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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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US application 18/620,021
US application 18/615,530
Claim 1
Claim 1
A physiological information measurement device, comprising: a pressure controller configured to control an applied pressure of a cuff to a predetermined site of a subject
A physiological information measurement device comprising: a pressure controller configured to execute a measurement of increasing or decreasing an applied pressure of a cuff with respect to a predetermined site of a subject from an initial value;
a pulse detector configured to detect pulses from a pressure received by the cuff from the predetermined site
a pulse detector configured to detect a pulse from a pressure received by the cuff from the predetermined site
a physiological information detector configured to detect physiological information on the subject
a pulse determination unit configured to determine whether the pulse detected by the pulse detector is a correctly detected pulse
a noise classification unit configured to classify whether detection data detected by the pulse detector is noise based on the physiological information
a blood pressure calculation possibility determination unit configured to determine whether calculation of a blood pressure of the subject is possible based on the pulse detected by the pulse detector
and a blood pressure calculator configured to calculate a blood pressure of the subject based on a plurality of the pulses that are classified as not noise by the noise classification unit.
and a blood pressure calculator configured to calculate the blood pressure of the subject based on a plurality of the pulses determined to be correctly detected by the pulse determination unit, wherein the pressure controller executes at least the measurement of a second time when the blood pressure calculation possibility determination unit determines that the calculation of the blood pressure is not possible in the measurement of a first time and a re-measurement is necessary, and the blood pressure calculator calculates the blood pressure of the subject based on a plurality of the pulses determined to be correctly detected by the pulse determination unit in the measurement of a first time or a second and subsequent times.
Claim 1 is provisionally rejected on the ground of provisional nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. patent application Kuroda et al. (18/615,530), hereinafter Kuroda, in view of Harada et al. (US 5759157 A), hereinafter Harada. The claims of the instant application and the claims of the reference application are compared in the table above.
Claim 1 of Kuroda recites the limitations of claim 1 of the instant application as follows: “[Executing] a measurement of increasing or decreasing an applied pressure of a cuff with respect to a predetermined site of a subject from an initial value” falls within the scope of the first element “control an applied pressure of a cuff…”, the pulse detector element of both claims is exactly the same, and “the pulse detected by the pulse detector is a correctly detected pulse” is within the scope of “physiological information on the subject”.
Kuroda does not recite the limitation “a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information; and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step”.
However, Harada teaches a blood pressure measuring device which judges whether a first blood pressure measurement value is noise (Figure 3, Column 6 lines 63-67 and column 7 line 1) and calculates blood pressure of a subject based on pulses determined to not be noise (Figure 3, Column 6, lines 63 - 67 and column 7 line 1). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use a noise detection unit to determine if the first blood pressure measurement was possible and to calculate blood pressure based on pulses determined to not be noise. This would reduce the time needed for blood pressure measurement and reduce patient discomfort (Harada, Column 7 lines 5- 9).
US application 18/620,021
US application 18/615,530
Claim 7
Claim 8
A physiological information measurement method, comprising: a pressure control step of controlling an applied pressure of a cuff to a predetermined site of a subject; a pulse detection step of detecting pulses from a pressure received by the cuff from the predetermined site; a physiological information detection step of detecting physiological information on the subject; a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information; and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step.
A physiological information measurement method comprising: executing a measurement of increasing or decreasing an applied pressure of a cuff with respect to a predetermined site of a subject from an initial value; detecting a pulse from a pressure received by the cuff from the predetermined site; first determining whether the pulse detected in the detecting is a correctly detected pulse; second determining whether calculation of a blood pressure of the subject is possible based on the pulse detected in the detecting; and calculating the blood pressure of the subject based on a plurality of the pulses determined to be correctly detected in the first determining, wherein in the executing, at least the measurement of a second time is executed when it is determined in the second determining that the calculation of the blood pressure is not possible in the measurement of a first time and a re-measurement is necessary, and in the calculating, the blood pressure of the subject is calculated based on a plurality of the pulses determined to be correctly detected in the first determining in the measurement of a first time or a second and subsequent times.
Claim 7 is provisionally rejected on the ground of provisional nonstatutory obviousness-type double patenting as being unpatentable over claim 8 of U.S. patent application Kuroda (18/615,530), in view of Harada (US 5759157 A). The claims of the current application and the claims of the reference application are compared in the table above.
Claim 8 of Kuroda recites the limitations of claim 7 of the instant application as follows: “Increasing or decreasing an applied pressure of a cuff” is within the scope of “a pressure control step of controlling an applied pressure”, “detecting a pulse” is effectively the same as “a pulse detection step”, and “detecting a pulse from a pressure received by the cuff from the predetermined site” is within the scope of “a physiological information detection step of detecting physiological information on the subject”.
Kuroda does not recite the limitation of “a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information; and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step”.
However, Harada teaches a method of measuring blood pressure which judges whether a first blood pressure measurement value is noise based on pulses (Figure 3, Column 6 lines 63-67 and column 7 line 1) and calculates blood pressure of a subject based on pulses determined to not be noise (Figure 3, Column 6, lines 63 - 67 and column 7 line 1). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use a noise detection unit to determine if the first blood pressure measurement was possible and to calculate blood pressure based on pulses determined to not be noise . This would reduce the time needed for blood pressure measurement and reduce patient discomfort (Harada, Column 7 lines 5-9).
US application 18/620,021
US application 18/615,530
Claim 8
Claim 9
A non-transitory computer-readable storage medium storing a program for causing a computer to execute:
A non-transitory computer readable storage medium storing a program for causing a computer to execute a physiological information measurement method according to claim 8.
a pressure control step of controlling an applied pressure of a cuff to a predetermined site of a subject; a pulse detection step of detecting pulses from a pressure received by the cuff from the predetermined site; a physiological information detection step of detecting physiological information on the subject; a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information, and classifying the detection data if the detection data is noise; and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step.
Claim 8:
executing a measurement of increasing or decreasing an applied pressure of a cuff with respect to a predetermined site of a subject from an initial value; detecting a pulse from a pressure received by the cuff from the predetermined site; first determining whether the pulse detected in the detecting is a correctly detected pulse; second determining whether calculation of a blood pressure of the subject is possible based on the pulse detected in the detecting; and calculating the blood pressure of the subject based on a plurality of the pulses determined to be correctly detected in the first determining, wherein in the executing, at least the measurement of a second time is executed when it is determined in the second determining that the calculation of the blood pressure is not possible in the measurement of a first time and a re-measurement is necessary, and in the calculating, the blood pressure of the subject is calculated based on a plurality of the pulses determined to be correctly detected in the first determining in the measurement of a first time or a second and subsequent times.
Claim 8 is provisionally rejected on the ground of provisional nonstatutory obviousness-type double patenting as being unpatentable over claim 9 of U.S. patent application Kuroda (18/615,530), in view of Harada (US 5759157 A). The claims of the current application and the claims of the reference application are compared in the table above.
Claim 9 of Kuroda recites the limitations of claim 8 of the instant application as follows: “A non-transitory computer readable storage medium storing a program for causing a computer to execute a physiological information measurement method “ is the same as “A non-transitory computer-readable storage medium storing a program for causing a computer to execute a physiological information measurement method”. Regarding the limitations of claim 8 of Kuroda, which claim 9 inherits, “Increasing or decreasing an applied pressure of a cuff” is within the scope of “a pressure control step of controlling an applied pressure”, “detecting a pulse” is effectively the same as “a pulse detection step”, and “detecting a pulse from a pressure received by the cuff from the predetermined site” is within the scope of “a physiological information detection step of detecting physiological information on the subject”.
Kuroda does not recite the limitation of “a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information, and classifying the detection data if the detection data is noise; and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step.”
However, Harada teaches a method of measuring blood pressure which judges whether a first blood pressure measurement value is noise based on pulses (Figure 3, Column 6 lines 63-67 and column 7 line 1) and calculates blood pressure of a subject based on pulses determined to not be noise (Figure 3, Column 6, lines 63 - 67 and column 7 line 1). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use a noise detection unit to determine if the first blood pressure measurement was possible and to calculate blood pressure based on pulses determined to not be noise . This would reduce the time needed for blood pressure measurement and reduce patient discomfort (Harada, Column 7 lines 5-9).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harada et al. (US 5759157 A), hereinafter Harada.
Regarding claim 1, Harada teaches a physiological information measurement device, comprising: a pressure controller configured to control an applied pressure of a cuff to a predetermined site of a subject (Figure 2, column 5 lines 2-10); a pulse detector configured to detect pulses from a pressure received by the cuff from the predetermined site (Column 5 lines 49-50); a physiological information detector configured to detect physiological information on the subject (Figure 2, column 4 lines 64-67 and column 5 lines 1-4); a noise classification unit configured to classify whether detection data detected by the pulse detector is noise based on the physiological information (Column 6 lines 1-13); and a blood pressure calculator configured to calculate a blood pressure of the subject based on a plurality of the pulses that are classified as not noise by the noise classification unit (Figure 3, Column 6 lines 1- 37).
Regarding claim 2, Harada teaches a physiological information measurement device, wherein the physiological information includes at least one of a heart rate, a pulse rate, or an electrocardiogram (Column 4 lines 64-67).
Regarding claim 7, Harada teaches a physiological information measurement method, comprising: a pressure control step of controlling an applied pressure of a cuff to a predetermined site of a subject (Figure 2, column 5 line 2-10); a pulse detection step of detecting pulses from a pressure received by the cuff from the predetermined site (Column 5 lines 49-50); a physiological information detection step of detecting physiological information on the subject (Figure 2, column 4 lines 64-67 and column 5 lines 1-4); a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information (Column 6 lines 1-13); and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step (Figure 3, Column 6 lines 1- 37).
Regarding claim 8, Harada teaches a non-transitory computer-readable storage medium storing a program for causing a computer to execute: a pressure control step of controlling an applied pressure of a cuff to a predetermined site of a subject (Figure 2, column 5 lines 2-10); a pulse detection step of detecting pulses from a pressure received by the cuff from the predetermined site (Column 5 lines 49-50); a physiological information detection step of detecting physiological information on the subject (Figure 2, column 4 lines 64-67 and column 5 lines 1-4); a noise classification step of classifying whether detection data detected in the pulse detection step is noise based on the physiological information, and classifying the detection data if the detection data is noise (Column 6 lines 1-13); and a blood pressure calculation step of calculating a blood pressure of the subject based on a plurality of the pulses that are classified as not noise in the noise classification step (Column 4 lines 50-58, Column 4 lines 64-67 and column 5 lines 1-29).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Harada (US 5759157 A) as applied to claims 1 and 2 in view of Sato (US 20180092552 A1).
Harada discloses all of the elements of the current invention as discussed above except the noise classification unit which classifies whether the detection data detected by the pulse detector is noise based on an average beat interval calculated from the heart rate, an average pulse interval calculated from the pulse rate, or an RR interval and a rising time point of a waveform in the electrocardiogram. Sato teaches a blood pressure measurement system which uses an average pulse interval to identify noise ([0011]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to implement a noise classification unit similar to that of Sato in combination with the invention of Harada in order to reduce noise from subject movement.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Harada (US 5759157 A) in view of Sato (US 20180092552 A1), further in view of Vu et al. (US 20220280056 A1), hereinafter Vu.
Regarding claim 4, Harada, as modified with Sato, discloses all of the elements of the current invention as discussed above except the physiological information measurement device, wherein the noise classification unit calculates an interval of the detection data detected by the pulse detector, and classifies the detection data as noise if the detection data is detected at an interval deviated from the average beat interval or the average pulse interval by a predetermined ratio or more. Vu teaches a blood pressure measurement system which classifies noise based on the standard deviation of pulse intervals within a certain window and whether that standard deviation falls below a certain threshold ([0048], [0075]). Standard deviation is a measure of variation of values about an average, and a low standard deviation indicates that data points are closer to the mean. Therefore, the blood pressure measurement system of Vu detects noise if the detection data is detected at a certain interval deviated from the average pulse interval by a predetermined ratio or more. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to classify noise using a system similar to that of Vu in an apparatus like that of Harada, as modified with Sato, in order to detect and reduce noise from a subject.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harada (US 5759157 A) in view of Sato (US 20180092552 A1), further in view of Ogura et al. (US 5752920 A), hereinafter Ogura.
Harada, as modified with Sato, discloses all of the elements of the current invention as discussed above except the physiological information measurement device, wherein the noise classification unit calculates an interval between peaks and the rising time point of the waveform of the detection data detected by the pulse detector, and classifies the detected detection data as noise if the interval between peaks of the waveform of the detection data deviates from the RR interval by a predetermined ratio or more, or if the rising time point of the waveform of the detection data deviates from the rising time point of the waveform in the electrocardiogram by a predetermined ratio or more. Ogura teaches a blood pressure measuring apparatus which classifies detected data as noise if the interval between peaks of the waveform deviates from the RR interval by a predetermined ratio of more (Column 9 lines 45-59, Column 11 lines 49-59). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to classify noise using an apparatus similar to that of Ogura in a system like that of Harada, as modified with Sato, to increase the reliability of the blood pressure measurement.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Harada as applied to claim 1 in view of Aung et al. (US 5243990 A), hereinafter Aung.
Harada discloses all of the elements of the current invention as discussed above except if the blood pressure calculation possibility determination unit determines that the blood pressure cannot be calculated in the measurement step of a first time, the pressure controller executes the measurement step of at least a second time, and if the blood pressure calculation possibility determination unit determines that the blood pressure cannot be calculated in any measurement step, the pressure controller sets a minimum value within a range in which the pulse necessary for calculating the blood pressure can be detected as the initial value of the applied pressure in a next measurement step based on a determination result by the blood pressure calculation possibility determination unit. Aung teaches a blood pressure monitoring system which determines whether blood pressure can be calculated within a certain time and re-measures, where the applied pressure is increased by a minimum amount in the remeasurement (Column 2, lines 14-22, column 5 lines 15-68 and column 6 lines 1-5). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to configure a pressure controller, such as the one in Harada’s system, to set a minimum value within a range in which the pulse necessary for calculating the blood pressure is detectable as the initial value of the applied pressure in the measurement of the next time, similar to the system in Aung, to reduce the burden to the subject caused by the pressure of the cuff and to reduce the time needed to measure patient blood pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Usuda et al. (US 20090112104 A1) teaches a blood pressure measuring apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571)305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, can be reached at telephone number (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/ Supervisory Patent Examiner
Art Unit 3791
/EMILY R UCHITEL/ Examiner, Art Unit 3791
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