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 .
Applicant' s arguments, filed 11/18/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/18/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 18-21, 23-24, 27-29, 31, 33, 35, 37-39, 42-44, and 46-55 are the currently pending claims hereby under examination. Claims 18. 23, 27, 28, 43, and 50 have been amended.
Claim Objections
Claims 18, 28, and 43 are objected to because of the following informalities:
In claim 18, line 7: "wherein a dynamic pressure map is time series of pressure maps" omits an article and should be revised to "wherein the dynamic pressure map is a time series of pressure maps”;
In claim 28, line 9: ”wherein a dynamic pressure map is time series of pressure maps" omits an article and should be revised to "wherein the dynamic pressure map is a time series of pressure maps”; and
In claim 43, line 8: ”wherein a dynamic pressure map is time series of pressure maps" omits an article and should be revised to "wherein the dynamic pressure map is a time series of pressure maps”.
Appropriate correction is required.
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 18-21, 23-24, 27-29, 31, 33, 35, 37-39, 42-44, and 46-55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 18 recites "a skin surface of a wearer" in lines 3 to 4 and then separately recites "a skin surface of a wearer" in line 8, "a skin surface on a wearer" in line 11, and "a wearer" in line 13. The repeated use of the indefinite article in reciting the skin surface and the wearer makes it unclear whether each recitation refers to the same skin surface and the same wearer or to additional ones. The Examiner is interpreting each such recitation to refer to the same single skin surface of the same single wearer, but the claim language does not compel that reading, and the ambiguity renders the scope of claim 18 unclear under 35 U.S.C. 112(b).
Claim 18 recites "the instantaneous pressure" in lines 12 to 13 ("wherein the intensity value represents the instantaneous pressure from the location on the regions of a skin surface on a wearer"). There is no prior recitation of "an instantaneous pressure" in claim 18 from which "the instantaneous pressure" could draw antecedent basis, the claim reciting only "one or more changes in pressure." Claim 18 therefore lacks proper antecedent basis for "the instantaneous pressure" and is indefinite under 35 U.S.C. 112(b). For purposes of examination, and consistent with the specification (see, for example, paragraphs 48 and 58) and the prior art rejection set forth below, the Examiner interprets "the instantaneous pressure" to mean a pressure value measured at a single point in time at the corresponding location. Appropriate correction, for example reciting "an instantaneous pressure" at its first occurrence or otherwise providing proper antecedent basis, is required.
Claims 19-21, 23-24, and 27 are rejected by virtue of their dependence from claim 18.
Claim 28 recites "a skin surface of the wearer" in line 4 and then separately recites "a skin surface of a wearer" in line 10, "a skin surface on a wearer" in line 13, and "a wearer" in line 15. The repeated use of the indefinite article in reciting the skin surface and the wearer makes it unclear whether each recitation refers to the same skin surface and the same wearer or to additional ones. Claim 28 also recites "the regions of a skin surface" in lines 9 to 10 and in line 13 without previously reciting any "regions" of a skin surface, the claim reciting only "a skin surface of the wearer." There is therefore no antecedent basis for "the regions of a skin surface," and it is unclear whether the claim requires the dynamic pressure map to be acquired from plural discrete regions or from the single skin surface previously recited. The Examiner is interpreting each recitation of the skin surface and the wearer to refer to the same single skin surface of the same single wearer, and is interpreting "the regions of a skin surface" to refer to one or more areas of the previously recited skin surface, but these interpretations are not compelled by the claim language. The ambiguity and missing antecedent basis render claim 28 indefinite under 35 U.S.C. 112(b).
Claim 28 recites "the instantaneous pressure" in lines 14 to 15 ("wherein the intensity value represents the instantaneous pressure from the location on the regions of a skin surface on a wearer"). There is no prior recitation of "an instantaneous pressure" in claim 28 from which "the instantaneous pressure" could draw antecedent basis, the claim reciting only "one or more changes in pressure." Claim 28 therefore lacks proper antecedent basis for "the instantaneous pressure" and is indefinite under 35 U.S.C. 112(b). For purposes of examination, and consistent with the specification and the prior art rejection set forth below, the Examiner interprets "the instantaneous pressure" to mean a pressure value measured at a single point in time at the corresponding location. Appropriate correction is required.
Claims 29, 31, 33, 35, 37-39, and 42 are rejected by virtue of their dependence from claim 28.
Claim 43 recites "a wearer" in line 2, "a skin surface associated with a blood vessel" in line 4, and "the wearer" in line 7 and then separately recites "a skin surface of a wearer" in line 9, "a skin surface on a wearer" in line 12, and "a wearer" in line 14 . The repeated use of the indefinite article in reciting the skin surface and the wearer makes it unclear whether each recitation refers to the same skin surface and the same wearer or to additional ones. Claim 43 also recites "a data processing module configured to generate a dynamic pressure map of the blood vessel" in lines 5 to 6, but then defines the pressure map such that "each pixel corresponds to a location on the regions of a skin surface" in line 12 and "the intensity value represents the instantaneous pressure from the location on the regions of a skin surface" in lines 13 to 14. It is therefore unclear whether the claimed map is a map of the blood vessel or a map of regions of a skin surface. Claim 43 further recites "the regions of a skin surface" without any prior recitation of such regions, the claim reciting only "a skin surface associated with a blood vessel," so that there is no antecedent basis for "the regions of a skin surface." The Examiner is interpreting the dynamic pressure map to be a map of regions of the skin surface overlying the blood vessel, and is interpreting each recitation of the skin surface and the wearer to refer to the same single skin surface of the same single wearer, but these interpretations are not compelled by the claim language. The ambiguity, internal inconsistency, and missing antecedent basis render claim 43 indefinite under 35 U.S.C. 112(b).
Claim 43 recites "the instantaneous pressure" in lines 13 to 14 ("wherein the intensity value represents the instantaneous pressure from the location on the regions of a skin surface on a wearer"). There is no prior recitation of "an instantaneous pressure" in claim 43 from which "the instantaneous pressure" could draw antecedent basis, the claim reciting only "one or more changes in pressure." Claim 43 therefore lacks proper antecedent basis for "the instantaneous pressure" and is indefinite under 35 U.S.C. 112(b). For purposes of examination, and consistent with the specification and the prior art rejection set forth below, the Examiner interprets "the instantaneous pressure" to mean a pressure value measured at a single point in time at the corresponding location.
Claims 44 and 46-55 are rejected by virtue of their dependence from claim 43.
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.
Claims 18-21, 24, 27-29, 31, 33, 35, 37-38, 42-44, 46-52, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita et al. (US 20190046045 A1), hereto referred as Kinoshita, in view of Mehrotra et al. (US 2017/0367596 A1), hereto referred as Mehrotra.
Regarding claim 18, Kinoshita teaches a method of measuring one or more physiological parameters, comprising: measuring one or more changes in pressure on one or more regions of a skin surface of a wearer (Kinoshita, ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown, on a living body portion... in which an artery to be measured for vital information... is present"; Kinoshita, ¶[0036]: "The air bag 2 functions... as a pressing section for pressing a pressing surface 6b of the sensor section 6 against the body surface of a living body portion"; Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave", explaining that Kinoshita measures changes in pressure on the skin surface via contact-based sensing elements).
With respect to generating a dynamic pressure map of the skin surface of the wearer based on the measured one or more changes in pressure of the skin surface, Kinoshita teaches generating and processing spatially resolved, time-varying pressure information from pressure detecting elements positioned at the skin surface. For example, Kinoshita teaches that the sensor section includes an element row 60 including a plurality of pressure detecting elements 6a arranged in a direction B and an element row 70 including a plurality of pressure detecting elements 7a arranged in the direction B (Kinoshita, ¶[0039]). Kinoshita further teaches that each pressure detecting element can detect a pressure vibration wave generated in the radial artery and transmitted to the skin, namely, a pulse wave (Kinoshita, ¶[0042]), and that the control unit calculates vital information based on pressure signals detected in the pulse wave measurement state (Kinoshita, ¶[0070]). Kinoshita also teaches that each pressure signal includes a DC component independent of heart rate and an AC component varied in accordance with the heart rate (Kinoshita, ¶[0082]), that the control unit may divide the pressure signal detected by each pressure detecting element into the AC component and the DC component (Kinoshita, ¶[0088]), that when the DC level of the pressure signal detected by each pressure detecting element is observed, a distribution of pressure can be grasped (Kinoshita, ¶[0138]), and that each curve illustrated in FIG. 11 is formed using DC levels of pressure signals detected by all pressure detecting elements included in the selected element row (Kinoshita, ¶[0141]). Thus, Kinoshita teaches acquiring pressure values from multiple spatially arranged skin-contact pressure detecting elements and processing pressure signals that vary over time.
However, Kinoshita does not expressly teach that the pressure information is generated as the claimed dynamic pressure map, wherein a dynamic pressure map is a time series of pressure maps acquired at successive times from the regions of a skin surface of a wearer; wherein a pressure map is a two-dimensional array of pixels, each pixel having an intensity value; wherein each pixel corresponds to a location on the regions of a skin surface on a wearer; wherein the intensity value represents the instantaneous pressure from the location on the regions of a skin surface on a wearer. Mehrotra teaches these additional features, as discussed below.
For purposes of the prior art rejection, and consistent with the 35 U.S.C. 112(b) rejection set forth separately, the Examiner interprets "the instantaneous pressure" to mean a pressure value measured at a single point in time at the corresponding location. The Examiner further interprets "pixel," in light of the claim language, as an element of the claimed two-dimensional pressure map that corresponds to a skin location and has an intensity value. The claim does not require displaying the dynamic pressure map, storing the pressure map in any particular image file format, or generating a visible graphical pressure image. This interpretation is consistent with the Instant Application, which describes that a raw pressure map is a two-dimensional matrix array of instantaneous pressure values from the pressure sensor (Instant Application, ¶[0048]) and further describes that each pixel may represent the pressure profile at that point on the skin and may represent an individual pressure sensing element (Instant Application, ¶[0058]).
The claimed "pressure map" is not interpreted as requiring a separately rendered image, visual display, or post-processing step that converts the pressure values into a graphical object. Rather, the claim defines the pressure map as a two-dimensional array of pixels, each pixel corresponding to a skin location and having an intensity value representing pressure from that location. Thus, when Mehrotra's two-dimensional pressure sensor array is sampled at a given time and the resulting digital amplitude values are associated with the known two-dimensional locations of the corresponding pressure sensors, that set of location-indexed pressure values forms the claimed pressure map under the claim's own definition.
Mehrotra teaches "blood pressure and other vital sign monitoring using arterial applanation tonometry, including ambulatory blood pressure and other vital sign monitoring" (Mehrotra, Abstract). Mehrotra further teaches measuring blood pressure and other vital sign monitoring "using a plurality of pressure sensors of a pressure sensor array, with one or more of the pressure sensors 140 applanating an artery, such as a radial artery" (Mehrotra, Abstract). Mehrotra also teaches a wearable wristband embodiment in which "FIG. 1 is a plan view diagram illustrating representative first and/or second apparatus 100, 300 embodiments with a wearable wristband attachment attached to a wrist 50 of an individual subject" and "FIG. 2 is a cross-sectional view... with applanation of a radial artery 60" (Mehrotra, ¶[0056]). Mehrotra teaches that "one or more pressure sensors 140 of the pressure sensor array 110... is arranged or positioned substantially over the artery 60 to detect and/or measure pressure from the applanated artery 60 and the surrounding tissue," while other pressure sensors may be positioned medially or laterally from the applanated artery (Mehrotra, ¶[0057]). Mehrotra further teaches using "a pressure sensor array having a plurality of pressure sensors spaced-apart in at least two dimensions" for applanating an artery and receiving plural pressure sensor signals having data representing amplitudes of arterial pressure waves (Mehrotra, ¶[0012]; see also Mehrotra, Fig. 5).
Mehrotra further teaches that the pressure sensor signals are sampled and converted into digital values over time. Specifically, Mehrotra teaches that "the analog-to-digital converter (ADC) 115 samples the analog pressure sensor signals from each of the pressure sensors 140 of the pressure sensor array 110 and generates a stream or series of corresponding digital amplitude values, each of which is indicative of or represents the amplitude of one or more arterial pressure waves occurring during the sampling time interval" (Mehrotra, ¶[0060]). Mehrotra also teaches that the stream or series of digital amplitude values is combined "from each pressure sensor 140 of the pressure sensor array 110" and transmitted for processing (Mehrotra, ¶[0061]). Mehrotra further teaches that the pressure sensors generate signals "which are continually sampled and converted to corresponding digital amplitude values indicative of or representing the arterial pressure waves" and that the method may iterate while "shifting a time window for examining the incoming digital data values" (Mehrotra, ¶[0078]). Mehrotra similarly teaches that "as each of the pressure sensors 140 generate a corresponding pressure sensor 140 signal, the pressure sensor 140 signals are sampled... and converted to corresponding digital amplitude values... such as using an ADC 115" (Mehrotra, ¶[0079]).
Mehrotra additionally confirms that the spatial relationships of the pressure sensor signals are used because the processor determines cross-coherence with nearest-neighbor pressure sensor signals before selecting a pressure sensor signal (Mehrotra, ¶[0013]: "for each periodic pressure sensor signal of the second plurality of selected pressure sensor signals, determining a cross-coherence with each nearest neighbor pressure sensor signal"; Mehrotra, ¶[0022]: the processor may determine cross-coherence with each nearest neighbor pressure sensor signal and select a periodic pressure sensor signal having a highest mean cross-coherence; see also Mehrotra, Fig. 6B).
Accordingly, Mehrotra teaches the claimed dynamic pressure map as interpreted above. Mehrotra teaches that pressure sensor signals from each pressure sensor of a two-dimensional pressure sensor array are continually sampled and converted into a stream or series of digital amplitude values at sampling time intervals. At each sampling time, arranging the digital amplitude values according to the known two-dimensional locations of the corresponding pressure sensors forms a pressure map. Each pressure-map element corresponding to a pressure sensor position in the two-dimensional array corresponds to a skin location, and the corresponding digital amplitude value is an intensity value representing a pressure value measured at that location at that sampling time. The sampling interval is the discretization period by which the pressure value is acquired and digitized, and does not change the fact that each sample represents the pressure value at the corresponding sensor location for the associated sampling time. The successive sampled sets of digital amplitude values form the claimed dynamic pressure map.
This reading is consistent with the Examiner's 35 U.S.C. 112(b) interpretation of "the instantaneous pressure" as a pressure value measured at a single point in time at the corresponding location. Under that interpretation, Mehrotra's per-sensor digital amplitude value at a given sampling time reads on the claimed intensity value representing the instantaneous pressure from the corresponding location.
The rejection is not dependent on whether the pressure value is characterized as a DC contact-pressure value or an AC pulsatile pressure-wave value. Kinoshita teaches pressure signals having DC and AC components and teaches using DC levels detected by pressure detecting elements to grasp a pressure distribution, while Mehrotra teaches sampling pressure sensor signals from a two-dimensional pressure sensor array and converting the signals into digital amplitude values over time. Accordingly, both spatial contact-pressure distribution information and pulsatile pressure-wave amplitude information are taught by the applied art.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kinoshita to use the two-dimensional pressure sensor array and sampled digital amplitude value processing taught by Mehrotra, such that the pressure changes measured at the skin surface are acquired as a time series of pressure maps formed by pressure values at respective pressure sensor locations. Both Kinoshita and Mehrotra are directed to non-invasive, wrist-worn arterial pressure or pulse wave sensing for determining blood pressure and other physiological information from pressure signals detected at the skin over an artery. The modification would have involved applying Mehrotra's known two-dimensional force sensor array and sampled digital pressure-amplitude processing to Kinoshita's wrist-worn pressure sensing method to improve spatial pressure sensing over the artery and to more reliably obtain usable pressure waveform data.
One of ordinary skill in the art would have had a reasonable expectation of success in making the modification because both Kinoshita and Mehrotra use pressure sensors positioned at the skin over an artery to obtain pressure signals for determining blood pressure or other vital information. Kinoshita already includes a control unit for processing pressure signals from pressure detecting elements, and Mehrotra teaches sampling pressure sensor signals with an analog-to-digital converter and processing the resulting digital amplitude values. Thus, applying Mehrotra's two-dimensional pressure sensor array and digital sampling approach to Kinoshita's wrist-worn pressure sensing method would have involved using known pressure-sensing and digital-signal-processing components according to their known functions.
One of ordinary skill in the art would have been motivated to make the modification because Mehrotra teaches that "[t]he two-dimensional array of pressure sensors increases the likelihood of obtaining accurate pressure sensor data from an applanated artery" and that the approach is "particularly advantageous in an ambulatory setting, where it may be difficult to locate an individual's artery, and the signals generated may be noisy" (Mehrotra, ¶[0011]). Thus, the modification would have predictably improved Kinoshita's wrist-worn pressure-based vital information measurement by increasing the likelihood of obtaining accurate pressure data from the artery despite placement variability and noise. The modification would have been no more than the use of a known pressure sensor array and known digital sampling technique to improve a similar wrist-worn pressure-based arterial measurement method in the same way.
Therefore, the modified Kinoshita teaches the method of claim 18, including measuring pressure changes on regions of a skin surface of a wearer and generating, from a two-dimensional pressure sensor array sampled at successive times, a dynamic pressure map in which each map element corresponds to a skin location and has a digital amplitude value representing instantaneous pressure from that location.
Regarding claim 19, the modified Kinoshita teaches that the measuring one or more changes in pressure on the skin surface of the wearer further comprises measuring physiological reaction forces on the skin surface of the wearer (Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave", explaining that the sensor detects physiological forces such as pulse waves transferred to the skin surface; ¶[0003]: "...measuring vital information such as the pulse, the heart rate or the blood pressure using information detected by a pressure sensor set in contact with a surface of a living body portion", supporting that the sensor measures physiological forces interacting with the skin).
Regarding claim 20, the modified Kinoshita teaches that the physiological reaction forces are oscillometric pressure waves generated by a blood vessel proximal to the skin surface of the wearer (Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave", explaining that the physiological force being measured is a pressure wave, such as those used in oscillometric blood pressure measurement, originating from a blood vessel near the skin surface, which is implicitly or inherently oscillometric).
Regarding claim 21, the modified Kinoshita teaches that the method further comprises determining a location of a blood vessel proximal to the skin surface of the wearer (Kinoshita, Figs. 1, 10A–C; ¶[0141]: "Each curve illustrated in FIG. 11 is formed by using DC levels of pressure signals detected by all the pressure detecting elements included in the selected element row", showing that location-specific signal profiles are used to detect features such as arteries; ¶[0138]: "...a distribution of the pressure from a hard tissue such as a bone or a tendon can be grasped", indicating that spatial analysis of sensor data is used to infer anatomical structure location including blood vessels; ¶[0087]: "a target element (hereinafter referred to as the first target element) corresponding to one pressure detecting element positioned above the radial artery T out of all the pressure detecting elements 6 a...", showing that specific sensor elements, designated as target elements, are selected based on physiological signal characteristics, thereby identifying locations associated with blood vessels).
Regarding claim 24, the modified Kinoshita teaches that the method further comprises: occluding the blood vessel; and calibrating the one or more measured pressure changes of the skin surface (Kinoshita, ¶[0034]: "The air pump 10 is an example of a pressurizing section that supplies air to the air bag 2 to cause the air bag 2 to expand, whereby the pressing surface 6b is pressed against the skin surface...", showing that the air bag is used to apply pressure to the skin; ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmax) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", explicitly stating that the pressing force corresponds to occlusion completion and is used to calibrate the pressure response; ¶[0054]: "Further, based on the MBP, a maximum value of a rising slope and a maximum value of a falling slope of the pulse wave are calculated. A systolic blood pressure and a diastolic blood pressure are estimated based on the MBP and the maximum values...", confirming that the pressure waveforms obtained during occlusion are used to calibrate and estimate physiological pressures).
Regarding claim 27, the modified Kinoshita teaches that the method further comprises determining one or more physiological parameters of the wearer based on the measured one or more changes in pressure of the skin surface, wherein the one or more physiological parameters comprise a systolic blood pressure, a diastolic blood pressure, a mean blood pressure, a heart rate, a blood vessel viscoelasticity, an arterial stiffness, or a combination thereof (Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15", teaching that physiological parameters are computed from pressure signals; ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", expressly disclosing the determination of systolic blood pressure, diastolic blood pressure, and heart rate from pulse waveforms).
Regarding claim 28, Kinoshita teaches a wearable physiological measurement device, comprising: a support configured to engage a portion of a limb of a wearer (Kinoshita, Fig. 1; Kinoshita, ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown, on a living body portion... in which an artery to be measured for vital information... is present"; Kinoshita, ¶[0038]: "In the worn state illustrated in FIG. 1, the pressing surface 6b of the sensor section 6 included in the pulse wave detection unit 100 is in contact with the skin of the wrist of the user"); a sensor array coupled to the support and configured to sense one or more pressure changes on a skin surface of the wearer (Kinoshita, Fig. 1; Kinoshita, ¶[0039]: "the sensor section 6 includes an element row 60 including a plurality of pressure detecting elements 6a... and an element row 70 including a plurality of pressure detecting elements 7a..."; Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin", showing that the sensor array senses pressure changes on the skin surface of the wearer); and a data processing module (Kinoshita, ¶[0063]: "The control unit 12 mainly includes a processor, and includes a ROM (read only memory) storing programs"; Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15").
Kinoshita further teaches that the control unit processes pressure information from the pressure detecting elements. For example, Kinoshita teaches that the control unit calculates vital information based on pressure signals detected in the pulse wave measurement state (Kinoshita, ¶[0070]). Kinoshita further teaches that each pressure signal includes a DC component independent of heart rate and an AC component varied in accordance with the heart rate (Kinoshita, ¶[0082]), that the control unit may divide the pressure signal detected by each pressure detecting element into the AC component and the DC component (Kinoshita, ¶[0088]), that when the DC level of the pressure signal detected by each pressure detecting element is observed, a distribution of pressure can be grasped (Kinoshita, ¶[0138]), and that each curve illustrated in FIG. 11 is formed using DC levels of pressure signals detected by all pressure detecting elements included in the selected element row (Kinoshita, ¶[0141]). Thus, Kinoshita teaches a data processing module that processes spatially resolved, time-varying pressure information from multiple skin-contact pressure detecting elements.
However, Kinoshita does not expressly teach that the data processing module is configured to generate the claimed dynamic pressure map of the skin surface based on the one or more sensed pressure changes on the skin surface, wherein one or more physiological parameters of the wearer are derived from the dynamic pressure map, and wherein a dynamic pressure map is a time series of pressure maps acquired at successive times from the regions of a skin surface of a wearer; wherein a pressure map is a two-dimensional array of pixels, each pixel having an intensity value; wherein each pixel corresponds to a location on the regions of a skin surface on a wearer; wherein the intensity value represents the instantaneous pressure from the location on the regions of a skin surface on a wearer. In particular, Kinoshita does not expressly teach acquiring the pressure information from the sensor array as a time series of pressure maps in which each pressure map is a two-dimensional array of pixels having intensity values corresponding to instantaneous pressure values at respective skin locations. Mehrotra teaches these additional features. As modified by Mehrotra, the sensor array of Kinoshita is implemented as Mehrotra's two-dimensional pressure sensor array having pressure sensors spaced apart in at least two dimensions.
For purposes of the prior art rejection, and consistent with the 35 U.S.C. 112(b) rejection set forth separately, the Examiner interprets "the instantaneous pressure" to mean a pressure value measured at a single point in time at the corresponding location. The Examiner further interprets "pixel," in light of the claim language, as an element of the claimed two-dimensional pressure map that corresponds to a skin location and has an intensity value. The claim does not require displaying the dynamic pressure map, storing the pressure map in any particular image file format, or generating a visible graphical pressure image. This interpretation is consistent with the Instant Application, which describes that a raw pressure map is a two-dimensional matrix array of instantaneous pressure values from the pressure sensor (Instant Application, ¶[0048]) and further describes that each pixel may represent the pressure profile at that point on the skin and may represent an individual pressure sensing element (Instant Application, ¶[0058]).
Mehrotra teaches "blood pressure and other vital sign monitoring using arterial applanation tonometry, including ambulatory blood pressure and other vital sign monitoring" (Mehrotra, Abstract). Mehrotra further teaches measuring blood pressure and other vital sign monitoring "using a plurality of pressure sensors of a pressure sensor array, with one or more of the pressure sensors 140 applanating an artery, such as a radial artery" (Mehrotra, Abstract). Mehrotra also teaches a wearable wristband embodiment in which "FIG. 1 is a plan view diagram illustrating representative first and/or second apparatus 100, 300 embodiments with a wearable wristband attachment attached to a wrist 50 of an individual subject" and "FIG. 2 is a cross-sectional view... with applanation of a radial artery 60" (Mehrotra, ¶[0056]). Mehrotra teaches that "one or more pressure sensors 140 of the pressure sensor array 110... is arranged or positioned substantially over the artery 60 to detect and/or measure pressure from the applanated artery 60 and the surrounding tissue," while other pressure sensors may be positioned medially or laterally from the applanated artery (Mehrotra, ¶[0057]). Mehrotra further teaches using "a pressure sensor array having a plurality of pressure sensors spaced-apart in at least two dimensions" for applanating an artery and receiving plural pressure sensor signals having data representing amplitudes of arterial pressure waves (Mehrotra, ¶[0012]; see also Mehrotra, Fig. 5).
Mehrotra further teaches that the pressure sensor signals are sampled and converted into digital values over time. Specifically, Mehrotra teaches that "the analog-to-digital converter (ADC) 115 samples the analog pressure sensor signals from each of the pressure sensors 140 of the pressure sensor array 110 and generates a stream or series of corresponding digital amplitude values, each of which is indicative of or represents the amplitude of one or more arterial pressure waves occurring during the sampling time interval" (Mehrotra, ¶[0060]). Mehrotra also teaches that the stream or series of digital amplitude values is combined "from each pressure sensor 140 of the pressure sensor array 110" and transmitted for processing (Mehrotra, ¶[0061]). Mehrotra further teaches that the pressure sensors generate signals "which are continually sampled and converted to corresponding digital amplitude values indicative of or representing the arterial pressure waves" and that the method may iterate while "shifting a time window for examining the incoming digital data values" (Mehrotra, ¶[0078]). Mehrotra similarly teaches that "as each of the pressure sensors 140 generate a corresponding pressure sensor 140 signal, the pressure sensor 140 signals are sampled... and converted to corresponding digital amplitude values... such as using an ADC 115" (Mehrotra, ¶[0079]).
Mehrotra additionally confirms that the spatial relationships of the pressure sensor signals are used because the processor determines cross-coherence with nearest-neighbor pressure sensor signals before selecting a pressure sensor signal (Mehrotra, ¶[0013]: "for each periodic pressure sensor signal of the second plurality of selected pressure sensor signals, determining a cross-coherence with each nearest neighbor pressure sensor signal"; Mehrotra, ¶[0022]: the processor may determine cross-coherence with each nearest neighbor pressure sensor signal and select a periodic pressure sensor signal having a highest mean cross-coherence; see also Mehrotra, Fig. 6B).
Accordingly, Mehrotra teaches generating a time series of pressure maps acquired at successive times from the regions of a skin surface of a wearer. Mehrotra's pressure sensor signals from each pressure sensor of a two-dimensional pressure sensor array are continually sampled and converted into a stream or series of digital amplitude values at sampling time intervals. At each sampling time, arranging the digital amplitude values according to the known two-dimensional locations of the corresponding pressure sensors forms a pressure map. Each pressure-map element corresponding to a pressure sensor position in the two-dimensional array corresponds to a skin location, and the corresponding digital amplitude value is an intensity value representing a pressure value measured at that location at that sampling time. The sampling interval is the discretization period by which the pressure value is acquired and digitized, and does not change the fact that each sample represents the pressure value at the corresponding sensor location for the associated sampling time. The successive sampled sets of digital amplitude values form the claimed dynamic pressure map.
This reading is consistent with the Examiner's 35 U.S.C. 112(b) interpretation of "the instantaneous pressure" as a pressure value measured at a single point in time at the corresponding location. Under that interpretation, Mehrotra's per-sensor digital amplitude value at a given sampling time reads on the claimed intensity value representing the instantaneous pressure from the corresponding location.
The claimed "pressure map" is not interpreted as requiring a separately rendered image, visual display, or post-processing step that converts the pressure values into a graphical object. Rather, the claim defines the pressure map as a two-dimensional array of pixels, each pixel corresponding to a skin location and having an intensity value representing pressure from that location. Thus, when Mehrotra's two-dimensional pressure sensor array is sampled at a given time and the resulting digital amplitude values are associated with the known two-dimensional locations of the corresponding pressure sensors, that set of location-indexed pressure values forms the claimed pressure map under the claim's own definition.
The rejection is not dependent on whether the pressure value is characterized as a DC contact-pressure value or an AC pulsatile pressure-wave value. Kinoshita teaches pressure signals having DC and AC components and teaches using DC levels detected by pressure detecting elements to grasp a pressure distribution, while Mehrotra teaches sampling pressure sensor signals from a two-dimensional pressure sensor array and converting the signals into digital amplitude values over time. Accordingly, both spatial contact-pressure distribution information and pulsatile pressure-wave amplitude information are taught by the applied art.
Kinoshita further teaches deriving physiological parameters from pressure signals detected by the pressure detecting elements (Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15"; Kinoshita, ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate"). Kinoshita does not expressly teach that the physiological parameters are derived from the pressure signals as arranged in the claimed dynamic pressure map. However, as discussed above, Mehrotra teaches acquiring the pressure signals from a two-dimensional pressure sensor array as successive sets of sampled digital amplitude values arranged according to the known two-dimensional pressure sensor locations. Thus, in the modified Kinoshita device, the pressure signals used to derive the physiological parameters are acquired as the claimed dynamic pressure map, and the physiological parameters are derived from the dynamic pressure map.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kinoshita to use the two-dimensional pressure sensor array and sampled digital amplitude value processing taught by Mehrotra, such that the pressure changes measured at the skin surface are acquired as a time series of pressure maps formed by pressure values at respective pressure sensor locations. Both Kinoshita and Mehrotra are directed to non-invasive, wrist-worn arterial pressure or pulse wave sensing for determining blood pressure and other physiological information from pressure signals detected at the skin over an artery. The modification would have involved applying Mehrotra's known two-dimensional force sensor array and sampled digital pressure-amplitude processing to Kinoshita's wrist-worn pressure sensing device to improve spatial pressure sensing over the artery and to more reliably obtain usable pressure waveform data.
One of ordinary skill in the art would have had a reasonable expectation of success in making the modification because both Kinoshita and Mehrotra use pressure sensors positioned at the skin over an artery to obtain pressure signals for determining blood pressure or other vital information. Kinoshita already includes a control unit for processing pressure signals from pressure detecting elements, and Mehrotra teaches sampling pressure sensor signals with an analog-to-digital converter and processing the resulting digital amplitude values. Thus, applying Mehrotra's two-dimensional pressure sensor array and digital sampling approach to Kinoshita's wrist-worn pressure sensing device would have involved using known pressure-sensing and digital-signal-processing components according to their known functions.
One of ordinary skill in the art would have been motivated to make the modification because Mehrotra teaches that "[t]he two-dimensional array of pressure sensors increases the likelihood of obtaining accurate pressure sensor data from an applanated artery" and that the approach is "particularly advantageous in an ambulatory setting, where it may be difficult to locate an individual's artery, and the signals generated may be noisy" (Mehrotra, ¶[0011]). Thus, the modification would have predictably improved Kinoshita's wrist-worn pressure-based vital information measurement by increasing the likelihood of obtaining accurate pressure data from the artery despite placement variability and noise. The modification would have been no more than the use of a known pressure sensor array and known digital sampling technique to improve a similar wrist-worn pressure-based arterial measurement device in the same way.
Regarding claim 29, the modified Kinoshita teaches that the data processing module is configured to transmit the dynamic pressure map to a biometric display unit (Kinoshita, Fig. ¶[0072]: “In this case, the pressure signals stored in the memory 15 of the vital information measuring device are transmitted to the electronic equipment, and vital information is calculated and stored in the electronic equipment”, showing that pressure signal data from which a dynamic pressure map is generated is transmitted for processing and display; ¶[0076]: “The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13”, ¶[0060]: "The display section 13 is used for displaying various information including vital information, and includes, for example, a liquid crystal display", confirming that the device transmits derived pressure-based data to an onboard display unit).
Regarding claim 31, the modified Kinoshita teaches that at least one of the one or more sensed pressure changes is associated with one or more physiological parameters of a blood vessel proximal to the skin surface of the wearer (Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin, namely, a pulse wave, when pressed against the radial artery T in such a manner that the arrangement direction crosses the radial artery T (at substantially right angles)", showing that the pressure signals sensed by the device correspond to a blood vessel beneath the skin; ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15", teaching that physiological parameters are computed from pressure signals; ¶[0071]: "The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", showing that the sensed pressure signals are used to determine physiological parameters of the underlying vessel).
Regarding claim 33, the modified Kinoshita teaches that the support is configurable in a configuration of either: a non-occlusion configuration; or an occlusion configuration for occluding the blood vessel (Kinoshita, ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level of the target element... has reached the occlusion completion determination threshold value", showing that the device enters an occlusion configuration by applying a specific pressing force sufficient to complete occlusion; ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", demonstrating a controlled transition into an occlusion configuration via pressure adjustment from a non-occluded state; ¶[0206]: "The state where the radial artery T is appropriately pressed refers to a state where the radial artery T is not occluded... namely, what is called a tonometry state", showing that in continuous measurement mode the support remains in a non-occlusion configuration).
Regarding claim 35, the modified Kinoshita teaches that a mechanism to change the configuration of the support comprises an actuator mechanism, a mechanical actuation mechanism, a fluid actuation mechanism, or a combination thereof (Kinoshita, ¶[0059]: "The air bag drive section 11 includes a pump or the like, and controls the amount of air injected into the air bag 2 (the internal pressure of the air bag 2) in accordance with an instruction issued by the control unit 12", showing that a fluid actuation mechanism (air pump) changes the support's configuration for pressure application; ¶[0058]: "The rotation drive section 10 is an actuator for driving the biaxial rotation mechanism 5a of the pulse wave detection unit 100", showing that a mechanical actuation mechanism is also used to reposition the support structure).
Regarding claim 37, the modified Kinoshita teaches that the device is operable in a calibration mode, and wherein operation in the calibration mode configures the support in the occlusion configuration for calibrating baseline parameters for the one or more physiological parameters (Kinoshita, ¶[0188]–[0197]: “the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T”, “the control unit 12 generates pulse wave envelope data based on the pressure signals detected by the pressure detecting elements”, and “the control unit 12 holds the pressing force at the optimal pressing force... [and] calculates the SBP and the DBP based on the thus generated pulse wave envelope data, and generates the correction data”, showing that the device enters an occlusion configuration during calibration mode and uses pressure signals collected under that condition to calibrate baseline parameters including systolic and diastolic blood pressure; Figs. 7–8: Figure 7 shows the procedure for selecting the element row and setting first and second pressing values, demonstrating how calibration mode defines specific force thresholds associated with occlusion; Figure 8 illustrates the change in pressing force and corresponding AC signal during measurement, visually showing how the system reaches and holds an occlusion-level force to generate calibration data for vital sign determination).
Regarding claim 38, the modified Kinoshita teaches that the device is operable in a calibration mode, and wherein operation in the calibration mode configures the support in the occlusion configuration for monitoring the one or more physiological parameters (Kinoshita, ¶[0076]: "The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13", showing that the device calculates systolic and diastolic blood pressure values repeatedly during operation, confirming that physiological parameters are monitored during the same occlusion-based calibration mode described in ¶[0188]–[0197] and Figs. 7-8, as shown in claim 37 above).
Regarding claim 42, the modified Kinoshita teaches that the one or more physiological parameters comprise a systolic blood pressure, a diastolic blood pressure, a mean blood pressure, a heart rate, a blood vessel viscoelasticity, an arterial stiffness, or a combination thereof (Kinoshita, ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", showing that Kinoshita discloses systolic pressure, diastolic pressure, and heart rate).
Regarding claim 43, Kinoshita teaches a wearable blood pressure measurement device, comprising: a sleeve configured to engage a portion of a limb of a wearer (Kinoshita, Fig. 1; Kinoshita, ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown, on a living body portion... in which an artery to be measured for vital information... is present"; Kinoshita, ¶[0003]: "measuring vital information such as the pulse, the heart rate or the blood pressure", showing that the device is used to measure blood pressure). The Examiner interprets "sleeve" under the broadest reasonable interpretation to encompass a wearable structure that engages a portion of a limb and supports the sensor array relative to the limb, and does not interpret "sleeve" as requiring a fully tubular garment. This interpretation is consistent with the Instant Application, which describes the sleeve as a support worn on a limb and separately recites additional effective-diameter and occlusion features in particular embodiments. Under this interpretation, Kinoshita's band worn on the wrist to position the pulse wave detection unit on the living body portion teaches the claimed sleeve. This interpretation is also consistent with Mehrotra, which teaches a wearable wristband attachment attached to a wrist of an individual subject (Mehrotra, ¶[0056]); a sensor array coupled to the sleeve and configured to sense one or more changes in pressure on a skin surface associated with a blood vessel (Kinoshita, Fig. 1; Kinoshita, ¶[0038]: "In the worn state illustrated in FIG. 1, the pressing surface 6b of the sensor section 6 included in the pulse wave detection unit 100 is in contact with the skin of the wrist of the user"; Kinoshita, ¶[0039]: "the sensor section 6 includes an element row 60 including a plurality of pressure detecting elements 6a... and an element row 70 including a plurality of pressure detecting elements 7a..."; Kinoshita, ¶[0042]: "Each of the pressure detecting elements 6a (7a) can detect a pressure vibration wave generated in the radial artery T and transmitted to the skin", showing that the sensor array is coupled to the wearable sleeve or band and senses pressure changes on a skin surface associated with a blood vessel); and a data processing module (Kinoshita, ¶[0063]: "The control unit 12 mainly includes a processor, and includes a ROM (read only memory) storing programs"; Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15").
Kinoshita further teaches that the control unit processes pressure information from the pressure detecting elements. For example, Kinoshita teaches that the control unit calculates vital information based on pressure signals detected in the pulse wave measurement state (Kinoshita, ¶[0070]). Kinoshita further teaches that each pressure signal includes a DC component independent of heart rate and an AC component varied in accordance with the heart rate (Kinoshita, ¶[0082]), that the control unit may divide the pressure signal detected by each pressure detecting element into the AC component and the DC component (Kinoshita, ¶[0088]), that when the DC level of the pressure signal detected by each pressure detecting element is observed, a distribution of pressure can be grasped (Kinoshita, ¶[0138]), and that each curve illustrated in FIG. 11 is formed using DC levels of pressure signals detected by all pressure detecting elements included in the selected element row (Kinoshita, ¶[0141]). Thus, Kinoshita teaches a data processing module that processes spatially resolved, time-varying pressure information from multiple skin-contact pressure detecting elements.
However, Kinoshita does not expressly teach that the data processing module is configured to generate the claimed dynamic pressure map of the blood vessel based on the one or more sensed pressure changes, wherein a blood pressure of the wearer is determined from the dynamic pressure map, and wherein a dynamic pressure map is a time series of pressure maps acquired at successive times from the regions of a skin surface of a wearer; wherein a pressure map is a two-dimensional array of pixels, each pixel having an intensity value; wherein each pixel corresponds to a location on the regions of a skin surface on a wearer; wherein the intensity value represents the instantaneous pressure from the location on the regions of a skin surface on a wearer. In particular, Kinoshita does not expressly teach acquiring the pressure information from the sensor array as a time series of pressure maps in which each pressure map is a two-dimensional array of pixels having intensity values corresponding to instantaneous pressure values at respective skin locations. Mehrotra teaches these additional features. As modified by Mehrotra, the sensor array of Kinoshita is implemented as Mehrotra's two-dimensional pressure sensor array having pressure sensors spaced apart in at least two dimensions.
For purposes of the prior art rejection, and consistent with the 35 U.S.C. 112(b) rejection set forth separately, the Examiner interprets the claimed "dynamic pressure map of the blood vessel" to mean a dynamic pressure map of regions of the skin surface overlying or associated with the blood vessel. The Examiner interprets "the instantaneous pressure" to mean a pressure value measured at a single point in time at the corresponding location. The Examiner further interprets "pixel," in light of the claim language, as an element of the claimed two-dimensional pressure map that corresponds to a skin location and has an intensity value. The claim does not require displaying the dynamic pressure map, storing the pressure map in any particular image file format, or generating a visible graphical pressure image. This interpretation is consistent with the Instant Application, which describes that a raw pressure map is a two-dimensional matrix array of instantaneous pressure values from the pressure sensor (Instant Application, ¶[0048]) and further describes that each pixel may represent the pressure profile at that point on the skin and may represent an individual pressure sensing element (Instant Application, ¶[0058]).
Mehrotra teaches "blood pressure and other vital sign monitoring using arterial applanation tonometry, including ambulatory blood pressure and other vital sign monitoring" (Mehrotra, Abstract). Mehrotra further teaches measuring blood pressure and other vital sign monitoring "using a plurality of pressure sensors of a pressure sensor array, with one or more of the pressure sensors 140 applanating an artery, such as a radial artery" (Mehrotra, Abstract). Mehrotra also teaches a wearable wristband embodiment in which "FIG. 1 is a plan view diagram illustrating representative first and/or second apparatus 100, 300 embodiments with a wearable wristband attachment attached to a wrist 50 of an individual subject" and "FIG. 2 is a cross-sectional view... with applanation of a radial artery 60" (Mehrotra, ¶[0056]). Mehrotra teaches that "one or more pressure sensors 140 of the pressure sensor array 110... is arranged or positioned substantially over the artery 60 to detect and/or measure pressure from the applanated artery 60 and the surrounding tissue," while other pressure sensors may be positioned medially or laterally from the applanated artery (Mehrotra, ¶[0057]). Mehrotra further teaches using "a pressure sensor array having a plurality of pressure sensors spaced-apart in at least two dimensions" for applanating an artery and receiving plural pressure sensor signals having data representing amplitudes of arterial pressure waves (Mehrotra, ¶[0012]; see also Mehrotra, Fig. 5).
Mehrotra further teaches that the pressure sensor signals are sampled and converted into digital values over time. Specifically, Mehrotra teaches that "the analog-to-digital converter (ADC) 115 samples the analog pressure sensor signals from each of the pressure sensors 140 of the pressure sensor array 110 and generates a stream or series of corresponding digital amplitude values, each of which is indicative of or represents the amplitude of one or more arterial pressure waves occurring during the sampling time interval" (Mehrotra, ¶[0060]). Mehrotra also teaches that the stream or series of digital amplitude values is combined "from each pressure sensor 140 of the pressure sensor array 110" and transmitted for processing (Mehrotra, ¶[0061]). Mehrotra further teaches that the pressure sensors generate signals "which are continually sampled and converted to corresponding digital amplitude values indicative of or representing the arterial pressure waves" and that the method may iterate while "shifting a time window for examining the incoming digital data values" (Mehrotra, ¶[0078]). Mehrotra similarly teaches that "as each of the pressure sensors 140 generate a corresponding pressure sensor 140 signal, the pressure sensor 140 signals are sampled... and converted to corresponding digital amplitude values... such as using an ADC 115" (Mehrotra, ¶[0079]).
Mehrotra additionally confirms that the spatial relationships of the pressure sensor signals are used because the processor determines cross-coherence with nearest-neighbor pressure sensor signals before selecting a pressure sensor signal (Mehrotra, ¶[0013]: "for each periodic pressure sensor signal of the second plurality of selected pressure sensor signals, determining a cross-coherence with each nearest neighbor pressure sensor signal"; Mehrotra, ¶[0022]: the processor may determine cross-coherence with each nearest neighbor pressure sensor signal and select a periodic pressure sensor signal having a highest mean cross-coherence; see also Mehrotra, Fig. 6B).
Accordingly, Mehrotra teaches generating a time series of pressure maps acquired at successive times from the regions of a skin surface of a wearer. Mehrotra's pressure sensor signals from each pressure sensor of a two-dimensional pressure sensor array are continually sampled and converted into a stream or series of digital amplitude values at sampling time intervals. At each sampling time, arranging the digital amplitude values according to the known two-dimensional locations of the corresponding pressure sensors forms a pressure map. Each pressure-map element corresponding to a pressure sensor position in the two-dimensional array corresponds to a skin location, and the corresponding digital amplitude value is an intensity value representing a pressure value measured at that location at that sampling time. The sampling interval is the discretization period by which the pressure value is acquired and digitized, and does not change the fact that each sample represents the pressure value at the corresponding sensor location for the associated sampling time. The successive sampled sets of digital amplitude values form the claimed dynamic pressure map.
This reading is consistent with the Examiner's 35 U.S.C. 112(b) interpretation of "the instantaneous pressure" as a pressure value measured at a single point in time at the corresponding location. Under that interpretation, Mehrotra's per-sensor digital amplitude value at a given sampling time reads on the claimed intensity value representing the instantaneous pressure from the corresponding location.
The claimed "pressure map" is not interpreted as requiring a separately rendered image, visual display, or post-processing step that converts the pressure values into a graphical object. Rather, the claim defines the pressure map as a two-dimensional array of pixels, each pixel corresponding to a skin location and having an intensity value representing pressure from that location. Thus, when Mehrotra's two-dimensional pressure sensor array is sampled at a given time and the resulting digital amplitude values are associated with the known two-dimensional locations of the corresponding pressure sensors, that set of location-indexed pressure values forms the claimed pressure map under the claim's own definition.
The rejection is not dependent on whether the pressure value is characterized as a DC contact-pressure value or an AC pulsatile pressure-wave value. Kinoshita teaches pressure signals having DC and AC components and teaches using DC levels detected by pressure detecting elements to grasp a pressure distribution, while Mehrotra teaches sampling pressure sensor signals from a two-dimensional pressure sensor array and converting the signals into digital amplitude values over time. Accordingly, both spatial contact-pressure distribution information and pulsatile pressure-wave amplitude information are taught by the applied art.
Kinoshita further teaches determining blood pressure from pressure signals detected by the pressure detecting elements (Kinoshita, ¶[0070]: "The control unit 12 calculates vital information based on pressure signals detected in the pulse wave measurement state and stored in the memory 15, and stores the calculated vital information in the memory 15"; Kinoshita, ¶[0071]: "The vital information may be any information as long as it can be calculated based on a pulse wave. The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate"). Kinoshita does not expressly teach that the blood pressure is determined from the pressure signals as arranged in the claimed dynamic pressure map. However, as discussed above, Mehrotra teaches acquiring the pressure signals from a two-dimensional pressure sensor array as successive sets of sampled digital amplitude values arranged according to the known two-dimensional pressure sensor locations. Thus, in the modified Kinoshita device, the pressure signals used to determine blood pressure are acquired as the claimed dynamic pressure map, and the blood pressure is determined from the dynamic pressure map.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kinoshita to use the two-dimensional pressure sensor array and sampled digital amplitude value processing taught by Mehrotra, such that the pressure changes measured at the skin surface associated with the blood vessel are acquired as a time series of pressure maps formed by pressure values at respective pressure sensor locations. Both Kinoshita and Mehrotra are directed to non-invasive, wrist-worn arterial pressure or pulse wave sensing for determining blood pressure and other physiological information from pressure signals detected at the skin over an artery. The modification would have involved applying Mehrotra's known two-dimensional force sensor array and sampled digital pressure-amplitude processing to Kinoshita's wrist-worn pressure sensing device to improve spatial pressure sensing over the artery and to more reliably obtain usable pressure waveform data.
One of ordinary skill in the art would have had a reasonable expectation of success in making the modification because both Kinoshita and Mehrotra use pressure sensors positioned at the skin over an artery to obtain pressure signals for determining blood pressure or other vital information. Kinoshita already includes a control unit for processing pressure signals from pressure detecting elements, and Mehrotra teaches sampling pressure sensor signals with an analog-to-digital converter and processing the resulting digital amplitude values. Thus, applying Mehrotra's two-dimensional pressure sensor array and digital sampling approach to Kinoshita's wrist-worn pressure sensing device would have involved using known pressure-sensing and digital-signal-processing components according to their known functions.
One of ordinary skill in the art would have been motivated to make the modification because Mehrotra teaches that "[t]he two-dimensional array of pressure sensors increases the likelihood of obtaining accurate pressure sensor data from an applanated artery" and that the approach is "particularly advantageous in an ambulatory setting, where it may be difficult to locate an individual's artery, and the signals generated may be noisy" (Mehrotra, ¶[0011]). Thus, the modification would have predictably improved Kinoshita's wrist-worn pressure-based blood pressure measurement by increasing the likelihood of obtaining accurate pressure data from the artery despite placement variability and noise. The modification would have been no more than the use of a known pressure sensor array and known digital sampling technique to improve a similar wrist-worn pressure-based arterial blood pressure measurement device in the same way.
Regarding claim 44, the modified Kinoshita teaches that the data processing module is configured to transmit the dynamic pressure map to a biometric display unit, wherein the biometric display unit is physically coupled to the sleeve (Kinoshita, ¶[0072]: “In this case, the pressure signals stored in the memory 15 of the vital information measuring device are transmitted to the electronic equipment, and vital information is calculated and stored in the electronic equipment”, showing that pressure signal data from which a dynamic pressure map is generated is transmitted for processing and display; ¶[0076]: “The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13”, showing that the calculated blood pressure information is displayed continuously by the device; ¶[0060]: “The display section 13 is used for displaying various information including vital information, and includes, for example, a liquid crystal display”, confirming that the display unit receives and shows data derived from the pressure signal and is integrated with the wearable device structure; ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown" where the band is equivalent to the sleeve and the display is coupled to the measuring device (¶[0056], Fig. 5])).
Regarding claim 46, the modified Kinoshita teaches that the sleeve engages the portion of the limb of the wearer at an effective diameter (Kinoshita, ¶[0033]: "The vital information measuring device of the present embodiment is used while worn, with a band not shown", establishing the wearable nature of the device with a sleeve-like band engaging the limb; ¶[0059]: "The air bag drive section 11 includes a pump or the like, and controls the amount of air injected into the air bag 2 (the internal pressure of the air bag 2) in accordance with an instruction issued by the control unit 12", showing that a fluid actuation mechanism (air pump) changes the support's configuration for pressure application; ¶[0079]: "a state where the rotation drive section 10... rotates the sensor section 6 so that, with the pulse wave detection unit 100 worn on the wrist, the pressing surface 6b can be placed in uniform contact with the skin", confirming the support structure adapts for a proper fit around the limb, including variable pressing force states consistent with effective diameter control), the sleeve configurable in either: a non-occlusion configuration (Kinoshita, ¶[0206]: "The state where the radial artery T is appropriately pressed refers to a state where the radial artery T is not occluded... namely, what is called a tonometry state", showing that the device is operable in a non-occlusion configuration during normal pressure sensing; Fig. 8: depicts a zero pressure state at t0); or an occlusion configuration for occluding the blood vessel (Kinoshita, ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", showing that the device enters an occlusion configuration when needed; ¶[0218]: "The state where the pressing force is held at the first pressing value in step S4 is a state where the radial artery T is occluded by the selected element row", confirming the device can actively configure into an occlusion state).
Regarding claim 47, the modified Kinoshita teaches that the sleeve further comprises a partial occlusion configuration for partially occluding the blood vessel (Kinoshita, ¶[0206]: "The state where the radial artery T is appropriately pressed refers to a state where the radial artery T is not occluded... namely, what is called a tonometry state", showing a non-occlusion configuration; ¶[0210]: "the second pressing value is preferably set to an arbitrary numerical value corresponding to a range of the pressing force with which the AC level of the target element determined at each time in the selected element row is as high as 0.9 times or more of the maximum value... ", showing the device is operable in a state of partial occlusion, where the blood vessel is neither fully open nor fully closed; ¶[0211]: "The state where the pressing force is held at HDP ACmor is regarded to be the closest to the tonometry state", confirming that this intermediate pressing force correlates to a partial occlusion configuration).
Regarding claim 48, the modified Kinoshita expressly or inherently teaches that the effective diameter of the sleeve is reduced to occlude the blood vessel (Kinoshita, ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", showing that the device actively changes its pressing configuration to achieve occlusion; ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", confirming that the pressing surface of the device increases applied pressure until vessel occlusion is achieved through compression, effectively reducing the diameter of the encircling sleeve-like structure. The air bag expands within the band, pressing inward against the skin and thereby reducing the effective diameter of the wearable around the limb).
Regarding claim 49, the modified Kinoshita teaches that a mechanism to reduce the effective diameter of the sleeve comprises an actuator mechanism, a fluid actuation mechanism, or a combination thereof (Kinoshita, ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", showing that the system uses an air bag to apply force against the body for occlusion; ¶[0083]: "the control unit 12 controls the air bag drive section 11 to start injecting air into the air bag 2, so as to increase the pressing force applied by the sensor section 6 to the body surface", showing that the pressing mechanism is a fluid actuation mechanism; ¶[0079]: "the rotation drive section 10... rotates the sensor section 6 so that... the pressing surface 6b can be placed in uniform contact with the skin", showing an actuator mechanism used in conjunction with the fluid-driven bag to conform and press the device structure against the limb, thereby reducing the effective diameter of the wearable system).
Regarding claim 50, the modified Kinoshita teaches that the device is operable in a calibration mode, wherein operation in the calibration mode configures the sleeve in the occlusion configuration for calibrating baseline parameters the blood pressure of the wearer (Kinoshita, Fig. 6: shows the calibration sequence including occlusion and data generation for correction, verifying operation in calibration mode for baseline blood pressure determination; ¶[0114]: "the control unit 12 sets, as a first pressing value, a pressing force (HDPmor) of the air bag 2 applied at the time when the AC level... has reached the occlusion completion determination threshold value", showing the calibration mode actively presses to achieve full occlusion of the radial artery; ¶[0188]: "the control unit 12 increases the pressing force from the current value to a preliminarily determined value sufficient for occluding the radial artery T", confirming this pressing force corresponds to an occlusion state used in calibration; ¶[0195]: "the control unit 12 calculates the SBP and the DBP based on the thus generated pulse wave envelope data, and generates the correction data for correcting the SBP and the DBP based on the result of the comparison", showing that the system calibrates baseline blood pressure parameters during this occlusion configuration).
Regarding claim 51, the modified Kinoshita teaches that the device is operable in a continuous monitoring mode (Kinoshita, ¶[0076]: "The vital information measuring device of the present embodiment has a continuous blood pressure measurement mode in which the SBP and the DBP are calculated every heart rate to be displayed in the display section 13", showing that the system performs ongoing measurements in a continuous mode), wherein operation in the calibration mode configures the sleeve in the partial occlusion configuration for monitoring the blood pressure of the wearer (Kinoshita, Fig. 6; ¶[0210]: "the second pressing value is preferably set to an arbitrary numerical value corresponding to a range of the pressing force with which the AC level of the target element determined at each time in the selected element row is as high as 0.9 times or more of the maximum value", demonstrating that in the calibration process, the system identifies a pressing force below full occlusion, which is then used in continuous monitoring, consistent with a partial occlusion configuration; ¶[0211]: "The state where the pressing force is held at HDP ACmor is regarded to be the closest to the tonometry state", confirming that this partial occlusion force is used during ongoing pressure monitoring operations).
Regarding claim 52, the modified Kinoshita teaches that the device comprises a sensor array comprised of a plurality of sensing elements (Kinoshita, ¶[0039]: "the sensor section 6 includes an element row 60 including a plurality of pressure detecting elements 6a arranged in a direction B... and an element row 70 including a plurality of pressure detecting elements 7a arranged in the direction B", showing that the sensor array is composed of multiple pressure detecting elements; ¶[0040]: "Every pressure detecting element 6a forms a pair with a pressure detecting element 7a disposed in the same position in the direction B, and a plurality of such pairs are arranged in the direction B in the sensor section 6", confirming the sensor section comprises a grid-like array of pressure sensing elements that collectively function as a sensor array).
Regarding claim 55, the modified Kinoshita teaches that the blood pressure comprises a systolic blood pressure, a diastolic blood pressure, a mean blood pressure, a heart rate, a blood vessel viscoelasticity, an arterial stiffness, or a combination thereof (Kinoshita, ¶[0071]: "The control unit 12 calculates, as the vital information, for example, blood pressure information such as an SBP (systolic blood pressure) and a DBP (diastolic blood pressure), pulse information such as a pulse count, or heart rate information such as a heart rate", showing the derivation of systolic and diastolic pressures and heart rate from the pressure signal).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita et al. (US 20190046045 A1), hereto referred as Kinoshita, in view of Mehrotra et al. (US 2017/0367596 A1), hereto referred as Mehrotra, and further in view of Handler et al. (US 20190183362 A1), hereto referred as Handler, and further in view of Elgendi et al. (Elgendi, Mohamed et al. “The Use of Photoplethysmography for Assessing Hypertension.” NPJ digital medicine 2.1 (2019): 1--60. Web.), hereto referred as Elgendi.
Kinoshita teaches claim 18 and 21 and as described above.
Regarding claim 23, the modified Kinoshita does not teach that the method further comprises isolating one or more changes in pressure of the skin surface at the location of the blood vessel, wherein isolating the one or more changes in pressure of the skin surface at the location of the blood vessel comprises carrying out a time, frequency, and space domain clustering analysis of a comparison of the changes in pressure at the location of the blood vessel relative to one or more changes in pressure on the skin surface of the wearer at a location away from the blood vessel. Rather, the modified Kinoshita teaches identifying a target sensor element positioned above a blood vessel and analyzing both temporal and spatial aspects of pressure signals to locate that vessel (Kinoshita, ¶[0087], ¶[0130], ¶[0141]). However, it does not teach performing a clustering analysis in time, frequency, and space domains comparing signals from the vessel site to signals away from it. Handler fills the gap with respect to clustering analysis in the time and frequency domains using circulatory waveforms. Handler teaches that pressure signals can be segmented in the time domain using slope detection (Handler, ¶[0017]) and transformed into the frequency domain using fast Fourier transform (FFT) techniques (Handler, ¶[0065]). Handler further shows that different frequency-domain distributions can be compared to identify meaningful peaks related to physiological events (Handler, Fig. 7). These teachings demonstrate that Handler provides a basis for clustering analysis of pressure signals in the time and frequency domains. Elgendi fills the gap with respect to spatial domain analysis of pulse waveforms using photoplethysmographic signals. Elgendi teaches the use of multiple signal acquisition sites, such as the finger, earlobe, and toe, to monitor physiological signals (Elgendi, p. 1, 'PHOTOPLETHYSMOGRAPHY', R-col.). It also describes comparing photoplethysmographic waveforms from two different arterial sites to determine physiological parameters (Elgendi, p. 1, 'ELECTROCARDIOGRAPHY AND PHOTOPLETHYSMOGRAPHY' R-col.), thus supporting comparative spatial analysis of signals for identifying vascular features. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Kinoshita in view of Handler and Elgendi to perform a time, frequency, and space domain clustering analysis of pressure signals at and away from a blood vessel location. The combination would have been possible because each reference addresses compatible aspects of physiological waveform signal acquisition and analysis. Handler’s time and frequency domain clustering techniques could be directly applied to the pressure waveforms captured by Kinoshita’s sensor array, and Elgendi’s spatial analysis across multiple body sites could be incorporated to compare signals from vessel and non-vessel locations. Together, the domain-specific analyses taught by Handler and Elgendi would have guided a skilled artisan to group and distinguish waveform features across time, frequency, and space domains for isolating physiologic signal sources. The benefit of the combination would be improved differentiation and isolation of physiological pressure signals, enhancing the reliability of identifying blood vessel-specific signals and increasing the accuracy of derived physiological parameters.
Claims 39 and 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita et al. (US 20190046045 A1), hereto referred as Kinoshita, in view of Mehrotra et al. (US 2017/0367596 A1), hereto referred as Mehrotra, and further in view of Tal et al. (US 20180184923 A1), hereto referred as Tal.
Kinoshita teaches claim 28, 43, and 52 as described above.
Regarding claim 39, the modified Kinoshita teaches that the sensor array is comprised of a plurality of sensing elements, but does not teach that the sensing elements comprise polymeric thin-film transducers. Rather, the modified Kinoshita teaches a wearable physiological measurement device comprising a plurality of pressure sensing elements (¶[0040]), but does not disclose that those sensing elements are polymeric thin-film transducers. Tal also uses pressure sensors to measure blood pressure and teaches an array of pressure sensors made using polymeric foil materials such as Velostat or Linqstat, which change resistance under pressure and serve as individual sensor elements (¶[0081]–[0082]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Kinoshita in view of Tal to form the plurality of sensing elements using polymeric thin-film transducers. The combination would have been possible because both references disclose flexible pressure sensing arrays designed for wearable use. It would have been obvious to substitute the generic sensors in Kinoshita with the polymeric film-based sensors of Tal to improve flexibility, skin conformity, and manufacturing cost. The benefit of the combination would be a more comfortable, flexible, and cost-effective sensor array suitable for prolonged wearable use.
Regarding claim 53, the modified Kinoshita does not teach that the plurality of sensing elements comprises pressure detecting elements comprise thin-film transducers. Rather, the modified Kinoshita teaches a plurality of pressure detecting elements arranged in rows on a flat surface for physiological monitoring (¶[0040], ¶[0041]), but does not specify that these elements are thin-film transducers. Tal also uses pressure sensors to measure blood pressure and teaches a pressure sensor array made from polymeric piezoresistive thin-film materials such as Velostat and Linqstat, which serve as low-cost, flexible pressure transducers (¶[0081]–[0083]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Kinoshita in view of Tal to implement the plurality of sensing elements using thin-film piezoresistive transducers. The combination would have been possible because both references describe pressure sensor arrays for wearable physiological monitoring. It would have been obvious to substitute the generic sensing elements in Kinoshita with the thin-film polymeric sensors of Tal to improve comfort, flexibility, and manufacturability. The benefit of the combination would be a more flexible, biocompatible, and cost-effective sensor array suitable for continuous physiological monitoring in wearable applications.
Regarding claim 54, the modified Kinoshita does not teach that the thin-film transducers are polymeric thin-film transducers. Rather, the modified Kinoshita teaches the use of pressure detecting elements such as piezoresistive and capacitive types (¶[0040]) but does not disclose that they are formed from polymeric materials. Tal teaches that pressure sensor elements are implemented using piezoresistive electrically conductive film sheets, specifically Velostat and Linqstat, which are made from a polymeric foil (¶[0081]-[0083]). These polymeric materials serve as thin-film pressure transducers in Tal’s wearable pressure sensor array. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Kinoshita in view of Tal to form the thin-film transducers using polymeric materials. The combination would have been possible because both references address wearable pressure sensors. It would have been obvious to use polymeric thin-film materials like those in Tal to enhance flexibility, biocompatibility, and manufacturability of the sensing array in Kinoshita. The benefit of the combination would be a more compliant and skin-conforming sensor system that improves comfort and performance in wearable medical monitoring devices.
Response to Arguments
Objections
Applicant's arguments filed 11/18/2025, page 7, regarding the previous Objections of claims 18, 23, 27, and 50 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §102 and 103
Applicant's arguments filed 11/18/2025, page 7, regarding the previous 102 Rejections of claims 18-21, 24, 27-29, 31, 33, 35, 35. 37-38, 42-44, 46-52 and 55 and 103 Rejections of claims 23, 39, and 53-54 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Applicant's Argument: Applicant argues that claims 18, 23, 27, 28, and 43 have been amended to more particularly describe the dynamic pressure map, including that the dynamic pressure map is formed by an array of pixels, each pixel represents a position on an array of positions on the regions of skin on a wearer, and each pixel has an intensity value corresponding to pressure measured at that position on the regions of skin on a wearer. Applicant argues that Kinoshita does not teach generation of the dynamic pressure map of the present invention and does not describe the dynamic pressure map of the claimed invention as amended. Applicant therefore submits that the anticipation rejections should be withdrawn.
Examiner's Response: Applicant's argument has been considered but is moot in view of the new grounds of rejection. The prior anticipation rejection based on Kinoshita alone has not been maintained in the same form. The claims are now rejected under 35 U.S.C. 103 based on Kinoshita in view of Mehrotra.
The new rejection does not rely on Kinoshita alone as expressly teaching the amended dynamic pressure map. Rather, Kinoshita is relied upon for the wearable pressure-sensing system, pressure detecting elements positioned at the skin surface, spatially resolved pressure information, time-varying pressure signals, and calculation of vital information from detected pressure signals. The rejection expressly acknowledges that Kinoshita does not expressly teach acquiring the pressure information as a time series of pressure maps in which each pressure map is a two-dimensional array of pixels having intensity values corresponding to instantaneous pressure values at respective skin locations.
Mehrotra is now relied upon for the additional teaching of a wearable arterial tonometry system using a two-dimensional pressure sensor array, in which pressure sensor signals from the array are sampled and converted into a stream or series of digital amplitude values over time. Under the broadest reasonable interpretation of the amended claim language, and consistent with the supporting disclosure in the specification, a pressure map does not require a separately rendered image, visual display, or particular image file format. The claim defines the pressure map as a two-dimensional array of pixels, each pixel corresponding to a skin location and having an intensity value representing pressure from that location. Thus, when Mehrotra's two-dimensional pressure sensor array is sampled at a given time and the resulting digital amplitude values are associated with the known two-dimensional locations of the corresponding pressure sensors, that set of location-indexed pressure values forms the claimed pressure map. The successive sampled sets of digital amplitude values form the claimed dynamic pressure map.
Accordingly, Applicant's argument directed to Kinoshita alone does not overcome the new rejection based on the combination of Kinoshita and Mehrotra.
Applicant's Argument: Applicant argues that Handler and Elgendi provide examples of differential analysis methods that can be utilized on frequency domain distributions or spatial domain distributions, but neither provides for the use of dynamic pressure maps as described by the claimed invention.
Examiner's Response: Applicant's argument has been considered but is moot in view of the new grounds of rejection. The rejection has been modified to rely on Mehrotra for the amended dynamic pressure map features. Handler and Elgendi are not relied upon in the new rejection as the teaching of the amended dynamic pressure map. To the extent Handler and Elgendi are applied to dependent limitations in a separate rejection, Applicant's argument does not address the teachings for which those references are relied upon and instead attacks the references for allegedly failing to teach the dynamic pressure map features now addressed by the Kinoshita and Mehrotra combination.
Applicant's Argument: Applicant argues that Tal teaches an array of pressure sensors that give rise to modification of resistance under changes of pressure, providing a form of pressure measurement sensor, but neither Kinoshita nor Tal provides for the use of dynamic pressure maps as described by the claimed invention.
Examiner's Response: Applicant's argument has been considered but is moot in view of the new grounds of rejection. The rejection has been modified to rely on Mehrotra, rather than Tal, for the amended dynamic pressure map features. The new rejection expressly identifies the teachings of Kinoshita and the teachings missing from Kinoshita, and then relies on Mehrotra for the two-dimensional pressure sensor array, successive sampling, digital amplitude values, and location-indexed pressure values that form the claimed dynamic pressure map under the amended claim definition.
Accordingly, Applicant's argument directed to the prior Kinoshita and Tal combination does not overcome the new rejection based on Kinoshita in view of Mehrotra.
Applicant's Argument: Applicant requests withdrawal of the prior rejections based on the claim amendments.
Examiner's Response: Applicant's request has been considered. The prior rejections have been reconsidered in view of the amendments and remarks. However, the amendments do not place the claims in condition for allowance. The claims remain unpatentable for the reasons set forth in the new rejections. In particular, the new rejections expressly address the amended dynamic pressure map limitations using the combination of Kinoshita and Mehrotra, and the claims are also subject to the separate 35 U.S.C. 112(b) rejections set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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