DETAILED ACTION
Claims 1-10 are hereby the present claims under consideration
Examiner’s Note: all references to Applicant’s specification have been made using the paragraph number assigned in the US publication of the present application US 20250120601 A1.
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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A blood pressure measurement unit in claims 1 and 6
A determination unit in claims 1 and 6
A mode setting unit of claims 1 and 6
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A blood pressure measurement unit in claims 1 and 6 is interpreted as the particular algorithm for carrying out the recited function. In particular, the blood pressure measurement unit is interpreted as the algorithm for automatically performing blood pressure measurement in one of a plurality of blood pressure measurement modes according to a predetermined schedule; determining whether a predetermined period has elapsed from previous blood pressure measurement when one of the first to third measurement modes have been set as active measurement mode; performs blood pressure measurement in a measurement mode set as the active measurement mode when the predetermined time period has not elapsed; sets the measurement mode to the normal measurement mode when the predetermined time period has elapsed; measures the blood pressure of the user in the first pressurization process (claim 1) or the depressurization process (claim 6); and measures the blood pressure of the user in the second measurement mode (claim 1) or the third measurement mode (claim 6). Paragraphs 0082-0086 describe the function of the blood pressure measurement unit as receiving signals from the blood pressure cuff and calculating a blood pressure and pulse rate therefrom but do not describe the particular method used to perform such calculations. In particular, no specific method of calculating pulse rate is provided. Paragraphs 0055 and 0069-0070 recite that the blood pressure determination uses the oscillometric method and thus the method to perform blood pressure calculations is interpreted as the oscillometric methos and its equivalents. The specification describes the process for controlling the blood pressure cuff to carry out the measurement in the different modes (Figs. 6-7 for normal pressurization/depressurization mode and mode 4 which activates based on body movement as in Fig. 17; Figs. 8-9 for the first mode in pressurization/depressurization; Fig. 13 for mode 2; Fig. 16 for mode 3). These flow charts show the operation of the pump and valves according to the measurement modes and are considered to fully describe the different measurement modes except for those that require pulse rate determination since the particular algorithm for determining pulse rate has not been provided. As such, the specification is not considered to describe the specific algorithm for carrying out all of the recited functions of the blood pressure calculation unit since the pulse rate determination method is not provided.
A determination unit in claims 1 and 6 is interpreted as the particular algorithm for carrying out the recited function. In particular, the determination unit is interpreted as the particular algorithm for determining whether any of a plurality of predetermined events has occurred in the user while the blood pressure measurement unit was measuring a blood pressure; determines whether an irregular pulse wave has occurred; and determines whether an arrhythmia has occurred. Paragraphs 0092-0098 describe that the determination unit detects the events of irregular pulse waves, arrythmias, and body motion. The determination unit detects an irregular pulse wave by determining if the pulse wave deviates by 25% or more from the average value. However the specification does not set forth the particular metrics that are evaluated for this deviation determination to identify the irregular pulse waves. The specification further recites that arrhythmia is a type of irregular pulse wave but fails to provide the particular method for determining arrythmia. Paragraph 0094 indicates that arrhythmia is determined based on a regularity of pulse waves but does not provide the specific method for making the arrhythmia detection. Paragraphs 0095-0097 recite that body motion is detected by a predetermined amplitude deviation in pulse wave magnitude between pulses or the cuff pressure changes by more than a threshold amount in a period of time. The body motion may be detected from an acceleration sensor by determining the average value of the acceleration sensor output for each period and determining a variation amount for each period with respect to an average and detects motion when the square root of the sums of squares of the variation exceed a threshold value. Thus, the specification is not considered to disclose the specific algorithm required to carry out all of the functions of the determination unit because the specification does not describe the particular metrics used to identify irregular pulse waves using the 25% deviation criteria, and the specification does not describe the particular algorithm for detecting arrhythmia.
A mode setting unit of claims 1 and 6 is interpreted as the particular algorithm for carrying out the recited function. In particular, the mode setting unit is interpreted as the particular algorithm for setting an active measurement mode based on a determination result, wherein the normal mode is set when no events have occurred and one of the first through third measurement modes when one of the events has occurred and setting the second (claim 1) or third (claim 6) modes when irregular pulse waves have occurred more than a predetermined number of times in the past reference number of measurements or when irregular pulse waves have occurred consecutively more than a predetermined number of times. Paragraphs 0109-0176 describe how each mode (M1-M3) may be selected when irregular pulse waves or arrhythmias are detected. These paragraphs indicate that any of the modes M1-M3 may be selected for the same occurrence of events. This is particularly highlighted by paragraph 0165 which indicates that any of the mode may be chosen for the same detected event. Paragraph 0103 indicates that one of the modes M1-M3 is selected in accordance with a particular pattern set in the blood pressure gauge but the patterns are not described. Thus, the specification is not considered to describe the particular algorithm for performing the recited function of setting one of the first through third measurement modes as the active pattern based on the determination result because the specification does not describe how the algorithm selects between the first through third measurement modes when the events are detected. In particular, the patterns used to select one of the modes over the other two have not been described.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Claim 1 line 11 it appears that “was measuring a blood pressure” should read “was performing the blood pressure measurement”
Claim 1 lines 16-17 and line 19 it appears that “the plurality of measurement modes” should read “the plurality of measurement modes having higher reliability” or the like to better distinguish between “the plurality of blood pressure measurement modes” and “the plurality of measurement modes” This objection is further applied to the similar recitations in claims 6, 9, and 10.
Claim 1 lines 21-22 it appears that “a predetermined period has elapsed from previous blood pressure measurement” should read “a predetermined period of time has elapsed from a previous blood pressure measurement’ It would seem that each following instance of “predetermined period” should read “the predetermined period of time”
Claim 1 lines 24-25 it appears that “performs blood pressure measurement in a measurement mode set as the active measurement mode” should read “performs the blood pressure measurement in the measurement mode of the plurality of measurement modes with higher reliability set as the active measurement mode” or “performs blood pressure measurement in the active measurement mode”
Claim 1 line 30 it appears that “a blood pressure of the user” should read “the blood pressure of the user”
Claim 1 lines 32-33 it appears that “a measurement site of the user” should read “the measurement site of the user”
Claim 1 line 37 it appears that “when no irregular pulse wave has occurred” should read “ when the irregular pulse wave has not occurred”
Claim 1 lines 38-39 it appears that “the number of times an irregular pulse wave has occurred” should read “a number of times the irregular pulse wave has occurred”
Claim 1 lines 39-40 it appears that “the most recent specified number of times of blood pressure measurement” should read “a specified number of most recent blood pressure measurements”
Claim 1 lines 41-42 it appears that “irregular pulse waves have consecutively occurred a predetermined number of times” should read “the irregular pulse waves consecutively occur a predetermined number of times in a current blood pressure measurement”
Claim 1 line 43 it appears that “a blood pressure of the user” should read “the blood pressure of the user”
Each of the above objections to claim 1 are similarly applied to claims 6, 9, and 10 which recite substantially similar limitations though line numbers and precise wording may differ.
Claims 2-5 each recite “an arrhythmia” or “arrhythmia” each of these limitations should read “the arrhythmia”
Claim 2 lines 2-3 it appears that “the first measurement modes is a first measurement mode in which blood pressure measurement is consecutively performed” should read “the first measurement mode of the plurality of measurement modes with higher reliability comprises consecutively performing blood pressure measurement”
Claim 2 line 3 it appears that “a plurality of times or more” should read “a plurality of times”
Claim 2 line 6 it appears that “performs blood pressure measurement” should read “performs the blood pressure measurement”
Claim 3 lines 2-3 it appears that “when no arrhythmia has occurred” should read “ when the arrhythmia has not occurred”
Claim 4 line 3 it appears that “no arrhythmia has occurred” should read “the arrhythmia has not occurred”
Claim 4 lines 4-5 it appears that “the number of times an arrhythmia has occurred” should read “a number of times the arrhythmia has occurred”
Claim 4 lines 6-7 it appears that “a reference number of times if an arrhythmia has occurred” should read “a reference number of times of the arrhythmia occurring”
Claims 6 lines 31-33 it appears that “reducing the cuff pressure after a second pressurization process of increasing a cuff pressure indicating a pressure inside the cuff worn around a measurement site of the user” should read “reducing a cuff pressure, indicating a pressure inside the cuff worn around the measurement site of the user, after a second pressurization process of increasing the cuff pressure” This objection is further applied to the similar limitations in claim 10.
Claims 7-8 it appears that each instance of “a body motion”, “body motion”, and “no body motion has” after line 3 of claim 7 should recite “the body motion”, “the body motion”, and “the body motion has not” respectively.
Claim 7 lines 5-6 it appears that “performs blood pressure measurement” should read “performs the blood pressure measurement”
Claims 9 and 10 lines 1-3 it appears that “measuring a blood pressure for a blood-pressure gauge for measuring a blood pressure by compressing a measurement site of a user with a cuff, the method for measuring a blood pressure comprising” should read “measuring a blood pressure using a blood-pressure gauge for measuring the blood pressure by compressing a measurement site of a user with a cuff, the method for measuring the blood pressure comprising”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
In claims 1 and 6, the claim limitations “A blood pressure measurement unit”, “a determination unit”, and “a mode setting unit” each invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function as described in the above presented claim interpretation section. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 1 recites “automatically perform blood pressure measurement in one of a plurality of blood pressure measurement modes according to a predetermined schedule” which appears to indicate that the mode for performing blood pressure determination is selected according to a predetermined schedule. This appears to conflict with the following claim limitation that indicate that the blood pressure measurement mode is determined based on the detection of events. For the purposes of this examination, the limitation will be interpreted as “automatically perform blood pressure measurement according to a predetermined schedule using a plurality of blood pressure measurement modes” This rejection and interpretation are further applied to the similar limitations in claims 6, 9, and 10.
Claim 1 recites “a determination unit configured to determine whether any of a plurality of predetermined events has occurred “, “the determination unit determines whether an irregular pulse wave has occurred in the user based on the pulse wave signal in the first pressurization process” and “the determination unit determines whether an arrhythmia has occurred in the user based on the pulse wave signal in the first pressurization process” but it is unclear if the “predetermined events”, “irregular pulse wave” and/or “arrhythmia” are the same as, related to, different from, or subsets of each other. For the purposes of this examination, the arrhythmia will be interpreted as being a subset of irregular pulse waves and the irregular pulse waves are interpreted as a subset of the predetermined events. This rejection and interpretation are further applied to the similar limitations in claims 6, 9, and 10.
Claim 1 recites “sets the second measurement mode as the active measurement mode when the number of times an irregular pulse wave has occurred in the most recent specified number of times of blood pressure measurement is equal to or greater than a reference number of times or when irregular pulse waves have consecutively occurred a predetermined number of times” but it is unclear if the limitation “an irregular pulse wave has occurred in the most recent specified number of times of blood pressure measurement is equal to or greater than a reference number of times” is meant to refer to the number of occurrences of the irregular pulse wave or the number of blood pressure measurements that included irregular pulse waves. It is further unclear if the limitation “when irregular pulse waves have consecutively occurred a predetermined number of times” is meant to refer to detecting consecutive pulse waves in a single blood pressure measurement (i.e. in a single blood pressure measurement session X consecutive waves are irregular) or if the limitation is meant to refer to the detection of irregular waves in consecutive blood pressure measurement sessions (i.e. Y consecutive blood pressure measurement sessions have included irregular pulse waves). For the purposes of this examination, the claim will be interpreted as requiring either a total number of irregular wave detections in the span of X blood pressure measurement’s or requiring consecutive detection of irregular waves in a single blood pressure measurement session. This rejection and interpretation are further applied to the similar limitations in claims 6, 9, and 10 including the setting of the second or third measurement mode. This rejection and interpretation are also similarly applied to the setting of the first measurement mode in claims 4-5 which recite that “the number of time an arrhythmia has occurred in a most recent specified number of times of blood pressure measurement” and “when arrhythmias have consecutively occurred a predetermined number of times”. It is unclear if these limitations are meant to refer to individual occurrences of arrhythmia or the labeling of blood pressure measurement cycles as containing arrhythmia.
Claim 1 recites “the blood pressure measurement unit measures a blood pressure of the user based on the pulse wave signal in the first pressurization process in the second measurement mode, and continues the first pressurization process until a first pulse rate of the user acquired based on the pulse wave signal in the first pressurization process reaches a threshold or higher” the spacing and wording of these limitations makes it unclear if the limitation “continues the first pressurization process until a first pulse rate of the user acquired based on the pulse wave signal in the first pressurization process reaches a threshold or higher” is performed as part of or because of the selection of the second measurement mode or if this operation is part of the regular operations of the blood pressure measurement unit. For the purposes of this examination, the operation of “continues the first pressurization process until a first pulse rate of the user acquired based on the pulse wave signal in the first pressurization process reaches a threshold or higher” is interpreted as being part of the second measurement mode and not part of the normal measurement mode. This rejection and interpretation are further applied to the similar limitations in claims 6, 9, and 10 including the setting of the second or third measurement mode.
Claims 2-5 are rejected by virtue of their dependance on claim 1.
Claims 7-8 are rejected by virtue of their dependance on claim 6.
Claim 2 recites “blood pressure measurement is consecutively performed a plurality of times or more” but it is unclear if the consecutive blood pressure measurement is meant to refer to the automatic blood pressure measurement on a predetermined schedule as recited in claim 1 or if the consecutive measurement is meant to replace a single measurement in the scheduled measurements. For the purposes of this examination the limitation is interpreted as replacing a single blood pressure measurement with a plurality of consecutive measurements.
Claim 2 recites “the determination unit determines whether an arrhythmia has occurred in the user based on a pulse wave signal obtained when the blood pressure measurement unit performs blood pressure measurement” but it is unclear if this arrhythmia determination is the same as, related to or different from the arrhythmia determination of claim 1. It is further unclear if “based on a pulse wave signal obtained when the blood pressure measurement unit performs blood pressure measurement” is the same as, related to, or different from the first pressurization signal used for arrhythmia detection and blood pressure measurement in claim 1.
Claim 4 recites “a most recent specified number of times of blood pressure measurement” but it is unclear if this limitation is the same as or different from “the most recent specified number of times of blood pressure measurement” of claim 1. For the purposes of this examination, the limitations are interpreted as different numbers of times.
Claim 4 recites “a reference number of times” but it is unclear if this reference number of times with respect to arrhythmia occurrence is the same as or different from the “reference number of times” of irregular pulse waves occurring of claim 1. For the purposes of this examination, the limitations are interpreted as referring to different numbers of times.
Claim 5 recites “a predetermined number of times” but it is unclear if this reference number of times with respect to arrhythmia occurrence is the same as or different from the “predetermined number of times” of irregular pulse waves occurring of claim 1. For the purposes of this examination, the limitations are interpreted as referring to different numbers of times.
Claim 8 recites the limitation "the current blood pressure measurement" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 1 and 6, the claim limitations “A blood pressure measurement unit”, “a determination unit”, and “a mode setting unit” each invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function as described in the above presented claim interpretation section. Therefore, the claim lacks sufficient written description and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Prior Art
Examiner’s Note: It is noted that the below prior art analysis is done based on the understanding of the claims in light of the above presented 35 USC 112 rejections. Amendments which change the interpretation of the claims may necessitate new grounds of rejection.
The closest prior art of record is considered to be:
Yamashita the machine English translation of International Patent Application Publication Number WO 2021085042 A1 hereinafter Yamashita which teaches a sphygmomanometer including a storage unit that stores a measured blood pressure value. In a nocturnal blood pressure measurement mode, blood pressure measurement is automatically started according to a schedule, and when a blood pressure measurement cuff is being pressurized or decompressed, a blood pressure is measured. Furthermore, it is determined whether the measured current blood pressure value differs from the past blood pressure value stored in the storage unit by exceeding an allowable range. When the current blood pressure value differs from the past blood pressure value by exceeding the allowable range, it is determined which of a plurality of predetermined types of phenomena has occurred in a subject. A remeasurement time after a current blood pressure value measurement time is variably set according to which of the plurality of types of phenomena has occurred (Abstract). Yamashita teaches a cuff based sphygmomanometer which initiates measurement according to a predetermined schedule (Page 3 paragraphs 3-5). Yamashita teaches the detection of a plurality of predetermined events including the detections of irregular pulse waves, arrhythmia, and body motions based on the pulse wave signal (Page 4 paragraph 4 – Page 5 paragraph 1). The device reschedules a measurement when one of the phenomena affect blood pressure measurement is detected (Page 9 paragraph 4). The blood pressure may also be calculated during depressurization of the cuff (Page 11 paragraph; Page 13 paragraph 3 ).
Usuda US Patent Application Publication Number US 20090112104 A1 hereinafter Usuda teaches a method of calculating a blood pressure, including: providing a non-invasive blood pressure measurement apparatus which includes a cuff being inflatable and deflatable and adapted to be fitted on a part of a living body and in which a plurality of calculation methods each of which has priority in accordance with a type of noise information are set; detecting, by the cuff, a signal waveform representing a change in an oscillation amplitude and a change in a cuff pressure; determining the type of the noise information contained in the detected signal waveform; deciding the blood pressure from at least one candidate value for the blood pressure, which is calculated by one of the calculation methods that has the priority with respect to the determined type of the noise information; and displaying the decided blood pressure (Abstract). Usuda teaches the detection of different types of noise, or events, in pulse wave signals and changing the measurement mode based on the type of noise detected (Paragraph 0007). Usuda teaches that when arrythmia is detected, the device may use a normal calculation method, a moving average calculation method, a calculation method that uses wavelet processing, and a calculation method that uses filter bank processing (Paragraph 0021). The system determines a type of noise in a pulse signal and assigns a priority order to the different measurement calculation methods (Paragraphs 0038-0039).
Muehlsteff US Patent Application Publication Number US 20180042493 A1 hereinafter Muehlsteff teaches a system and method wherein a control signal for a blood pressure measurement device, wherein the measurement device has parameters that may be adjusted to affect the precision of measuring and the method involves altering the parameters of the device based on a patient comfort (Abstract). Muehlsteff teaches a method of altering the operational parameters of a blood pressure measurement device to affect the precision of measurement. The operational parameters include a maximum pressure applied to a limb of a patient, an integral of the pressure over time, a duration of a measurement, a number of detected heartbeats or combinations of these or other parameters (Paragraphs 0021-0023). The operational settings of the blood pressure measurement may be adapted based on the results of a blood pressure measurement and patient comfort. The modifications to operational parameters can further include switching the measurement mode from an inflation mode to a deflation mode and changing the measurement modality based on detected events such as arrythmias (Paragraphs 0098-0102).
Takano US Patent Application Publication Number US 20210068843 A1 hereinafter Takano teaches a pressurizing tourniquet (Abstract). Takano teaches that blood pressure measurement may be performed with the device and that the user’s pulse rate may be measured. The measured pulse rate may be used to alter the rate or pressurization and depressurization to reduce the time required for measurement when the heart rate is high (Paragraphs 0224-0225). The control of the inflation and/or deflation rate based on pulse rate in order to guarantee a certain number of pulse waves is further taught by US Patent Application Publication Number US 20250221628 A1 Schmitt paragraph 0145.
LaBarbera US Patent Application Publication Number US 20210142896 A1 hereinafter LaBarbera teaches a patient data collection system (Abstract). LaBarbera teaches that a cuff may be configured to inflate to determine a patient’s pulse rate then perform blood pressure measurement once a desired pulse rate is achieved (Paragraph 0060)
Murray US Patent Application Publication Number US 20150250390 A1 hereinafter Murray teaches a blood pressure measurement device (Abstract). Murray teaches that blood pressure measurement may only be initiated once a heart rate threshold is satisfied (Paragraph 0021).
Thus in regards to claim 1, as best understood in light of the above presented 35 USC 112 rejections, none of the prior art of record teaches or reasonably suggests the device including “the blood pressure measurement unit determines whether a predetermined period has elapsed from previous blood pressure measurement when one of the first to third measurement modes has been set as the active measurement mode, performs blood pressure measurement in a measurement mode set as the active measurement mode among the first to third measurement modes when the predetermined period has not elapsed, and sets the normal measurement mode as the active measurement mode and performs blood pressure measurement in the normal measurement mode when the predetermined period has elapsed,” and the second measurement mode including “continues the first pressurization process until a first pulse rate of the user acquired based on the pulse wave signal in the first pressurization process reaches a threshold or higher” in combination with the other claimed elements.
In particular, the second measurement mode including “continues the first pressurization process until a first pulse rate of the user acquired based on the pulse wave signal in the first pressurization process reaches a threshold or higher” is considered a separate and distinct method from that of the prior art which teaches the adaptive control of inflation speed on the basis of pulse rate and the initiation of blood pressure measurement based on a threshold pulse rate. The claimed second measurement mode set forth requiring that the first pressurization process continues (i.e. the cuff is continually inflated) until a threshold pulse rate is reached. Such a continual inflation until a pulse rate is reached is distinct from the control of inflation rate based on heart rate because the control of the inflation rate does not have a set heart rate at which point the inflation ends and the claimed method is further distinct from a required threshold heart rate being satisfied before taking blood pressure measurement because, as described in LaBarbera, the inflation of the cuff is set to measure a heart rate and does not increase further until the heart rate criteria are satisfied (LaBarbera: paragraph 0060: the cuff is partially inflated to monitor pulse rate). Thus the claimed continual increase in cuff pressure until a threshold heart rate is achieved is considered to be separate and distinct from the measurement modes of the prior art.
Claims 6, 9, and 10 recite the same limitations not taught by the prior art as described with respect to claim 1 above. Claims 6 and 10 differ in that the measurement is performed during depressurization and using a “third” measurement mode but the measurement of blood pressure during depressurization is also taught by Yamashita (Page 11 paragraph; Page 13 paragraph 3) and the third measurement mode requires the same continuous inflation until a threshold heart rate is reached as the second measurement mode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
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