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 .
Status of Claims
Claims 1-12 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 04/02/2024.. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“an obtaining unit” in claim 1.
“a determination unit” in claims 1 and 5-8
“a reference pulse creation unit” in claim 7
“a measurement unit” in claim 9
“a log output unit” in claim 10
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.
For the limitation of “an obtaining unit” in claim 1, the specification recites “the obtaining unit obtains a plurality of pieces of physiological information related to a subject” ([0008]) and further recites an ECG sensor ([0034]) and SpO2 sensor ([0036]). Thus, the examiner is interpreting the obtaining unit to be a sensor or element that is able to obtain physiological information related to a subject.
For the limitation of “a determination unit” in claims 1 and 5-8, the specification recites “the determination unit determines effectiveness of the plurality of pieces of physiological information” ([0008]) and states “the CPU 210 constitutes a determination unit” ([0060]). Thus, the examiner is interpreting the determination unit to be a CPU that is able to perform a similar function.
For the limitation of “a reference pulse creation unit” in claim 7, the specification recites “the CPU 210 functions as a reference pulse creation unit, and creates a reference template using the heart beat signal and the pulse signal obtained during normal times” ([0106]). Thus, the examiner is interpreting the reference pulse creation unit to be a CPU that is able to perform a similar function.
For the limitation of “a measurement unit” in claim 9, the specification recites “The CPU 210 functions as a measurement unit and measures a delay time from the detection of the QRS (heart beat) to the detection of the pulse” ([0108]). Thus, the examiner is interpreting the measurement unit to be a CPU that is able to perform a similar function.
For the limitation of “a log output unit” in claim 10, the specification recites “the log output unit outputs log information (history) related to the physiological information (step S107). More specifically, the log output unit outputs the log information related to the physiological information” and where a CPU constitutes a log output unit ([0060]). Thus, the examiner is interpreting the log output unit to be a CPU that is able to perform a similar function.
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12 rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception, specifically an abstract idea without significantly more.
Step 1
Claims 1-12 are directed to statutory subject matter as the claims recite a device, a method, and a system.
Step 2A, Prong One
The Examiner has identified the method of claim 11 as the claim that represents the claimed invention for analysis and is similar to the device of claim 1 and the system of claim 12.
Claim 11 recites the limitations of:
A physiological information analysis method comprising:
obtaining a plurality of pieces of physiological information related to a subject;
determining effectiveness of the plurality of pieces of physiological information; and
issuing, when effectiveness of corresponding first physiological information and second physiological information among the plurality of pieces of physiological information matches, predetermined notification according to the effectiveness, and issuing the predetermined notification according to the effectiveness of any physiological information of the first physiological information and the second physiological information when the effectiveness of the first physiological information and the effectiveness of the second physiological information do not match.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation as “mental process” and “disembodied mathematical algorithms and formulas”. The claim limitations in bold above, cover disembodied mathematical algorithms and formulas, as determining an effectiveness of the physiological information can be done by “calculating a cross-correlation between a waveform of the detected pulse and waveform in a reference template” ([0093]) and determining if the effectiveness of the first and second physiological information matching can be done by “calculate[ing] a correlation coefficient for the waveform data of the both pulses, and determines that the both pulses substantially match when the correlation coefficient is equal to or greater than a predetermined first determination threshold” ([0094]). Additionally, determining if the physiological information matches and the issuing a notification can be performed by a doctor either vocally or with pen and paper. Thus, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation as a mental process and mathematical algorithms, then it falls within the “Mental Processes” and “Disembodied Mathematical Algorithms and Formulas” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See also MPEP 2106.04 (a)(2) III C where use of a generic computer to perform a judicial exception has been shown to be abstract. Claims 1 and 12 are also abstract for similar reasons. The dependent claims 2-10 recite additional mathematical steps for the algorithms.
Step 2A, Prong Two
The judicial exception is not integrated into practical application. Claims 1, 11, and 12 only recite the additional limitations “an obtaining unit”, “a determination unit”, and “notification controller”. The determination unit and notification controller appear to be part of a CPU ([0040]) and an obtaining unit which can comprise an ECG sensor ([0034]) and SpO2 sensor ([0036]). These elements merely use generic computer component to evaluate a sensed signal. Merely including instruction to implement an abstract idea on a computer does not integrate a judicial exception into practical application. Claim 6 recites “a mean pulse calculator”, Claim 7 recites “a reference pulse creation unit”, Claim 8 recites “a pulse interval calculator” and a “a pulse interval estimator”, Claim 9 recites “a measurement unit”, and Claim 10 recites “a log output unit”.
These additional elements are recited at a high-level of generality (i.e. most generic computer and medical systems would be known to have these components for general computation, sensing, processing, and output of sensed data), and they amount to no more than mere pre-solution activity of data gathering from a known sensing device. This pre-solution activity of data gathering using electrodes/sensors is well-understood, routing, and conventional in the field of medical sensing and computing technology.
For example, He et al. reference (CN 117838135 A) which discloses “an obtaining unit” (a parameter measurement circuit 112), “a determination unit” ([0073],[0083], and [0093]), “notification controller” ([0107],[0100]), and “a log output unit” (114), Zong et al. reference (US 2012/0078131 A1) which discloses “mean pulse calculator” ([0035]) , “a pulse interval calculator” ([0035]), Clifford (WO 2013/036718 A1) discloses “a reference pulse creation unit” ([0095]-[0098]), Henry et al. (US 2020/0093389 A1) teaches a “a pulse interval estimator” ([0110]), and Xiangling discloses “a measurement unit” (2.2.1),
Step 2B:
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into practical application (Step 2A-Prong Two), the additional elements of “an obtaining unit”, “a determination unit”, “notification controller”, “a mean pulse calculator”, “a reference pulse creation unit”, “a pulse interval calculator”, “a pulse interval estimator”, “measurement unit”, and “a log output unit” , to perform data analysis of senses signals amount to no more than mere instruction to apply the exception using known and generic elements, and then outputting the results using known computing elements (such as a display, screen, monitor, etc.).
Claims 2-10 depend on claim 1. These dependent claims specify the type of data and processing method with no additional structure or details. These additional elements are recited at a high-level of generality (i.e. most generic computer and medical systems would be known to have these components for general computation, sensing, processing, and output of sensed data), and only provide convention, well-known sensing and computing functions that do not add meaningful limits to practicing the abstract idea.
For example, He et al. reference (CN 117838135 A) which discloses “an obtaining unit” (a parameter measurement circuit 112), “a determination unit” ([0073],[0083], and [0093]), “notification controller” ([0107],[0100]), and “a log output unit” (114), Zong et al. reference (US 2012/0078131 A1) which discloses “mean pulse calculator” ([0035]) , “a pulse interval calculator” ([0035]), Clifford (WO 2013/036718 A1) discloses “a reference pulse creation unit” ([0095]-[0098]), Henry et al. (US 2020/0093389 A1) teaches a “a pulse interval estimator” ([0110]), and Xiangling discloses “a measurement unit” (2.2.1).
Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract ide requiring no more than a generic computer to perform generic computer functions that are well- understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05 (d)). In this case, elements of general computer are being used to implement the abstract idea. Therefore, the claims are not patent eligible.
Therefore, Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is
directed to an abstract idea without significantly more.
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.
Claim(s) 1-5 and 11-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by He et al. (CN 117838135 A), hereinafter He.
Regarding claim 1, He discloses a physiological information analysis device ([0006] “a medical device for monitoring a patient’s vital signs parameters”, medical device 100) comprising:
an obtaining unit (a parameter measurement circuit 112) configured to obtain a plurality of pieces of physiological information related to a subject ([0007] “obtain the first physiological signal”, [0009] “a second physiological signal associated with the first physiological signal is obtained”, [0049] “The parameter measurement circuit 112 may include at least one of the following: electrocardiogram signal parameter measurement circuit, blood oxygen parameter measurement circuit, non-invasive blood pressure parameter measurement circuit, invasive blood pressure parameter measurement circuit, respiratory parameter measurement circuit, body temperature parameter measurement circuit, etc.”, [0051]);
a determination unit configured to determine effectiveness of the plurality of pieces of physiological information ([0073] “the processor compares the parameter waveform corresponding to the first physiological signal within a certain time period with a preset reference waveform. When the waveform does not match the preset reference waveform, the processor considers the first physiological signal to meet the first preset condition corresponding to the first alarm.”, [0083] “Determine whether the second physiological signal meets the second preset condition.”, [0093] “when it is determined that the second physiological signal contains second feature information corresponding to the first alarm, determining whether the second feature information matches the template feature information. If so, then the second physiological signal is determined to satisfy the second preset condition”); and
a notification controller configured to issue, when effectiveness of corresponding first physiological information and second physiological information among the plurality of pieces of physiological information matches, predetermined notification according to the effectiveness, and issue the predetermined notification according to the effectiveness of any physiological information of the first physiological information and the second physiological information when the effectiveness of the first physiological information and the effectiveness of the second physiological information do not match ([0100], [0107] “If the first physiological signal is detected to meet the first preset condition corresponding to the first alarm in the first time period, and if the second physiological signal associated with the first physiological signal also meets the second preset condition in the first time period, it indicates that the abnormality of the first physiological signal may be a physiological abnormality caused by changes in the patient's physical condition. At this time, the alarm is immediately output and/or the alarm level is adjusted. If the second physiological signal associated with the first physiological signal does not meet the second preset condition during the first time period, it indicates that the abnormality of the first physiological signal may be a detectable abnormality. In this case, at least one of the following can be performed on the first alarm: masking, delaying output, and adjusting the alarm level.”, [0134]).
Regarding claim 2, He discloses the physiological information analysis device according to claim 1 (as shown above), wherein the plurality of pieces of physiological information are selected from a group including information related to a heart beat, information related to a pulse, and information related to a blood pressure ([0049] “The parameter measurement circuit 112 may include at least one of the following: electrocardiogram signal parameter measurement circuit, blood oxygen parameter measurement circuit, non-invasive blood pressure parameter measurement circuit, invasive blood pressure parameter measurement circuit, respiratory parameter measurement circuit, body temperature parameter measurement circuit, etc.”).
Regarding claim 3, He discloses the physiological information analysis device according to claim 1 (as shown above), wherein the predetermined notification is notification related to asystole or ventricular fibrillation of the subject ([0118] “The first preset condition refers to the alarm condition of the cardiac arrest alarm, that is, the electrocardiogram signal does not contain QRS complex feature information; or, the QRS complex feature information does not match the preset QRS complex feature information, wherein the preset QRS complex feature information refers to the QRS complex feature information detected by the patient under normal conditions.”).
Regarding claim 4, He discloses the physiological information analysis device according to claim 1 (as shown above), wherein the first physiological information is a heart beat signal ([0113]-[0114] “Step S401: Obtain electrocardiogram (ECG) signal. The electrocardiogram (ECG) signal can be a physiological signal directly acquired by an ECG sensor accessory of a medical device, or an ECG signal indirectly acquired by an external device that acquires the signal and then sends it to the medical device.”), the second physiological information is a pulse signal ([0123]-[0124] “Step S405: Obtain the invasive blood pressure signal and/or blood oxygen signal associated with the electrocardiogram signal. When the ECG signal is determined to meet the first preset condition for the corresponding cardiac arrest alarm, the processor controls the acquisition of the invasive blood pressure signal and/or blood oxygen signal associated with the ECG signal.”), and the notification controller issues, when effectiveness of the heart beat signal and effectiveness of the pulse signal match, notification related to asystole of the subject according to the effectiveness, and issues the notification related to asystole of the subject according to the effectiveness of the pulse signal when the effectiveness of the heart beat signal and the effectiveness of the pulse signal do not match (Figure 4, [00113]-[0138] “Step S401: Obtain electrocardiogram (ECG) signal…Step S403: Determine whether the electrocardiogram signal meets the first preset condition for the corresponding cardiac arrest alarm. If yes, proceed to step S405; otherwise, proceed to step S401…Step S405: Obtain the invasive blood pressure signal and/or blood oxygen signal associated with the electrocardiogram signal…Step S407: Determine whether the invasive blood pressure signal and/or the blood oxygen signal meet the second preset condition. If so, proceed to step S409. If not, proceed to step S410…Step S409: Output the cardiac arrest alarm….Step S410: Delay the output of the cardiac arrest alarm; or, disable the cardiac arrest alarm; or, adjust the alarm level of the cardiac arrest alarm.”)
Regarding claim 5, He discloses the physiological information analysis device according to claim 4 (as shown above), wherein as a result of an electrocardiogram analysis on a heart beat of the heart beat signal, when a QRS shape of the heart beat is a predetermined QRS shape, the determination unit determines that the heart beat signal is effective, and determines that the heart beat signal is ineffective when the QRS shape of the heart beat is not the predetermined QRS shape ([0073] “Normally, the processor compares the parameter value corresponding to the first physiological signal within a certain time period with a preset parameter range. When the value exceeds the preset parameter range (e.g., greater than the upper limit or less than the lower limit), the processor considers the first physiological signal to meet the first preset condition corresponding to the first alarm. Alternatively, the processor compares the parameter waveform corresponding to the first physiological signal within a certain time period with a preset reference waveform. When the waveform does not match the preset reference waveform, the processor considers the first physiological signal to meet the first preset condition corresponding to the first alarm.”, [0173] “The first preset condition refers to the alarm condition of the cardiac arrest alarm, that is, the heart rate feature information in the electrocardiogram signal does not match the template heart rate feature information, wherein the template heart rate feature information refers to the heart rate feature information detected by the patient under normal conditions.”, [0175]-[0177]) .
Regarding claim 10, He discloses the physiological information analysis device according to claim 1, further comprising a log output unit (output component 114) configured to output log information related to the plurality of pieces of physiological information when the effectiveness of the plurality of pieces of physiological information does not match ([0057] “The output component 114 can be a display for outputting images, a player for outputting sound, a light-emitting component for outputting light information, or an audio-visual alarm circuit for simultaneously outputting sound and light information”, [0106] “When it is determined that the second physiological signal does not meet the second preset condition in the first time period, the first alarm is prohibited from being output; or, the first alarm is output according to the preset second alarm mode, wherein the preset second alarm mode includes at least one of shielding the first alarm, delaying the output, and adjusting the alarm level, and the preset first alarm mode is different from the preset second alarm mode”).
Regarding claim 11, He discloses a physiological information analysis method ([0006] “embodiments of the present invention provide an alarm method applied to a medical device for monitoring a patient's vital signs parameters”) comprising:
obtaining a plurality of pieces of physiological information related to a subject ([0007] “obtain the first physiological signal”, [0009] “a second physiological signal associated with the first physiological signal is obtained”, [0049] “The parameter measurement circuit 112 may include at least one of the following: electrocardiogram signal parameter measurement circuit, blood oxygen parameter measurement circuit, non-invasive blood pressure parameter measurement circuit, invasive blood pressure parameter measurement circuit, respiratory parameter measurement circuit, body temperature parameter measurement circuit, etc.”, [0051]);
determining effectiveness of the plurality of pieces of physiological information; and issuing, when effectiveness of corresponding first physiological information and second physiological information among the plurality of pieces of physiological information matches, predetermined notification according to the effectiveness ([0073] “the processor compares the parameter waveform corresponding to the first physiological signal within a certain time period with a preset reference waveform. When the waveform does not match the preset reference waveform, the processor considers the first physiological signal to meet the first preset condition corresponding to the first alarm.”, [0083] “Determine whether the second physiological signal meets the second preset condition.”, [0093] “when it is determined that the second physiological signal contains second feature information corresponding to the first alarm, determining whether the second feature information matches the template feature information. If so, then the second physiological signal is determined to satisfy the second preset condition”); and
issuing the predetermined notification according to the effectiveness of any physiological information of the first physiological information and the second physiological information when the effectiveness of the first physiological information and the effectiveness of the second physiological information do not match ([0100], [0107] “If the first physiological signal is detected to meet the first preset condition corresponding to the first alarm in the first time period, and if the second physiological signal associated with the first physiological signal also meets the second preset condition in the first time period, it indicates that the abnormality of the first physiological signal may be a physiological abnormality caused by changes in the patient's physical condition. At this time, the alarm is immediately output and/or the alarm level is adjusted. If the second physiological signal associated with the first physiological signal does not meet the second preset condition during the first time period, it indicates that the abnormality of the first physiological signal may be a detectable abnormality. In this case, at least one of the following can be performed on the first alarm: masking, delaying output, and adjusting the alarm level.”, [0134]).
Regarding claim 12, He discloses a non-transitory computer readable storage medium storing a physiological information analysis program causing a computer to execute processing ([0037] “the present invention provide a readable storage medium storing an interactive program, wherein the interactive program is executed by a processor to perform the above-described alarm management method.”) comprising:
obtaining a plurality of pieces of physiological information related to a subject ([0007] “obtain the first physiological signal”, [0009] “a second physiological signal associated with the first physiological signal is obtained”, [0049] “The parameter measurement circuit 112 may include at least one of the following: electrocardiogram signal parameter measurement circuit, blood oxygen parameter measurement circuit, non-invasive blood pressure parameter measurement circuit, invasive blood pressure parameter measurement circuit, respiratory parameter measurement circuit, body temperature parameter measurement circuit, etc.”, [0051]);
determining effectiveness of the plurality of pieces of physiological information; and issuing, when effectiveness of corresponding first physiological information and second physiological information among the plurality of pieces of physiological information matches, predetermined notification according to the effectiveness ([0073] “the processor compares the parameter waveform corresponding to the first physiological signal within a certain time period with a preset reference waveform. When the waveform does not match the preset reference waveform, the processor considers the first physiological signal to meet the first preset condition corresponding to the first alarm.”, [0083] “Determine whether the second physiological signal meets the second preset condition.”, [0093] “when it is determined that the second physiological signal contains second feature information corresponding to the first alarm, determining whether the second feature information matches the template feature information. If so, then the second physiological signal is determined to satisfy the second preset condition”); and
issuing the predetermined notification according to the effectiveness of any physiological information of the first physiological information and the second physiological information when the effectiveness of the first physiological information and the effectiveness of the second physiological information do not match ([0100], [0107] “If the first physiological signal is detected to meet the first preset condition corresponding to the first alarm in the first time period, and if the second physiological signal associated with the first physiological signal also meets the second preset condition in the first time period, it indicates that the abnormality of the first physiological signal may be a physiological abnormality caused by changes in the patient's physical condition. At this time, the alarm is immediately output and/or the alarm level is adjusted. If the second physiological signal associated with the first physiological signal does not meet the second preset condition during the first time period, it indicates that the abnormality of the first physiological signal may be a detectable abnormality. In this case, at least one of the following can be performed on the first alarm: masking, delaying output, and adjusting the alarm level.”, [0134]).
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(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over He as applied to claim 4 above, in view of Zong (US 2012/0078131 A1), hereinafter Zong .
Regarding claim 6, He discloses the physiological information analysis device according to claim 4 (as shown above). He however fails to explicitly disclose further comprising a mean pulse calculator configured to calculate a mean value of an amplitude of a pulse and a mean value of an interval of the pulse in the pulse signal during a period in which the heart beat signal is effective, wherein the determination unit determines that the pulse signal is effective when an error of the amplitude of the pulse from the mean value of the amplitude and an error of the interval of the pulse from the mean value of the interval respectively fall within predetermined ranges during a period in which the heart beat signal is ineffective, and determines that the pulse signal is ineffective when any one of the errors falls outside a corresponding one of the predetermined ranges.
However, Zong teaches a patient monitor for monitoring an electrocardiographic signal and a secondary physiological signal for reducing false positive asystole detection events (Abstract, [0009]) wherein a mean pulse calculator configured to calculate a mean value of an amplitude of a pulse and a mean value of an interval of the pulse in the pulse signal during a period in which the heart beat signal is effective ([0035] “The PRI generation operation 80 takes the time series of N+1 pulses as input… For each pulse (including, in this example, any forced pulse detection), pulse amplitude and interval information is computed as statistical pulse-to-pulse (PP) interval features and statistical pulse amplitude features analyzed over the N+1 pulses. The PP interval and amplitude statistics can be done in the following way: For the current pulse denoted P, and the N immediately preceding pulses denoted P.sub.i-n, n=1, . . . , N, calculate the following variables:… (ii) mean value of the pulse-to-pulse interval (PPI) denoted PPI.sub.MEAN; (iii) standard deviation of the PPI denoted PPI.sub.SD; (iv) mean value of the N+1 pulse amplitudes denoted PPA.sub.MEAN”) , wherein the determination unit determines that the pulse signal is effective when an error of the amplitude of the pulse from the mean value of the amplitude and an error of the interval of the pulse from the mean value of the interval respectively fall within predetermined ranges during a period in which the heart beat signal is ineffective, and determines that the pulse signal is ineffective when any one of the errors falls outside a corresponding one of the predetermined ranges ([0047] “A single (false) asystole alarm was issued by the ECG-based asystole detector, as indicated by the thick vertical line passing through the three-channel ECG traces. The second-from bottom trace is the concurrently acquired pleth signal, while the bottommost trace is the PRI computed from the pleth signal. The false ECG asystole event was issued due to the reduced amplitude of the ECG signals. However, the pleth signal continued to behave regularly during this ECG asystole event, and the computed PRI remained at 1 indicating a high degree of pulsatile regularity. At the onset of the (false) ECG asystole event, the PRI was larger than the trained Thr=0.5, and so the ECG asystole alarm was rejected (that is, was not validated)”, Figure 5, [0043] “For the illustrative PRI computation example, the validation criterion is suitably a validation threshold denoted Thr--if the PRI is greater than the validation threshold Thr (that is, PRI>Thr), then the asystole alarm generated by the ECG alone is rejected as a false alarm; otherwise, the asystole alarm is accepted as a true alarm at decision block 56, and the human-perceptible asystole alarm 58 is activated.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified He to incorporate the teachings of Zong to have a mean pulse calculator configured to calculate a mean value of an amplitude of a pulse and a mean value of an interval of the pulse in the pulse signal during a period in which the heart beat signal is effective; wherein the determination unit determines that the pulse signal is effective when an error of the amplitude of the pulse from the mean value of the amplitude and an error of the interval of the pulse from the mean value of the interval respectively fall within predetermined ranges during a period in which the heart beat signal is ineffective, and determines that the pulse signal is ineffective when any one of the errors falls outside a corresponding one of the predetermined ranges, as these prior art references are directed to managing cardiac assessment alarms. One would be motivated to do this these values have a high reliability in keeping true ECG asystole alarms while rejecting false asystole alarms, as recognized by Zong ([0023]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over He as applied to claim 4 above, and further in view of Clifford et al. (WO 2013/036718 A1), hereinafter Clifford.
Regarding claim 7, He discloses the physiological information analysis device according to claim 4 (as shown above). He fails to explicitly disclose the device further comprising a reference pulse creation unit configured to create a reference pulse based on a shape of a pulse in the pulse signal during a period in which the heart beat signal is effective, wherein the determination unit determines that the pulse signal is effective when each of shapes of a predetermined number or more of the pulses matches the shape of the reference pulse during a period in which the heart beat signal is ineffective, the predetermined number being equal to or greater than a first threshold, and determines that the pulse signal is ineffective when each of shapes of a number of the pulses matches the shape of the reference pulse, the number being smaller than the first threshold, or there is no pulse whose shape matches the shape of the reference pulse.
However, Clifford teaches a system and method for evaluating physiological signals to determine whether or not a physiological signal corresponds to a medically relevant condition (Abstract) wherein “A PPG beat dynamic template was built based on 30 second PPG signals as described in Li and Clifford 2012, and a correlation coefficient between each PPG beat and the template was calculated… An SQI threshold (SQI^) for each type of alarm was set to accept or reject the PPG as a good quality signal. At first, SQI^ was set strictly to 1 in order to avoid true alarm suppression. The PPG signal with an SQI above SQI^ was considered as a good quality signal and fed into a false alarm suppression procedure as described in Deshmane et al. The Ql.sub.th then decreased gradually and also obeyed a least true alarm suppression rule. The first subset of data was used to evaluate the algorithm in this step… These 21 HRs and corresponding SQI were used to suppress false alarms respectively.” ([0095]-[0098]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified He to incorporate the teachings of Clifford to have a reference pulse creation unit configured to create a reference pulse based on a shape of a pulse in the pulse signal during a period in which the heart beat signal is effective, wherein the determination unit determines that the pulse signal is effective when each of shapes of a predetermined number or more of the pulses matches the shape of the reference pulse during a period in which the heart beat signal is ineffective, the predetermined number being equal to or greater than a first threshold, and determines that the pulse signal is ineffective when each of shapes of a number of the pulses matches the shape of the reference pulse, the number being smaller than the first threshold, or there is no pulse whose shape matches the shape of the reference pulse, as these prior art directed to reducing false alarms. One would be motivated to do this lower false alarm rate while being more robust in the signals and data that it can handle, as recognized by Clifford ([0041], [0048]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over He in view of Zong as applied to claim 4 above, and further in view of Henry et al. (US 2020/0093389 A1), Henry.
Regarding claim 8, He discloses the physiological information analysis device according to claim 4 (as shown above). He fails to explicitly disclose the device further comprising: a pulse interval calculator configured to calculate a mean pulse interval of a pulse in a period in which the heart beat signal is effective; and a pulse interval estimator configured to estimate, based on the mean pulse interval, an appearance timing of the pulse in a period in which the heart beat signal is ineffective, wherein the determination unit determines that the pulse signal is effective when the pulse appears at the appearance timing during the period in which the heart beat signal is ineffective, and determines that the pulse signal is ineffective when the pulse does not appear at the appearance timing.
However Zong teaches a pulse interval calculator configured to calculate a mean pulse interval of a pulse in a period in which the heart beat signal is effective ([0035] “The PRI generation operation 80 takes the time series of N+1 pulses as input… For each pulse (including, in this example, any forced pulse detection), pulse amplitude and interval information is computed as statistical pulse-to-pulse (PP) interval features and statistical pulse amplitude features analyzed over the N+1 pulses. The PP interval and amplitude statistics can be done in the following way: For the current pulse denoted P, and the N immediately preceding pulses denoted P.sub.i-n, n=1, . . . , N, calculate the following variables:… (ii) mean value of the pulse-to-pulse interval (PPI) denoted PPI.sub.MEAN; (iii) standard deviation of the PPI denoted PPI.sub.SD; (iv) mean value of the N+1 pulse amplitudes denoted PPA.sub.MEAN”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified He to incorporate the teachings of Zong to a pulse interval calculator configured to calculate a mean pulse interval of a pulse in a period in which the heart beat signal is effective, as these prior art references are directed to managing cardiac assessment alarms. One would be motivated to do this these values have a high reliability in keeping true ECG asystole alarms while rejecting false asystole alarms, as recognized by Zong ([0023]).
He and Zong, alone or in combination, fail to explicitly teach a pulse interval estimator configured to estimate, based on the mean pulse interval, an appearance timing of the pulse in a period in which the heart beat signal is ineffective, wherein the determination unit determines that the pulse signal is effective when the pulse appears at the appearance timing during the period in which the heart beat signal is ineffective, and determines that the pulse signal is ineffective when the pulse does not appear at the appearance timing.
However, Henry teaches methods and systems methods for continuously monitoring a patient for cardiac electrical abnormalities including atrial fibrillation, asystole, ventricular fibrillation and tachycardia (Abstract) teaches wherein “The ViSi Mobile monitor can measure heart rate from both the ECG and pulse rate from the optical sensor at the base of the thumb. This allows the device to mitigate false Asystole calls on the ECG using pulse rate. The monitor will alarm on Asystole if a normal or ventricular beat is not detected for a specified period of time and if there is not a valid, current pulse rate available. Pulse rate is determined as the median pulse interval in a 15-second moving window. Pulse intervals are calculated as the time difference between fiducial points on successive beats detected in the photoplethysmogram (PPG) signal. The pulse rate algorithm updates pulse rate every 3 seconds. If the number of PPG beats in the 15-second window drops below a minimum of 3 beats, pulse rate will not display a valid value and it will not suppress an Asystole alarm.” ([0110]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified He and Zong to incorporate the teaching of Henry to have a pulse interval estimator configured to estimate, based on the mean pulse interval, an appearance timing of the pulse in a period in which the heart beat signal is ineffective, wherein the determination unit determines that the pulse signal is effective when the pulse appears at the appearance timing during the period in which the heart beat signal is ineffective, and determines that the pulse signal is ineffective when the pulse does not appear at the appearance timing, as these prior art references are directed to reducing false alarms. One would be motivated to do this to reduce false asystole alarm.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over He as applied to claim 4 above, in view of X. He et al., "Method to Determine the Applicability of Multi-Parameter Fusion Analysis," 2019 Computing in Cardiology (CinC), Singapore, 2019, pp. Page 1-Page 4, doi: 10.22489/CinC.2019.066., hereinafter Xianliang.
Regarding claim 9, He discloses the physiological information analysis device according to claim 4 (as shown above).
He fails to explicitly disclose the device further comprising: a measurement unit configured to measure a delay time from detection of a heart beat to detection of a pulse, wherein the notification controller determines that the pulse of the pulse signal corresponds to the heart beat of the heart beat signal when the delay time is equal to or less than a predetermined second threshold, and determines that the pulse of the pulse signal does not correspond to the heart beat of the heart beat signal when the delay time exceeds the predetermined second threshold.
However, Xianliang teaches a method to reduce false alarms by using multi-parameter fusion analysis (Abstract) wherein “abnormal feature sequences are checked and, if present, MPA is excluded. For example, if Page 2 A pulse peak always occurs later in time than the corresponding ECG R peak. The time delay between a pulse peak and the corresponding R peak is called R-peak Pulse-peak Interval (RPI). Whenever an R peak is detected, a delay window is searched for the presence of a pulse peak. The width of this window is set to 100ms to 200ms before a new R peak is detected (details regarding the delay durations are discussed in [10]. If only one PPG peak is detected in the delay window, the pulse peak and the R peak will be grouped; if more than one pulse peak is detected (when signal amplitude is unusually low and interference is severe), a pulse peak will be selected based on the historical trend of RPI…Three types of matches are possible between QRS wave and pulse wave: 1) Each QRS corresponds to a pulse wave, as shown in Figure 3, when the signal quality for both ECG and PPG is good. 2) Every QRS does not have a corresponding pulse wave as shown in Figure 4. Invalid ejection results in the absence of a pulse signal, so that the QRS complex has no corresponding pulse wave in the time window” (pg. 2-3, 2.2.1. Feature Sequence Matching, view Figure 1 and 3-4).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified to He to incorporate the teachings of Xianliang to have: a measurement unit configured to measure a delay time from detection of a heart beat to detection of a pulse, wherein the notification controller determines that the pulse of the pulse signal corresponds to the heart beat of the heart beat signal when the delay time is equal to or less than a predetermined second threshold, and determines that the pulse of the pulse signal does not correspond to the heart beat of the heart beat signal when the delay time exceeds the predetermined second threshold, as these prior art references and the instant application are directed to providing accurate cardiac assessment alerts. One would be motivated to do this to improve the accuracy of alarms, as recognized by Xiangliang (pg. 1, 1. Introduction).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 5712724156. 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.
/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights