pleth signal received from the LED-PD pair of the finger cuff 104 (e.g., to keep the pleth signal constant) and measuring the patient’s blood pressure by monitoring the pressure of the bladder may be controlled by the blood pressure measurement controller 120 and/or a remote computing device and/or the pump 134 and/or the patient monitoring device 130 to implement the volume clamping method). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ward et. al.’221 to include a processor communicatively coupled to a blood pressure cuff in order to control the pneumatic pressure applied as well as observe how much pressure is being applied to the subject as seen in Axelrod’951.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding Claim 10, none of the prior art teaches or suggests, either alone or in combination, a 2D model comprising expressions recited in the claim. Ward et. al.’221 discloses the closest formulas reciting the following:
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Response to Arguments
Applicant's arguments filed 22 July 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior drawing objections.
Applicant’s amendments have overcome the prior specification objections.
Applicant’s amendments have overcome the prior claim objections.
Applicant’s amendments have overcome the prior 35 U.S.C. 112b rejections.
Applicant’s amendments and reasons regarding overcoming the prior 35 U.S.C. 101 rejections were considered, but were found not to be persuasive. The examiner has interpreted the Abstract Idea "determine a blood pressure and/or a systemic vascular resistance" under mathematical concepts provided that they are reliant on determining "line fit features". The additional element that these steps are performed by a processor is a generic computing device and as cited in the OA, using a processor as a generic computing device falls under section 2106.05(f) of the MPEP wherein "using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application". Additionally, the steps and functions comprising the "physical structures" such as the "strain sensor", "PPG sensor", and "support structures" remain interpreted by the examiner to be elements used to obtain the data inputted into the processor and therefore are seen as "pre-solution" data gathering elements. These "physical structures" (as referred by the applicant) do not help overcome the current 101 Rejection provided that they are not believed to be unique in use over the prior art of record and therefore are not considered a "particular machine" used to overcome the Abstract Idea as recited in section 2106.05(b) of the MPEP. Furthermore, a "strain sensor" being used to obtain data pertaining to "strain response" and a "PPG sensor" being used to obtain data pertaining to "blood volume and/or blood circulation" are conventional in the art, as evidenced by the prior art of record, and therefore are examples of insignificant extra-solution data gathering according to section 2106.05(g) of the MPEP. The analysis of the 101 rejection is in Paragraph 3 above.
The examiner has considered the applicant’s reasons pertaining to the current prior art of record Ward et. al.’221 failing to provide a pressure cuff collecting data, but these arguments were found not to be persuasive. The applicant argues on Page 7 of the Remarks submitted on 22 July 2026 that "no pressure data is collected from the cuff itself". However, the examiner notes that the current recitation of the claims do not require the blood pressure cuff itself to record data. Rather, Claim 1 currently recites "a processor…configured to…collect signals indicative of the strain response and the signals indicative of the blood volume and/or blood circulation during changes in an externally applied cuff pressure" (emphasis added). This current recitation of the claims permit a system to obtain measurement data corresponding or correlating to the effects a pressure cuff has on a user. They do not require a pressure cuff itself to obtain measurements and/or readings.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dana et. al.'188 (U.S. Patent Publication 20190298188), Narasimhan'953 (U.S. Patent Publication 20190104953), and Lui'323 (U.S. Patent Publication 20180360323) disclose wearable devices configured to obtain blood pressure measurements. Dana et. al.’188 discloses a finger device capable of correlating multiple measurements to one another such as blood pressure and blood flow. Narasimhan’953 discloses a finger device capable of obtaining capacitance variation measurement values caused by blood pressure changes. Lui’323 discloses a wearable device capable of converting multiple measurement values such as ECG and PPG to blood pressure values.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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