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 .
Response to Arguments
Claims 1 and 5 are amended. Claims 3-4 and 8 are canceled. Claims 1-2, 5-7 and 9 are pending.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 02/25/2026 have been fully considered but they are not persuasive.
Regarding the 35 USC § 101 rejections, Applicant recites under step 2A - prong one, “at least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient or (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient” as a technical and “particular” device; however, as cited in the rejection below, at least the ECG signal sensor is well-understood, routine and conventional in the technology/art, and would not be considered a particular machine, but merely an additional element that is used as an insignificant extra-solution activity for data gathering to simply gather data (ECG signal data) and perform abstract ideas (mental processes) on, and thus at least the ECG signal sensor would not be considered a particular machine. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information (i.e. ECG signals), which is recited as part of a claimed process of analyzing and manipulating the gathered information, see MPEP 2106.05(g).
Under Step A - prong two and 2B, Applicant argues that “…the present application discloses and claims an improvement that leads to more accurate analysis of magnetocardiogram signals”. However, it is important to note that technological improvements cannot be tied to abstract ideas, specifically mental processes in this case. Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include:
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 idea 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. In the instant case, the instant claims are directed to mental processes (i.e. identifying, selecting, executing a process, segmenting, etc.), all of which are performed on generic computer/processing elements that are well-understood, routine and conventional.
Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011). IN the instant case, the claims include the additional elements of a magnetocardiograph sensor or an electrocardiograph sensor, of which are used as insignificant extra-solution activity data gathering by collecting bio-magnetic field and ECG signal data, respectively, to be later analyzed and manipulated by the mental processes as stated above and, in the rejection, below.
Therefore, since the claims are directed mental processes which are performed by conventional computer elements that are well-understood, routine and conventional, AND the claims contain additional elements (sensors) which merely gather data to perform data analysis and are nominal and/or tangential additions to the claim, the claims are not considered to be technical improvements to the technology under step 2A - prong two.
Under step 2B, the claim limitations and amendments as filed are not considered specific limitations other than what is well-understood, routine and conventional activity since the aforementioned sensors (or at least the ECG signal sensor) and the computer elements are considered well-understood, routine and conventional in the technology/art as stated in the rejection below and as shown by Lee (US 20130165805 A1 – hereinafter Lee) and Giftakis (US 20070260147 A1). There are no unconventional steps as well, since the claims as stated before are directed to mental processes but for the recitation of generic computer elements, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper.
Thus, 1-2, 4-7 and 9 are considered to be directed to mental processes without significantly more, and are not patent eligible under 35 USC § 101.
Claim Rejections - 35 USC § 102/103
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, newly cited combination of Zhang (US 20130245478 A1 – hereinafter Zhang) in view of Lee (US 20130165805 A1 – hereinafter Lee) is relied upon to teach independent claims 1 and 9. Previously used reference Lee (US 20130165805 A1 – hereinafter Lee), is relied upon to merely teach the known well-understood, routine and conventional element of an ECG signal sensor as stated in the rejection below.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2021-074247, filed on April 26, 2021.
Information Disclosure Statement
The information disclosure statement(s) filed September 15, 2023 and March 28, 2025 has/have been considered by the Examiner.
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.
Claims 1-2, 5-7 AND 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1-2, 4-7 and 9 recite a biological signal processing system, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A biological signal processing system comprising: at least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient OR (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient; a segment identification unit configured to identify a segment including a time point of a processing target with respect to the magnetocardiogram signal OR the electrocardiogram signal which has a periodic waveform, and has a period corresponding to a cycle that is divided into a plurality of segments in time; a processing control unit configured to select a processing method of processing the magnetocardiogram signal or the electrocardiogram signal at the time point of the processing target on a basis of the segment identified by the segment identification unit; and a process execution unit configured to execute a process on the magnetocardiogram signal or the electrocardiogram signal for the biological signal in the processing method selected by the processing control unit, wherein the segment identification unit includes a segmentation unit configured to divide the period of the magnetocardiogram signal or the electrocardiogram signal into the plurality of segments, and wherein the segmentation unit performs segmentation on a basis of a result of the process executed by the process execution unit as feedback.
Independent claim 9 recites:
A biological signal processing system comprising: a t least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient or (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient; and a processor programmed to: identify a segment including a time point of a processing target with respect to the magnetocardiogram signal or the electrocardiogram signal, which has a periodic waveform, and has a period corresponding to a cycle that is divided into a plurality of segments in time, select a processing method of processing the magnetocardiogram signal or the electrocardiogram signal at the time point of the processing target on a basis of the segment that is identified, execute a process on the magnetocardiogram signal or the electrocardiogram signal in the processing method that is selected, divide the period of the magnetocardiogram signal or the electrocardiogram signal into the plurality of segments, and perform segmentation on a basis of a result of the process that is executed as feedback.
Independent claims 1 and 9 are directed to MENTAL PROCESSES, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a human could mentally identify something by observing something (i.e. processing target segment) and making a mental indication or choice based on the observation. Similarly, a person could mentally select something by observing a list of choices (i.e. processing methods) and making a mental judgement or choice based on the observation. The phrase “execute a process” could be interpreted to simply mean “to process”, in which a human could mentally process something by obtaining and trying to mentally understand new information. A person could mentally perform segmentation by simply looking at a biological/ECG signal and mentally extracting/selecting a desired section of the signal.
Dependent claims 2 and 5-7 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Specifically, dependent claims 2 and 4-7 further define the mental processes of selecting and executing a process, and do not amount to significantly more than the abstract idea itself.
Dependent claims 5-7 contain additional elements of which are well-understood, routine and conventional, and therefore do not amount to significantly more than the abstract idea itself.
Dependent claims 5 contain additional elements and further directed mental processes (i.e. “perform segmentation”, “identify a cycle”, “estimate”, etc.).
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-2, 4-7 and 9 do not disclose using the result of the mental process steps (i.e. identifying, selecting, etc.), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, radiation therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps of identifying, selecting, executing a process and segmenting signals. There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to a form of data processing. Accordingly, claims 1-8 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-2, 5-7 and 9 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the elements of a segment identification unit, processing control unit, and process execution unit, but these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes as stated above). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements also include a magnetocardiograph sensor or an electrocardiograph sensor, either of which are merely used as insignificant extra-solution activity, or pre-solution activity for data gathering by way of collecting bio-magnetic field/ECG signals data, and are merely nominal or tangential additions to the claim as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 2 and 4-7 do not further recite additional elements which, as stated above, practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited a segment identification unit, processing control unit, and process execution unit is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry. As shown in the reference as taught by Lee (US 20130165805 A1 – hereinafter Lee), which teaches an R-peak detection apparatus which comprises a controller 802 (Lee figure 8, controller 802) with a segment identification unit (Lee paragraph 0047 – “The R-peak detection apparatus performs segmentation on the ECG signal with respect to the R-peak candidate (S307)”), processing control unit and process execution unit (Lee paragraph 0043 – “The R-peak detection apparatus includes at least one of a high pass filter, a low pass filter, and a band pass filter”; paragraph 0043 – “The R-peak detection apparatus removes noise by performing filtering with respect to the input ECG signal (S302)”) as well as an ECG signal sensor (paragraph 0076 – “The sensor unit 801 senses and receives the ECG signal from a living body”).
Similarly, Giftakis (US 20070260147 A1) teaches a biosignal processing system (abstract – “A medical device system and method for monitoring cardiac signal activity in patients with nervous system disorders. In some embodiments, a brain signal and a cardiac signal are received by a processor…”) which performs segmentation (paragraph 0232 – “In certain embodiments, segmentation of a cardiac signal (e.g., an ECG signal) may be performed based on the timing of a detected neurological event…”), and includes processing/control units (figure 26, control circuit 720 with CPU 732) and ECG signal sensors (paragraph 0100 – “Cardiac monitoring elements 14 may be cardiac leads or other types of sensors or electrodes capable of picking up cardiac signals”).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1-2, 4-7 AND 9 are not patent eligible under 35 USC § 101.
Claim Interpretation
The term(s) “for” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
Claim Rejections - 35 USC § 103
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) 1-2, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20130245478 A1 – hereinafter Zhang) [NEW] in view of Lee (US 20130165805 A1 – hereinafter Lee) [NEW].
Re. claim 1, Zhang teaches a biological signal processing system (abstract – “A system for adaptively processing patient monitoring signals comprises an input processor for acquiring a signal having amplitude representing electrical activity of a patient heart over time”) comprising:
a segment identification unit configured to identify a segment including a time point of a processing target with respect to the magnetocardiogram signal OR the electrocardiogram signal (paragraph 0018 – “Segmentation and processing unit 15 identifies different portions of the conditioned signal from unit 13 associated with different phases of cardiac activity by, inverting the signal to provide an inverted signal, aligning the signal and the inverted signal in amplitude during a cardiac rest portion and identifying one or more of the different portions in response to an intersection point of the signal and the inverted signal”),
which has a periodic waveform (paragraph 0018 – “A surface ECG signal having an amplitude representing electrical activity of a heart over time is acquired from patient 11…”), and has a period corresponding to a cycle (figure 6, ECG signal 603 shows a single cycle) that is divided into a plurality of segments in time (paragraph 0019 – “Following segmentation and filtering, the surface ECG signal is reconstructed into multiple continuous component signals…”; paragraph 0027 – “An ECG signal 603 is segmented and decomposed into different continuous signal components including an, Atrial action potential signal 606, ventricular depolarization potential signal 608, ventricular repolarization potential signal 610 and late cardiac potential signal 612”, all shown in figure 6);
a processing control unit configured to select a processing method of processing the magnetocardiogram signal or the electrocardiogram signal at the time point of the processing target on a basis of the segment identified by the segment identification unit (paragraph 0027 – “The segmentation facilitates selection and use of coefficients-based filters for filtering component signals”);
and a process execution unit configured to execute a process on the magnetocardiogram signal or the electrocardiogram signal in the processing method selected by the processing control unit (paragraph 0027 – “The segmentation facilitates selection and use of coefficients-based filters for filtering component signals”; paragraph 0034 – “Processor 20 in step 914 employs multiple adaptive signal filters for filtering multiple bandwidths of corresponding different portions of the signal using automatic and adaptive filter coefficient control and by continuous filtering of sub-components”),
wherein the segment identification unit includes a segmentation unit (figure 1, segmentation unit 15) configured to divide the period of the magnetocardiogram signal or the electrocardiogram signal into the plurality of segments (paragraph 0027 – “FIG. 6 shows decomposing and segmentation of an original surface ECG signal into different cardiac signal portions and tissue electrophysiological activities. An ECG signal 603 is segmented and decomposed into different continuous signal components including an, Atrial action potential signal 606, ventricular depolarization potential signal 608, ventricular repolarization potential signal 610 and late cardiac potential signal 612”),
and wherein the segmentation unit performs segmentation on a basis of a result of the process executed by the process execution unit as feedback (figure 9, segmentation step 923 is dynamically performed based on the filtered signal quality diagnosis and evaluations step 926; paragraph 0034 – “Processor 29 in step 926 determines quality of the filtered reconstructed signal by measurement of SNR and if the quality exceeds a predetermined threshold, in step 935 stores the filtered reconstructed signal and patient data presented on patient monitor 39 in repository 17 and iteratively repeats the process from step 906. If the quality is below a predetermined threshold, processor 29 in step 923 adaptively adjusts sub-component and reconstruction filter coefficients and segmentation”).
Zhang further teaches in paragraph 0018: “A surface ECG signal having an amplitude representing electrical activity of a heart over time is acquired from patient 11…”, but does not explicitly teach at least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient OR (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient.
Lee teaches a biosignal processing system (Lee paragraph 0024 – “FIG. 9 illustrates an R-peak detection apparatus…”) comprising a segmentation unit (Lee figure 9, segmentation unit 932; paragraph 0084 – “The segmentation unit 932 performs segmentation based on the R-peak candidate to generate at least one segment”),
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And further teaches at least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient OR (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient (Lee paragraph 0076 – “The sensor unit 801 senses and receives the ECG signal from a living body”).
Both Zhang and Lee teach within the field of biosignal processing systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zhang, to incorporate the explicitly stated ECG sensor unit, as taught by Lee, since such modification would predictably result in, for example, gathering ECG data for detecting an R-peak from an electrocardiogram (ECG) signal (Lee paragraph 0003 – “The present invention relates generally to an apparatus and control method for detecting an R-peak from an ElectroCardioGram (ECG), which is an electric signal output from the heart of a living body”).
Re. claim 2, Zhang of the combined invention further teaches wherein the processing method includes one OR more of:
a frequency filtering method of performing a frequency filtering process (Zhang paragraph 0024 – “System 10 filters out noise, such as 50-60 Hz and high frequency noise, using a notch filter and high pass filter (such as a filter with a 200 Hz cut off frequency)”; paragraph 0031 – “A filter may be a band pass filter, high pass filter or low pass filter in response to control of a frequency band”; paragraph 0035),
a calculation method of performing a prescribed calculation process,
and a region extraction method of extracting a region that is the processing target.
Re. claim 9, Zhang teaches a biological signal processing system (abstract – “A system for adaptively processing patient monitoring signals comprises an input processor for acquiring a signal having amplitude representing electrical activity of a patient heart over time”) comprising:
and a processor (paragraph 0018 – “FIG. 1 shows system 10 for adaptively processing patient monitoring signals using an adaptive closed loop-controlled filter”; figure 1, system 10) programmed to:
identify a segment including a time point of a processing target with respect to the magnetocardiogram signal or the electrocardiogram signal paragraph 0018 – “Segmentation and processing unit 15 identifies different portions of the conditioned signal from unit 13 associated with different phases of cardiac activity by, inverting the signal to provide an inverted signal, aligning the signal and the inverted signal in amplitude during a cardiac rest portion and identifying one or more of the different portions in response to an intersection point of the signal and the inverted signal”),
which has a periodic waveform (paragraph 0018 – “A surface ECG signal having an amplitude representing electrical activity of a heart over time is acquired from patient 11…”), and has a period corresponding to a cycle (figure 6, ECG signal 603 shows a single cycle) that is divided into a plurality of segments in time (paragraph 0019 – “Following segmentation and filtering, the surface ECG signal is reconstructed into multiple continuous component signals…”; paragraph 0027 – “An ECG signal 603 is segmented and decomposed into different continuous signal components including an, Atrial action potential signal 606, ventricular depolarization potential signal 608, ventricular repolarization potential signal 610 and late cardiac potential signal 612”, all shown in figure 6),
select a processing method of processing the magnetocardiogram signal or the electrocardiogram signal at the time point of the processing target on a basis of the segment that is identified (paragraph 0027 – “The segmentation facilitates selection and use of coefficients-based filters for filtering component signals”),
execute a process on the magnetocardiogram signal or the electrocardiogram signal in the processing method that is selected (paragraph 0027 – “The segmentation facilitates selection and use of coefficients-based filters for filtering component signals”; paragraph 0034 – “Processor 20 in step 914 employs multiple adaptive signal filters for filtering multiple bandwidths of corresponding different portions of the signal using automatic and adaptive filter coefficient control and by continuous filtering of sub-components”),
divide the period of the magnetocardiogram signal or the electrocardiogram signal into the plurality of segments (paragraph 0027 – “FIG. 6 shows decomposing and segmentation of an original surface ECG signal into different cardiac signal portions and tissue electrophysiological activities. An ECG signal 603 is segmented and decomposed into different continuous signal components including an, Atrial action potential signal 606, ventricular depolarization potential signal 608, ventricular repolarization potential signal 610 and late cardiac potential signal 612”),
and perform segmentation on a basis of a result of the process that is executed as feedback (figure 9, segmentation step 923 is dynamically performed based on the filtered signal quality diagnosis and evaluations step 926; paragraph 0034 – “Processor 29 in step 926 determines quality of the filtered reconstructed signal by measurement of SNR and if the quality exceeds a predetermined threshold, in step 935 stores the filtered reconstructed signal and patient data presented on patient monitor 39 in repository 17 and iteratively repeats the process from step 906. If the quality is below a predetermined threshold, processor 29 in step 923 adaptively adjusts sub-component and reconstruction filter coefficients and segmentation”).
Zhang teaches in paragraph 0018: “A surface ECG signal having an amplitude representing electrical activity of a heart over time is acquired from patient 11…”, but does not explicitly teach at least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient OR (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient.
Lee teaches a biosignal processing system (Lee paragraph 0024 – “FIG. 9 illustrates an R-peak detection apparatus…”) comprising a segmentation unit (Lee figure 9, segmentation unit 932; paragraph 0084 – “The segmentation unit 932 performs segmentation based on the R-peak candidate to generate at least one segment”),
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And further teaches at least one of (i) a magnetocardiograph sensor that is configured to measure a biomagnetic field and detect a magnetocardiogram signal from a patient OR (ii) an electrocardiograph sensor that is configured to measure an electrocardiogram signal from the patient (Lee paragraph 0076 – “The sensor unit 801 senses and receives the ECG signal from a living body”).
Both Zhang and Lee teach within the field of biosignal processing systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zhang, to incorporate the explicitly stated ECG sensor unit, as taught by Lee, since such modification would predictably result in, for example, gathering ECG data for detecting an R-peak from an electrocardiogram (ECG) signal (Lee paragraph 0003 – “The present invention relates generally to an apparatus and control method for detecting an R-peak from an ElectroCardioGram (ECG), which is an electric signal output from the heart of a living body”).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable Zhang (US 20130245478 A1 – hereinafter Zhang) in view of Lee (US 20130165805 A1 – hereinafter Lee), and in further view of Brockway (US 20130289424 A1 – hereinafter Brockway) [previously cited].
Re. claim 5, the combined invention of Zhang and Lee (hereinafter the combined invention) teaches the segment identification unit as stated above in claim 1, but does not explicitly teach a cycle identification unit configured to identify a cycle for the biological signal acquired in real-time, wherein the segment identification unit estimates the time point of the processing target on a basis of the cycle identified by the cycle identification unit.
Brockway teaches a similar system and method for physiological signal processing (Brockway paragraph 0005 – “Various aspects of the present invention are directed to devices, methods and systems involving physiological monitoring and signal processing…”). Brockway further teaches a cycle identification unit configured to identify a cycle for the biological signal acquired in real-time (Brockway paragraph 0045 – “…the computing circuit processes each digitized ECG signal by decomposing the signal into subcomponents, identifying a location of the QRS complex of a cardiac cycle in the ECG signal…”), and wherein the segment identification unit estimates the time point of the processing target on a basis of the cycle identified by the cycle identification unit (Brockway paragraph 0045 – “…the computing circuit processes each digitized ECG signal by decomposing the signal into subcomponents, identifying a location of the QRS complex of a cardiac cycle in the ECG signal, identifying a first time window in the cardiac cycle that includes the QRS complex, and identifying at least one time window in the cardiac cycle that does not include the QRS complex”).
The combined invention and Brockway both teach within the field of biosignal processing systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of the combined invention, to incorporate the cycle identification unit (computer system) AND segment identification unit (computer system) estimating the time point of the processing target on a basis of the cycle identified by the cycle identification unit, as taught by Brockway, since such modification would predictably result in reconstructing a processed denoised biosignal from the received ECG signal (Brockway paragraph 0045 – “The computing circuit then reconstructs a denoised signal from the received ECG signal, using at least two of the identified target subcomponents”), and in turn routinely assess physiological status of a monitored subject (Brockway paragraph 0003 – “Wireless ECG monitoring devices are also routinely used to monitor subjects in human clinical studies and for diagnosis of arrhythmias. Information extracted from the measured signal can be used to assess the physiological status and/or health of a monitored subject as well as the safety and clinical utility of experimental therapies such as pharmaceuticals”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20130245478 A1 – hereinafter Zhang) in view of Lee (US 20130165805 A1 – hereinafter Lee), and in further view of Firoozabadi (US 20180242872 A1 – hereinafter Firoozabadi) [previously cited].
Re. claim 6, Zhang of the combined invention further teaches a display unit configured to display information about a result of the process executed by the process execution unit (Zhang figure 1, patient monitor 39; paragraph 0019 – “The reconstructed signal is stored in repository 17 and provided to patient monitor 39 for display and storage”).
The combined invention of Zhang and Lee (hereinafter the combined invention) does not explicitly teach a display control unit configured to control a display mode of the display unit on a basis of the segment identified by the segment identification unit.
Firoozabadi teaches a similar biological signal processing system (Firoozabadi paragraph 0001 – “The present disclosure generally relates to signal quality of each electrocardiogram (“ECG”) lead in an ECG recording during continuous ECG monitoring of a patient”). Firoozabadi also similarly teaches a display unit (Firoozabadi paragraph 0007 – “One form of the inventions of the present disclosure is a monitoring device (e.g., a ECG monitor or a Holter monitor) employing an electrocardiograph, and an ECG quality controller”; figures 1A-1B and 3 show displays of ECG signal segments),
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configured to display information about a result of the process executed by the process execution unit (Firoozabadi paragraph 0038 - “As shown in FIG. 1A, ECG quality controller 50 executes a high frequency noise evaluation 51a and a low frequency noise evaluation 51b of processed ECG leads 30 for respectively estimating a high-frequency noise level and a low-frequency noise level of each individual ECG lead 30 on an electrocardiogram segmentation basis”);
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And further teaches a display control unit (figure 1a, ECG quality controller 50),
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configured to control a display mode of the display unit on a basis of the segment identified by the segment identification unit (Firoozabadi paragraph 0041 – “For both high/low-frequency noise evaluations 51a and 51b, ECG quality controller 50 controls a display of a signal quality indication for each segment of the electrocardiogram 41 resulting from the respective noise level analysis of each segment of electrocardiogram 41”).
The combined invention and Firoozabadi teach within the field of biological signal processing systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing system of the combined invention, to incorporate the display unit, display unit control and their functions as taught by Firoozabadi as stated above, since such modification would predictably result in, for example, reliable cardiac diagnosis and monitoring (Firoozabadi paragraph 0002), as well as effective evaluation of signal quality (Firoozabadi paragraph 0004).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20130245478 A1 – hereinafter Zhang) in view of Lee (US 20130165805 A1 – hereinafter Lee) and Firoozabadi (US 20180242872 A1 – hereinafter Firoozabadi), and in further view of Dreisbach (US 20150088020 A1 - hereinafter Dreisbach) [previously cited].
Re. claim 7, the combined invention of Zhang, Lee and Firoozabadi (hereinafter the combined invention) teaches the display control unit as stated above in claim 6, but does not explicitly teach wherein the display control unit controls the display mode so that the display unit displays information about the processing method selected by the processing control unit.
Dreisbach teaches a similar system and method for processing a biological signal (Dreisbach abstract – “A system and method for interactive processing of ECG data are presented”). Dreisbach further teaches a display control unit (Dreisbach figure 3, user device 31),
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wherein the display control unit (Dreisbach paragraph 0024 – “The user device 31 can include components conventionally found in general purpose programmable computing devices, such as a central processing unit, memory, input/output ports, network interfaces, and non-volatile storage, although other components are possible”) controls the display mode so that the display unit displays information about the processing method selected by the processing control unit (Dreisbach paragraph 0028 – “The user may filter the selection 34 using a list of ECG digital noise filters provided by application in filter selection menus 36, 38. By selecting the filters in different menus 36, 38, the user can select different sets of filters for filtering the ECG 32”; paragraph 0048 – “A list, such as in the selection menus 36, 38, of a plurality of digital ECG filters for filtering the selection is displayed to the user, with the user being able to select one or more sets of the filters for filtering the selection (step 67)”).
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The combined invention and Dreisbach all teach within the field of biological signal processing systems. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the display control unit of the combined invention, to incorporate the display unit control functions of controlling the display mode so that the display unit displays information about the processing method selected by the processing control unit, as taught by Dreisbach as stated above, since such modification would predictably result in allowing users to select a particular filter for reducing signal noise, and improve signal quality for heart condition diagnosis (Dreisbach paragraph 0005).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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