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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 12, 2025 has been entered.
Response to Amendment
The Amendment filed August 12, 2025 has been entered. Claims 1, 3, 5-6, 12-14 and 16-17 remain pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3, 5-6, 12-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Newberry et al. (US 2020/0237317 A1) (“Newberry”) in view of Asvadi et al. (US 2021/0059536 A1) (“Asvadi”) in further view of Ishihara et al. (US 2020/0221961 A1) (“Ishihara”) in further view of Kang et al. (US 2019/0387985 A1) ("Kang").
Regarding claims 1 and 13, Newberry discloses An apparatus/method for estimating blood pressure, the apparatus comprising (Abstract and entire document):
a pulse wave sensor configured to measure from an object, a plurality of pulse wave signals having different wavelengths, wherein the pulse wave sensor comprises one or more light sources configured to emit light of the different wavelengths to the object, and one or more detectors configured to detect the light of the different wavelengths reflected or scattered from the object ([0217-0221], see [0219], “In an embodiment described herein, this change in propagation of the pressure wave can be measured in the change in transfer function from a wavelength that penetrates the tissue deeply (e.g. in the IR range) to a wavelength that penetrates tissue much less deeply (e.g. in the visible or UV range). This means that by measuring the change in shape and time delay of PPG signals of two or more wavelengths with different penetration depths (e.g., wherein at least one is in the near-IR window and one is not), information about vasodilation/vasoconstriction may be determined. Also, because the transfer function between the two depths of penetration is affected by blood pressure, blood viscosity, tissue absorption, and, in general, cardiovascular health, these other parameters can be characterized as well.” PPG, pulse wave sensor at multiple wavelengths. See also FIG. 15);
a force sensor configured to measure a contact force applied by the object to the pulse wave sensor ([0043], “As illustrated in FIG. 1 and FIG. 2, according to some embodiments, the system 10, 20 may comprise a force sensor 116.”);
a processor configured to extract, from the plurality of pulse wave signals, a similarity feature indicating a similarity between the plurality of pulse wave signals ([0105] discussing processors. See also [0217], “Thus, the deeper penetrating wavelengths (such as IR light) detect a pressure wave first followed by the lesser penetrating wavelengths (such as visible then UV light). The time delay in the “bulge” or pressure wave moving from the lower tissue into the upper tissue thus creates a time delay in a pressure waveform seen in the PPG signals at different wavelengths. For example, as seen in FIG. 15, a waveform in the UV range has a time delay compared to a waveform in the IR range and a waveform in the visible range (390 nm to 700 nm). This time delay in the different wavelengths is thus due to the depth of penetration into the skin of each wavelength.” The different pulse waves at each wavelength are compared., see also [0219], “This means that by measuring the change in shape and time delay of PPG signals of two or more wavelengths with different penetration depths (e.g., wherein at least one is in the near-IR window and one is not), information about vasodilation/vasoconstriction may be determined.”), and
wherein the processor is further configured to: obtain a plurality of beat pulses by beat parsing each of the plurality of pulse wave signals (FIG. 9B shows a waveform parsed into a beat cycle. See also FIG. 38 and associated paragraphs showing a normalized and parsed ppg data);;
normalize each of the plurality of beat pulses (FIG. 38 and associated paragraphs showing a normalized and parsed ppg data); and
extract, as the similarity feature, a minimum value of a time delay between the plurality of beat pulses (FIG. 38 and associated paragraphs showing a normalized and parsed ppg data. The bottom graph in FIG. 38 shows the time difference. See at least para. [0320 – [0322] discussing the phase difference. [0320] discussed difference in graphs according to the wavelength and a shape comparison. See also [0237] discussing cross correlation and comparing pulse shape and phase shift at each time point from the cross correlation phase shift and wavelet transformations, which includes both the minimum time delay and maximum degree of sameness),
wherein the processor is further configured to: extract at least one of an onset point, an offset point, a max slope point, and a tangent max point from each of the plurality of beat pulses (FIG. 38 and associated paragraphs showing a normalized and parsed ppg data. The bottom graph in FIG. 38 shows the time difference. See at least para. [0320 – [0322] discussing the phase difference. [0320] discussed difference in graphs according to the wavelength and a shape comparison.); and
obtain the time delay by calculating at least one of a first time difference between the onset points extracted from each of the plurality of beat pulses, a second time difference between the offset points extracted from each of the plurality of beat pulses, a third time difference between the max slope points extracted from each of the plurality of beat pulses, and a fourth time difference between the tangent max points extracted from each of the plurality of beat pulses (FIG. 38 and associated paragraphs showing a normalized and parsed ppg data. The bottom graph in FIG. 38 shows the time difference. See at least para. [0320 – [0322] discussing the phase difference. [0320] discussed difference in graphs according to the wavelength and a shape comparison.).
Newberry fails to disclose estimate the blood pressure based on the similarity feature and the contact force that is measured at a point in time at which the at least one similarity feature is extracted; and
a display configured to output guide information regarding the contact force between the object and a sensor surface in response to receiving a request for estimating the blood pressure,
wherein the processor is further configured to: generate an oscillometric envelope based on the plurality of pulse wave signals and the contact force measured by the force sensor;
obtain an additional feature using the generated oscillometric envelope; and wherein the additional feature is a maximum point of an amplitude of the oscillometric envelope.
estimate the blood pressure by applying the similarity feature, the contact force, and the additional feature to a predefined blood pressure estimation model,
However, in the same field of endeavor, Asvadi teaches estimate the blood pressure based on the similarity feature and the contact force that is measured at a point in time at which the at least one similarity feature is extracted ([0053], “FIG. 4 illustrates a method 200 for determining a blood pressure measurement for a subject 102 according to an embodiment….The intensity of light 108 of the first wavelength range and the intensity of light 112 of a second wavelength range change as a function of the force at which the light sensor 106 is applied to the skin 110 of the subject 102. Thus, the intensity of light 108 of the first wavelength range and the intensity of light 112 of a second wavelength range are dependent on the force at which the light sensor 106 is applied to the skin 110 of the subject 102.” The blood pressure is estimated based on a comparison between the pulse waves at different wavelengths and the force during each measurement. See also [0062] and fig. 5 and associated paragraphs); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus/method as taught by Newberry to include estimate the blood pressure based on the similarity and the contact force that is measured at a point in time at which the at least one similarity feature is extracted as taught by Asvadi in order to account for wavelength changes according to force ([0053], “The intensity of light 108 of the first wavelength range and the intensity of light 112 of a second wavelength range change as a function of the force at which the light sensor 106 is applied to the skin 110 of the subject 102.”).
Newberry as modified fails to disclose a display configured to output guide information regarding the contact force between the object and a sensor surface in response to receiving a request for estimating the blood pressure,
However, in the same field of endeavor, Ishihara teaches a display configured to output guide information regarding the contact force between the object and a sensor surface in response to receiving a request for estimating the blood pressure ([0113], discussing guide information based on contact force and location of sensor, see also [0100] discussing pressing force in relation to blood pressure monitoring to satisfy a condition as claimed),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus/method as taught by Newberry as modified to include a display configured to output guide information regarding the contact force between the object and a sensor surface in response to receiving a request for estimating the blood pressure as taught by Ishihara in order to achieve accurate measurements ([0107], “The attachment state being evaluated as “OK” indicates that the relative positional relationship between the sensor unit 40 and the measurement site is a relationship in which the accuracy of blood pressure measurement based on PTT can be achieved.”).
Newberry as modified fails to disclose wherein the processor is further configured to: generate an oscillometric envelope based on the plurality of pulse wave signals and the contact force measured by the force sensor;
obtain an additional feature using the generated oscillometric envelope; and wherein the additional feature is a maximum point of an amplitude of the oscillometric envelope.
estimate the blood pressure by applying the similarity feature, the contact force, and the additional feature to a predefined blood pressure estimation model,
However, in the same field of endeavor, Kang teaches wherein the processor is further configured to: generate an oscillometric envelope based on the plurality of pulse wave signals and the contact force measured by the force sensor (FIG. 5A-5B and [0087], “Then, as illustrated in FIG. 5B, the envelope obtainer 340 may obtain an oscillometric envelope OW by plotting the peak-to-peak amplitude at each measurement time with respect to a contact pressure value of the conversion signal.”);
obtain an additional feature using the generated oscillometric envelope; and wherein the additional feature is a maximum point of an amplitude of the oscillometric envelope (FIG. 5A-5B and [0110], “Subsequently, the bio-information measuring apparatus 200 may obtain an oscillometric envelope based on the multi-wavelength pulse wave signals and the obtained conversion signal in operation 840, and may measure bio-information based on the obtained oscillometric envelope in operation 850. For ample, the bio-information measuring apparatus 200 may extract one or more features from the oscillometric envelope, and may measure bio-information, such as blood pressure, by using the extracted features.”).
estimate the blood pressure by applying the similarity feature, the contact force, and the additional feature to a predefined blood pressure estimation model (FIG. 5A-5B and [0094], “For example, when measuring blood pressure, the bio-information measurer 350 may calculate, as mean arterial pressure (MAP), the contact pressure value MP of the maximum peak of the oscillometric envelope OW.” See also [0095 – 0096] and [0081-0083] discussing similarity/correlation; Using contact force, max amplitude of the envelope and additional features and additionally the multiwavelength/similarity features as taught by Newberry/Asvadi to estimate the blood pressure),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus/method as taught by Newberry as modified to include wherein the processor is further configured to: generate an oscillometric envelope based on the plurality of pulse wave signals and the contact force measured by the force sensor; obtain an additional feature using the generated oscillometric envelope; and wherein the additional feature is a maximum point of an amplitude of the oscillometric envelope estimate the blood pressure by applying the similarity feature, the contact force, and the additional feature to a predefined blood pressure estimation model as taught by Kang to estimate the blood pressure using the shape of the pulse wave and additional features ([0005], “As the cuffless measurement method for measuring blood pressure, there is a method of estimating blood pressure by calculating a Pulse Transit Time (PTT), and a Pulse Wave Analysis (PWA) method of estimating blood pressure by analyzing a pulse wave shape.”).
Regarding claims 3 and 14, Newberry as modified discloses The apparatus of claim 1, Newberry further discloses wherein the processor is further configured to: extract, as the similarity feature, a maximum value of a degree of sameness of a waveform shape between the plurality of beat pulses (FIG. 38 and associated paragraphs showing a normalized and parsed ppg data. The bottom graph in FIG. 38 shows the time difference. See at least para. [0320 – [0322] discussing the phase difference. [0320] discussed difference in graphs according to the wavelength and a shape comparison.).
Regarding claims 5 and 16, Newberry as modified discloses The apparatus of claim 3, Newberry further discloses wherein the processor is further configured to obtain the degree of sameness of the waveform shape based on an area of a waveform of any one of the plurality of beat pulses and a mean absolute error (MAE) between the plurality of beat pulses (FIG. 9B and [0173] discussing area comparisons. See further [0275]. See also FIG. 46 and associated paragraphs, see at least [0367], “FIG. 46 illustrates a graphical representation of a distribution of errors between the predicted glucose levels and the reference glucose levels from FIG. 45. The graph 4600 illustrates Parke's consensus error grid analysis between the predicted glucose levels and the reference glucose levels for the plurality of patients 4602.” Which is interpreted as a MAE.).
Regarding claims 6 and 17, Newberry as modified discloses The apparatus of claim 5, Newberry further discloses wherein the plurality of beat pulses are obtained from a first pulse wave signal of a green light wavelength and a second pulse wave signal of a red light wavelength, among the plurality of pulse wave signals ([0407 -0408] and table 1 discussing wavelengths including at least green and red).
Regarding claim 12, Newberry as modified discloses The apparatus of claim 1,
Newberry fails to disclose wherein the guide information comprises information for inducing the object to gradually increase the contact force applied to the sensor surface or to gradually decrease the contact force from a pressure intensity greater than or equal to a predetermined threshold.
However, in the same field of endeavor, Ishihara teaches wherein the guide information comprises information for inducing the object to gradually increase the contact force applied to the sensor surface or to gradually decrease the contact force from a pressure intensity greater than or equal to a predetermined threshold ([0113], discussing guide information based on contact force and location of sensor, see also [0100] discussing pressing force in relation to blood pressure monitoring to satisfy a condition as claimed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the apparatus/method as taught by Newberry to include wherein the guide information comprises information for inducing the object to gradually increase the contact force applied to the sensor surface or to gradually decrease the contact force from a pressure intensity greater than or equal to a predetermined threshold as taught by Ishihara in order to achieve accurate measurements ([0107], “The attachment state being evaluated as “OK” indicates that the relative positional relationship between the sensor unit 40 and the measurement site is a relationship in which the accuracy of blood pressure measurement based on PTT can be achieved.”).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 5-6, 12-14 and 16-17 have been considered but are moot because the new ground of rejection does not solely rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791