DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 01/12/2026 has been entered. Amendments to claims 1, 2, 14, and 16 are acknowledged. Claims 1-20 remain pending in the application.
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 1-20 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.
Claims 1 and 14 recite the limitation “candidate component”. It is unclear what the candidate component refers to within the venous wave. Applicant’s specification paragraph [0035] states “the pulse wave information includes the candidate component is determined based on, for example, a change in an amplitude of the waveform of the cuff pulse wave.” and paragraph [0054] states “The candidate component C is detected when the cuff pressure is P1”. The descriptions disclose how to determine whether the candidate component is included in the signal but lack a definition as to the characteristics of the component itself. Further, while Figs 4, 6, and 7 display the candidate component contained within the overall signal, they do not clarify what qualities of the signal distinguish the highlighted section as a candidate component, and each figure displays a different structure for the component. Claim 19 states that “the candidate component is determined based on whether the pulse wave information exhibits a predetermined amplitude at a predetermined time and at least one noise component has an amplitude lower than the predetermined amplitude.”, but additionally does not state what the component is, only that it may be determined. For the purposes of examination, “candidate component” will be interpreted as any characteristic of the signal.
Claims 2-13 and 15-20 are rejected due to dependency.
Claim Rejections - 35 USC § 101
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “to obtain pulse wave information on a pulse wave of a subject measured by a sensor” and “calculate a value of venous pressure of the subject based on a candidate component included in the pulse wave when the venous pressure of the subject is estimatable from the pulse wave information, wherein the controller is configured to calculate a value range as the venous pressure of the subject, based on the pulse wave information, when the venous pressure of the subject is not estimatable from the pulse wave information, and wherein the candidate component is a component that is estimatable as a venous wave of the subject, the component being included in the pulse information.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a controller”, “a sensor”, and “a processing unit” in claim 1, and “display” and “cuff” in claim 20. “Sensor” and “cuff” are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0002]: “there is widely used a method in which a pressure unit such as a cuff” of Takoh et al. (US 20170172429 A1), hereinafter Takoh. “Display” is additionally not “significantly more” because it is well-known, routine, and/or conventional as evidenced by Takoh para [0107]: “an LCD (Liquid Crystal Display), an OLED (Organic light emitting diode), an electronic paper, or the like.” and Mashak (US 20060213517 A1) para [0031]: “personal audio speaker components/arrangements or a video display, all of which are well known in the art.”. Furthermore, the “controller” is not “significantly more” because a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-13 and 16-20 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 1-13 and 16-20 is/are rejected under 35 U.S.C. 101.
Claim 14 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 14 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “obtaining pulse wave information on a pulse wave of a subject measured by a sensor” and “calculating a value of a venous pressure of the subject based a candidate component included in the obtained pulse wave information when the venous pressure of the subject is estimatable from the obtained pulse wave information”, and “calculating a value range as the venous pressure of the subject, based on the pulse wave information, when the venous pressure of the subject is not estimatable from the pulse wave information, wherein the candidate component is a component that is estimatable as a venous wave of the subject, the component being included in the pulse information.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a sensor”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0002]: “there is widely used a method in which a pressure unit such as a cuff” of Takoh. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 14 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 15 fail to cure the deficiencies of independent claim 14 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 14-15 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LeBoeuf et al. (US 20200138381 A1).
Regarding claim 1, LeBoeuf discloses a venous pressure measurement device ([0016]: “and the at least one sensor metric comprises blood pressure.,”) comprising: a controller ([0011]: “and a signal processor configured to process signals from the sensor into a serial data stream of physiological information”) configured to obtain pulse wave information on a pulse wave of a subject measured by a sensor ([0016]: “the at least one sensor element is a PPG sensor, the physiological data includes PPG data”); and calculate a value of venous pressure (Fig 4) of the subject based on a candidate component included in the pulse wave when the venous pressure of the subject is estimatable from the pulse wave information ([0065]: “that a true mean value can be calculated and plotted at the center of distribution”, wherein the candidate component is the true mean), wherein the controller is configured to calculate a value range as the venous pressure of the subject, based on the pulse wave information ([0065]: “the user will know that there is a 95% chance that the expected value (the true blood pressure value) is within about two (˜2) standard deviations of the estimated number. An alternate methodology would be to only plot out the presentation 40 of FIG. 4 after multiple estimates of blood pressure had been generated, such that a true mean value can be calculated”, wherein the range is two standard deviations), when the venous pressure of the subject is not estimatable from the pulse wave information ([0053]: “metric integrity information may comprise numerical information on the “confidence” that the sensor readings are correct, wherein a higher confidence reading implies a higher confidence that the sensor is generating physiologically correct information as opposed to unwanted noise information (such as unwanted motion-, electrical-, or environmental-artifacts).”, [0059]: “high signal quality of a given threshold value may correspond with a 100% confidence threshold, such that sensor readings or sensor biometrics associated with signal qualities higher than the threshold value may be assumed to be accurate with a probability of 100%.”, Fig 4 confidence interval metric, wherein when the metric integrity is below 100%, an exact blood pressure cannot be estimated and range is calculated), and wherein the candidate component is a component that is estimatable as a venous wave of the subject, the component being included in the pulse information ([0065]: “that a true mean value can be calculated and plotted at the center of distribution”).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-15 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa (JP H05207979 A) in view of Sathya et al. (US 20190200879 A1), hereinafter Sathya.
Regarding claim 1, Furukawa discloses a venous pressure measurement device comprising: a controller configured to: obtain pulse wave information on a pulse wave of a subject measured by a sensor ([0001]: “cuff to the portion to be measured, such as the patient's upper arm, to detect a pulse in a state”); calculate a value of a venous pressure of the subject based on a candidate component included in the pulse wave information when the venous pressure of the subject is estimatable from the pulse wave information ([0004]: “when there is no change of greater than or equal to a predetermined value β0 between i mutual, the pressure value data pulse wave value of the original presi data LVi the exit detection, the process proceeds to the detection of the pulse wave value data LVi + 1 under the pressure value data PRESI + 1 in the next step with reduced constant level by the pressure value”, wherein the pressure is estimable when the change is not greater than the predetermined value), and wherein the controller is configured to calculate a value as the venous pressure of the subject, based on the pulse wave information, when the venous pressure of the subject is not estimatable from the pulse wave information ([0046]: “That is, it can be estimated to have been affected by noise components, such as variations due to body movement and respiration. Thus, in order to alleviate the impact, it is to take the average value of two times of the pulse wave value data LV, LV1 to before and after phase.”, wherein the data set is modified in response to the noise component being detected, after which a pressure is calculated), and wherein the candidate component is a component that is estimatable as a venous wave of the subject, the component being included in the pulse information ([0004], wherein the candidate component is a part of the wave compared to the threshold).
Furukawa fails to disclose that the pressure calculated is a value range as the venous pressure of the subject.
Sathya discloses a method of estimating a range of blood pressure values ([0015]: “estimating a range of systolic and diastolic pressures”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Furukawa to include the range of estimated blood pressures as disclosed by Sathya in order to account for error due to variability during blood pressure collection (Sathya [0006]: “variations of systolic, diastolic and therefore mean pressures that occur with respiration and the pulse pressure assessment can be very erroneous depending on the profile of deflation.”).
Regarding claim 2, Furukawa further discloses the processing unit is further configured to determine whether the venous pressure of the subject is estimatable from the pulse wave information based on a noise component affected by disturbance and a candidate component ([0004]: “during one measuring cycle, detected over a plurality of times the pulse wave value data LV in under the same pressure value data PRESI, phase before and after the pulse wave value data LV (j) i, LV (j-1) when there is no change of greater than or equal to a predetermined value β0 between i mutual, the pressure value data pulse wave value of the original presi data LVi the exit detection, the process proceeds to the detection of the pulse wave value data LVi + 1 under the pressure value data PRESI + 1 in the next step with reduced constant level by the pressure value.”).
Regarding claim 3, Furukawa further discloses wherein the processing unit is configured to determine that the venous pressure of the subject is not estimatable from the pulse wave information when the pulse wave information includes the noise component satisfying the predetermined condition ([0004]).
Regarding claim 4, wherein the processing unit is configured to estimate the venous pressure of the subject from the pulse wave information when the pulse wave information includes the candidate component and does not include the noise component satisfying the predetermined condition. ([0043]: “In step S5-9, it is determined whether the current pulse wave value data LV is within a predetermined range from 80% of the pressure value difference minimum pulse wave value data lv to 120%... the process proceeds to step S5-10…. and is not affected by noise components”).
Regarding claim 5, Furukawa further discloses the processing unit is further configured to determine whether the value range of the venous pressure of the subject is calculable based on the pulse wave information obtained by the obtaining unit ([0004]).
Regarding claim 6, Furukawa further discloses wherein the processing unit is configured to calculate the value range of the venous pressure of the subject when the pulse wave information does not include the noise component satisfying the predetermined condition and the candidate component ([0046]: “S5-9, it may occur if the current pulse wave value data LV is not within a predetermined range from 80% of the pressure value difference minimum pulse wave value data lv to 120%. In other words, there are times when that becomes the LV ⟨0.8 × lv or LV⟩ 1.2 × lv.”).
Regarding claim 7, Furukawa discloses the processing unit is configured to calculate the value range of the venous pressure of the subject or determine that an error has occurred when the pulse wave information includes the noise component satisfying the predetermined condition and does not include the candidate component ([0046], wherein further steps are taken when the pulse wave is not within the range and the noise component is present, thus constituting determining an error).
Regarding claim 8, Sathya further discloses wherein the processing unit is configured to calculate the value range of the venous pressure of the subject ([0015]: “estimating a range of systolic and diastolic pressures”) or determine that an error has occurred when the pulse wave information includes the noise component satisfying the predetermined condition and the candidate component.
Regarding claim 9, Furukawa further discloses wherein the processing unit is configured to determine whether the value range of the venous pressure of the subject is calculable based on at least one of a position, a period length, a number, and a magnitude of the noise component ([0004-0005]).
Regarding claim 10, Furukawa further discloses wherein the sensor is a cuff attached to a predetermined portion of the subject, and the obtaining unit is configured to obtain the pulse wave information based on pressure received by the cuff from the predetermined portion when cuff pressure of the cuff is changed ([0001]: “is wrapped around the cuff to the portion to be measured, such as the patient's upper arm, to detect a pulse in a state where the pressure to be measured part by air compressed air to the cuff,”).
Regarding claim 11, Furukawa further discloses wherein the processing unit is configured to calculate the value range of the venous pressure of the subject based on the pulse wave information and pressure information on the cuff pressure ([0001]).
Regarding claim 12, Furukawa discloses wherein the processing unit is configured to determine that the pulse wave information includes the candidate component when an amplitude of the pulse wave of the subject changes in a predetermined manner in accordance with a change in the cuff pressure. ([0043]: “In step S5-9, it is determined whether the current pulse wave value data LV is within a predetermined range from 80% of the pressure value difference minimum pulse wave value data lv to 120%. When you are within a predetermined range, that is, when 0.8 × lv ≦ LV ≦ 1.2”, wherein the wave’s amplitude must be within the given range)
Regarding claim 13, Furukawa discloses an output unit configured to output any one of a calculation result regarding the value range of the venous pressure of the subject calculated by the processing unit ([0011]: “display on the display unit”), an estimation result regarding the venous pressure of the subject estimated from the pulse wave information ([0011]: “determined from the pulse wave value data, systolic blood pressure, the lowest blood pressure value , it is to display on the display unit, respectively”), and an error result indicating that the estimation of the venous pressure of the subject and the calculation of the value range of the venous pressure of the subject are not performable.
Regarding claim 14, Furukawa discloses a venous pressure measurement method comprising: obtaining pulse wave information on a pulse wave of a subject measured by a sensor ([0001]: “cuff to the portion to be measured, such as the patient's upper arm, to detect a pulse in a state”); calculating a value of a venous pressure of the subject based on a candidate component included in the pulse wave information when the venous pressure of the subject is estimatable from the pulse wave information ([0004]: “when there is no change of greater than or equal to a predetermined value β0 between i mutual, the pressure value data pulse wave value of the original presi data LVi the exit detection, the process proceeds to the detection of the pulse wave value data LVi + 1 under the pressure value data PRESI + 1 in the next step with reduced constant level by the pressure value”, wherein the pressure is estimable when the change is not greater than the predetermined value), and wherein the controller is configured to calculate a value as the venous pressure of the subject, based on the pulse wave information, when the venous pressure of the subject is not estimatable from the pulse wave information ([0046]: “That is, it can be estimated to have been affected by noise components, such as variations due to body movement and respiration. Thus, in order to alleviate the impact, it is to take the average value of two times of the pulse wave value data LV, LV1 to before and after phase.”, wherein the data set is modified in response to the noise component being detected, after which a pressure is calculated), and wherein the candidate component is a component that is estimatable as a venous wave of the subject, the component being included in the pulse information ([0004], wherein the candidate component is a part of the wave compared to the threshold).
Furukawa fails to disclose that the pressure calculated is a value range as the venous pressure of the subject.
Sathya discloses a method of estimating a range of blood pressure values ([0015]: “estimating a range of systolic and diastolic pressures”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Furukawa to include the range of estimated blood pressures as disclosed by Sathya in order to account for error due to variability during blood pressure collection (Sathya [0006]: “variations of systolic, diastolic and therefore mean pressures that occur with respiration and the pulse pressure assessment can be very erroneous depending on the profile of deflation.”).
Regarding claim 15, Furukawa further discloses a non-transitory computer-readable storage medium storing a program causing a computer to perform the venous pressure measurement method according to claim 14 ([0024]: “micro-computer for equipped with a timer to run the program of blood pressure measurement,”).
Regarding claim 19, Furukawa further discloses wherein the controller is configured to determine whether the venous pressure of the subject is estimatable based whether the pulse wave information includes a candidate component ([0004]: “during one measuring cycle, detected over a plurality of times the pulse wave value data LV in under the same pressure value data PRESI, phase before and after the pulse wave value data LV (j) i, LV (j-1) when there is no change of greater than or equal to a predetermined value β0 between i mutual, the pressure value data pulse wave value of the original presi data LVi the exit detection, the process proceeds to the detection of the pulse wave value data LVi + 1 under the pressure value data PRESI + 1 in the next step with reduced constant level by the pressure value.”), and wherein the candidate component is determined based on whether the pulse wave information exhibits a predetermined amplitude at a predetermined time and at least one noise component has an amplitude lower than the predetermined amplitude ([0005]: “Then, the pulse wave value data L. It is determined whether the difference between V (2) i = 1 and LV (1) i = 1 is less than or equal to a predetermined value β 0 . That is, | LV (2) i = 1− LV (1) i = 1 | ≦ β 0”).
Regarding claim 20, Furukawa further discloses further comprising an output device comprising a display; wherein the sensor is a cuff attached to a predetermined portion of the subject ([0001]: “to wrap a cuff band around a part to be measured such as an upper arm of a patient”) or a photoplethysmogram (PPG) sensor, and wherein the controller is configured to display the calculated value range of the venous pressure on the display ([0012]: “The systolic blood pressure and the diastolic blood pressure value are determined and displayed on the display unit.”).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa in view of Sathya in further view of Fathieh et al. (US 20210212582 A1), hereinafter Fathieh.
Regarding claim 16, Furukawa as modified by Sathya discloses wherein the controller is configured to determine whether the venous pressure of the subject is estimatable based on whether the pulse wave information includes a noise component having a magnitude greater than or equal to a predetermined magnitude amplitude ([0005]: “Then, the pulse wave value data L. It is determined whether the difference between V (2) i = 1 and LV (1) i = 1 is less than or equal to a predetermined value β 0 . That is, | LV (2) i = 1− LV (1) i = 1 | ≦ β 0”), a plurality of noise components greater than or equal to a predetermined threshold, or the period of the noise component greater than or equal to a predetermined period, and wherein the noise component is due to respiration, arrhythmia, and/or body movement ([0073]: “has been affected by noise components such as fluctuations due to body movements and respirations”).
Furukawa fails to disclose wherein the controller is configured to determine whether the venous pressure of the subject is estimatable based on a frequency analysis of the noise component or the plurality of noise components, wherein the noise component is due to respiration, arrhythmia, and/or body movement.
Fathieh discloses wherein the controller is configured to determine whether the venous pressure of the subject is estimatable ([0009]: “wherein the rejection generates a notification to be presented cardiac measurement equipment or a remote terminal (e.g., to trigger the re-acquisition or second acquisition of the biophysical signal data set from the mammalian subject”, wherein if the data set is rejected, the blood pressure cannot be estimated from the given data set) based on a frequency analysis of the noise component or the plurality of noise components ([0221]: “the signal quality assessment operation of module 130 is configured to quantify biopotential signal noise metrics, including, but not limited to metrics associated with biopotential powerline interference and biopotential high-frequency noise…frequency content above 170 Hz, in such embodiments, is not necessarily periodic and can include pulses and other such artifacts.”), wherein the noise component is due to respiration, arrhythmia, and/or body movement ([0225]: “Examples of noise relevant to the present disclosure include, for example, powerline interference, high frequency noise, high frequency noise bursts, (abrupt) baseline movement, and cycle variability.”, [0276]: “In addition to the biopotential activity, respiration affects the PPG signals, too”).
It would have been obvious to a person of ordinary skill in the art to substitute the known method of noise analysis disclosed by Furukawa with the known method of frequency noise analysis disclosed by Fathieh for the predictable result of determining whether or not a venous pressure is estimable.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa in view of Sathya in further view of Quinn (US 20110313300 A1).
Regarding claim 18, Furukawa in view of Sathya discloses the device of claim 1 but fails to disclose wherein the controller is configured to determine whether the venous pressure of the subject is estimatable based on a change rate of the pulse wave information.
Quinn discloses a blood pressure measurement device wherein the controller is configured to determine whether the venous pressure of the subject is estimatable ([0021]: “When artifact noise is introduced into the system, it can be difficult to distinguish between the changes in pressure caused by the underlying artery and those caused by the noise. Tracking the stability and consistency of this baseline pressure allows the detection of artifact noise and pulse altering changes in the cuff pressure that are not due to cardiogenic pulsations in the artery.” ) based on a change rate of the pulse wave information ([0041]: “a problem can occur with the oscillometric measurement when the static BLP is not stable due to artifact noise that is introduced when the signal is measured. For example, the pulse 510 exhibits a stable BLP, similar to the pulses 110 shown in FIGS. 1 and 2. However, the pulse 520 illustrates a baseline pressure BLP2 that is rising at a significant rate during the course of the measurement during to artifact noise.”).
It would have been obvious to a person of ordinary skill in the prior to the effective filing date to modify the device disclosed by Furukawa in view of Sathya to include the method of determining whether the venous pressure of the subject is estimatable based on a change rate of the pulse wave information in order to identify noise caused by unstable pulse waves (Quinn [0043]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa in view of Sathya in further view of Habu et al. (US 20080243008 A1), hereinafter Habu.
Regarding claim 18, Furukawa in view of Sathya discloses the device of claim 1 but fails to disclose wherein the controller is configured to determine whether the venous pressure of the subject is estimatable based on a signal from an acceleration sensor.
Habu discloses a blood pressure measurement device (abstract) wherein the controller is configured to determine whether the venous pressure of the subject is estimatable based on a signal from an acceleration sensor ([0070]: “blood pressure values determined from the pressure pulse wave depending on whether a value obtained by the accelerometer exceeds a predetermined value C. It is desirable to select the systolic and diastolic blood pressure values determined from the photoelectric pulse wave by determining that accurate blood pressure cannot be obtained from the pressure pulse wave due to body movements during measurement if the predetermined value C is exceeded”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Furukawa in view of Sathya to further include the determination of if the venous pressure is estimatable as disclosed by Habu in order to account for noise caused by body motion affecting blood pressure measurement (Habu [0003]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/12/2026, with respect to 35 U.S.C.§112(a) of claims 1-20 have been considered and is persuasive. The rejection of claims 1-20 under 35 U.S.C.§112(a) is withdrawn. The 35 U.S.C.§112(b) rejection of claims 1-20 have been fully considered and are not persuasive. Applicant argues that the application discloses a structure for the disclosed "candidate component" in claim 19. Applicant argues on page 7 of the Remarks that "the application's repeated characterization that the candidate component is defined by its amplitude-envelope". This language however is neither in the claims nor specification. Applicant, and the previous office action, cites para [0035]: "Whether the pulse wave information includes the candidate component is determined based on, for example, a change in an amplitude of the waveform of the cuff pulse wave". The para specifies that the component is included when there is a change in amplitude, not that the component itself is a change in amplitude. In fact, this is point is contradicted by claim 19, wherein the candidate component "is determined based on whether the pulse wave information exhibits a predetermined amplitude at a predetermined time", which does not relate to a change in amplitude but a static amplitude value. Of note, claim 19 also specifies that the candidate component's presence is determined based on an amplitude, not that the candidate component is the amplitude. Applicant further cites para [0039]: “the pulse wave information includes the candidate component C of the period Tv that can be estimated as the venous wave of the subject and does not include any noise component affected by disturbance”, which states that the candidate component is included within the wave and can be further estimated as the venous wave, but does not specifically provide structure for the component. Additionally, para [0039] states that the component may be estimated and does not include any noise component, implying that some other quality defines the candidate component in addition to being free of noise. This is further supported by claim 3, wherein the lack of a candidate component is determined separate from the inclusion of a noise component satisfying a predetermined condition. Looking again to Figs 4, 5, and 6, it’s unclear what distinguishes the section C from the other parts of the waveform. Para [0054] discloses that the candidate component C is detected when the cuff pressure is P1, but the section of the waveform disclosed as "C" in the corresponding Fig 6 is not markedly different from the preceding or following waveform. Applicant cites para [0051] and [0053] on page 8 of Remarks to disclose that the candidate component is a change in amplitude dependent on the noise. Para [0051] does not disclose "the candidate component is a segment of the pulse wave that exhibits a predetermined amplitude while noise is lower". Para [0051] instead discloses “the determination unit determines that the value range of the venous pressure cannot be calculated when the number, the magnitude, or the like of the noise component exceeds a predetermined value, and determines that the value range of the venous pressure can be calculated when the number, the magnitude, or the like of the noise component is equal to or smaller than the predetermined value”. The para specifies that the pressure can be calculated or cannot be calculated based on a noise component. Para [0053] further discloses that a candidate component is not included within the pulse wave information. Absence of the component cannot define a structure for it. Neither paragraph, nor other parts of the disclosure, clearly defines or implies what specifically constitutes a candidate component, only that it is or is not detected.
Applicant's arguments filed see Remarks with respect to 35 U.S.C.§103 rejections of claims 1-15 have been fully considered but they are not persuasive. Applicant alleges on pages 11-12 of Remarks there is a difference between "usable" and "estimable" values. If a data set contains an amount of noise that makes it unable to be used for an accurate calculation, it can be said that the data cannot be used to estimate a blood pressure value. It is unclear how estimable differs from usable. Applicant states on page 12 that a measurement that is not accurate is not the same as not estimable. But given any pulse wave values, one could calculate a venous pressure. If the value is radically different from the true pressure, it is not representative of the pressure. As such, the pressure is not estimable based on the data. The claim language is further consistent with this, as whether or not data is estimable is determined based on inclusion of noise components and components of the waveform, which is further disclosed by Furukawa. If Applicant is alleging that the data is completely unusable (for example if the data is undefined as applicant is claiming per remarks page 12), then it's unclear how that same data can then be used to calculate a range of values. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Sathya discloses that a range of pressures is more accurate than a single pressure (see rejection above), thus there is an obvious motivation to improve the calculated pressure. Regarding applicant’s arguments that Furukawa does not teach a candidate component on page 14, a candidate component is not clearly defined, and claim 1 states that a candidate component is a component that is estimatable as a venous wave of the subject.
Applicant's arguments filed see Remarks, filed 07/25/2025, with respect to 35 U.S.C.§101 rejections of claims 1-15 have been fully considered but they are not persuasive. Applicant argues on page 9 of applicant's remarks that obtaining pulse wave information from a human body is not directed to a mental process. However, reading sensor information is a mathematical calculation that may be performed by the human mind, and a sensor is a routine, conventional, and well-known element (see rejection above). Applicant further argues that the human mind is not equipped to calculate a value range of pulse wave information when that data is not estimable from pulse wave information as even a computer/processor would be unable to do so. However, if the process is too computationally intense for a computer to calculate the pulse wave range, it is unclear as to how the processor/controller disclosed is capable of doing so. Given a set of pulse wave data, a human equipped with a pen and paper would be capable of determining a noise level, identifying a candidate component, and determining a range of values.
Conclusion
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791