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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, Species A, claims 1-11 in the reply filed on 12/16/2025 is acknowledged.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-11 are currently under examination.
Claim Objections
Claims 3-6 are objected to because of the following informalities:
In claim 3, “result output in past” (line 5) should read -result output in the past-
In claim 4, “result output in past” (line 5) should read -result output in the past-
Claims 5-6 are dependent on claim 3, and as such are also objected to.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “decide whether or not to output the predetermined information to the external device on a basis of information received from the external device according to a result output in past”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “result output” is being referred to. Is this the same type of result output from claim 1? Is this any type of result output? Is this simply any output from the external device? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the result output will be interpreted as any type of past output.
Claim 4 recites the limitation “decide whether or not to output the predetermined information to the external device on a basis of information received from the external device according to a result output in past having severity that is same as the determined severity”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “result output” is being referred to. Is this the same type of result output from claim 1? Is this the same type of result output from claim 3? Is this any type of result output? Is this simply any output from the external device? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the result output will be interpreted as any type of past output.
Claim 6 recites the limitation “decide whether or not to output the predetermined information to the external device by using frequency spectrum calculated from the time-series acoustic signals, in a case where information including follow-up observation has been received as a result of output from the external device for severity corresponding to the determined severity”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “result of output” is being referred to. Is this the same type of result output from claim 1? Is this the same type of result output from claim 3? Is this any type of result output? Is this simply any output from the external device? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the result output will be interpreted as any type of past output with severity corresponding to the determined severity.
Claim 10 recites the limitation “receive information indicating a result of diagnosis according to an output result”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “output result” is being referred to. Is this the same type of output result from claim 1? Is this any type of output result from any source? Is this simply any output from the external device? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the output result will be interpreted as any type of result that is output.
Claims 4-6 are dependent on claim 3, and as such are also rejected.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards a judicial exception without significantly more. These claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception or that are sufficient to amount to significantly more than the judicial exception.
Step 1 of the subject matter eligibility test
Claim 1 is directed towards a device, which describes one of the four statutory categories of patentable subject matter.
Step 2A of the subject matter eligibility test
Prong 1: Claims 1 recites the abstract idea of a mental process as follows:
“detect abnormality in lung sounds for each of auscultation positions on a basis of time-series acoustic signals including lung sounds of each of the auscultation positions”, “determine severity of heart failure of a patient on a basis of a detection result of abnormality in the lung sounds of each of the auscultation positions and condition information representing a condition of the patient”, “decide whether or not to output predetermined information…” “…on a basis of a result of the determination”, and “perform output corresponding to a result of the decision”.
The detecting abnormality in lung sounds for each of auscultation positions on a basis of time-series acoustic signals including lung sounds of each of the auscultation positions, determining severity of heart failure of a patient on a basis of a detection result of abnormality in the lung sounds of each of the auscultation positions and condition information representing a condition of the patient, deciding whether or not to output predetermined information on a basis of a result of the determination, and performing output corresponding to a result of the decision can be practically performed by the human mind, with the aid of a pen and paper, but for performance on a generic processor, in a computer environment, or merely using the computer as a tool to perform the steps.
A person of ordinary skill in the art could reasonably detect an abnormality in lung sounds of differing auscultation positions with a generic computer based on being a handed a piece of paper with time series lung sound signals at differing auscultation positions. A person of ordinary skill in the art could reasonably determine of a severity of heart failure with a generic computer based on being handed a piece of paper with condition information and a detection result of an abnormality in lung sounds data. A person of ordinary skill in the art could reasonably mentally decide whether or not to output information with a generic computer based on receiving a piece of paper with a determination result. A person of ordinary skill in the art could reasonably perform an output with a generic computer or verbally based on a determination result.
There is currently nothing to suggest an undue level of complexity in the detecting, determining, deciding, or performing steps. Therefore, a person would be able to practically be able to perform the detecting, determining, deciding, or performing mentally or with the aid of pen and paper.
Prong Two: Claims 1 does not recite additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., a memory with instructions, a processor, an external device) and
For claim 1. The additional elements merely serve to gather data to be used by the abstract idea. The processor, memory, and external device are merely used as a pre-solution step of necessary data gathering to be used by the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing that is performed remains in the abstract realm, i.e. the gathered data is not used for a treatment or meaningful purpose. Additionally, there is no overall improvement to existing technology present. The mental process merely functions on generic computer elements that do not change the functionality of the device itself. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test for Claim 1.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
Memory with instructions, a processor, and external device as disclosed by Fairbrothers (US Pub. No. 20140088988) hereinafter Fairbrothers, “Each computer may be well known to those skilled in the art and may include a display, a central processor, a system memory, and a system bus that couples various system components including the system memory to the central processor unit. The system bus may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus, and a local bus using any of a variety of bus architectures…” (Par. 22) and Haskell (US Pub. No. 20030233252) hereinafter Haskell “Information device 4000 may include well-known components such as one or more network interfaces 4010, one or more processors 4020, one or more memories 4030 containing instructions 4040, and/or one or more input/output ("I/O") devices 4050, all interconnected in a known manner…” (Par. 45)
are all well-understood, routine, and conventional.
Claims 2-11 do not include additional elements, alone or in combination that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) as all of the elements are directed to the further describing of the abstract idea, pre-solution activities, and computer implementation.
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely further describe the abstract idea:
decide whether or not to output the predetermined information on a basis of whether or not the severity determined exceeds an output threshold (Claim 2),
decide whether or not to output the predetermined information on a basis of information received according to a result output by the output unit in past (Claim 3),
decide whether or not to output the predetermined information on a basis of information received according to a result output in past having severity that is same as the determined severity (Claim 4),
decide whether or not to output the predetermined information by using frequency spectrum calculated from the time-series acoustic signals, in a case where information including follow-up observation has been received as a result of output for severity corresponding to the determined severity (Claim 5),
decide whether or not to output the predetermined information on a basis of a comparison result between frequency spectrum calculated from the time-series acoustic signals used for the detection and frequency spectrum calculated from past time-series acoustic signals (Claim 6),
the predetermined information includes the determined severity and the time-series acoustic signals used for the detection (Claim 7),
the predetermined information includes at least one of information representing weight of the patient and information representing medication (Claim 8),
the predetermined information includes frequency spectrum calculated from the time-series acoustic signals used for the detection (Claim 9),
receive information indicating a result of diagnosis according to an output result (Claim 10).
Further describe the pre-solution activity (or structure used for such activity):
External device (Claim 2, 3, 4, 5, 6, and 11)
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
The external device as disclosed by Fairbrothers and Haskell above
are all well-understood, routine, and conventional.
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, data gathering, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements improves the functioning of a mobile device, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
The claims are generally directed towards an analysis device with a memory and processor. The device is configured to detect abnormality in lung sounds in auscultation positions, determine a severity of heart failure based on the lung sounds, and output the corresponding result based on the severity.
Claim(s) 1-3 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US Pub. No. 20070073168) hereinafter Zhang, and further in view of Hassan (US Pub. No. 20180303413) hereinafter Hassan.
Regarding claim 1, Zhang discloses An analysis device comprising (Abstract (System)) (Par. 15-16 (Respiration circuitry to collect information)) (Fig. 9):
at least one memory (Par. 15- 17 (memory and processor)); and
at least one processor (Par. 15-17 (processor and memory)):
detect abnormality in lung sounds for each of auscultation positions on a basis of time-series acoustic signals including lung sounds of each of the auscultation positions (Fig. 9)(Par. 96 (acquisition of respiration data from devices 902 and 903 at differing positions)) (Par. 97, “the implantable device 902 (or external device 903) incorporates or is coupled to a respiratory rate processor 904. The RR processor 904 processes sensed respiratory activity and computes a respiration rate of the patient. The RR data is communicated from the RR processor 904 to a .DELTA.RR circuit 905. The .DELTA.RR circuit 905 compares the RR data to a preestablished threshold, and generates a threshold signal when the patient's RR exceeds the threshold…”) (Par. 48-49 (respiration signals from sensors));
determine severity of heart failure of a patient on a basis of a detection result of abnormality in the lung sounds of each of the auscultation positions (Par. 97 (respiration data above threshold)) (Par. 96 (acquisition of respiration data from devices 902 and 903 at differing positions)) (Par. 48-49 (respiration signals from sensors)) and condition information representing a condition of the patient (Fig. 9)(Par. 98, “In the embodiment shown in FIG. 9, a weight scale 906 is available and used to acquire patient weight. The measured patient weight is communicated (electronically or via manual input) to a .DELTA.weight circuit 908. The .DELTA.weight circuit 908 compares the weight data to a preestablished threshold, and generates a threshold signal when the patient's weight exceeds the threshold relative to the patient's baseline weight 909…” (weight condition information)) (Par. 99, “The response module 910 receives threshold signals from the .DELTA.RR circuit 905 and .DELTA.weight circuit 908. The response module 910 may also receive raw and/or processed respiratory and weight data respectively from the .DELTA.RR and .DELTA.weight circuits 905, 908. The response module 910 may be implemented to provide various output signals and functionality. The response module 910, for example, may generate a signal indicative of the patient's CHF status, progression, and/or predicted status/progression based on the outputs from the .DELTA.RR and .DELTA.weight circuits 905, 908.” (CHF status based on respiratory data and weight data)) (Par. 43-47, 51 (respiratory parameters and CHF)) (Par. 52 (CHF based on weight and respiratory parameters)); and
decide whether or not to output predetermined information on a basis of a result of the determination (Par. 99, “The response module 910 may be implemented to provide various output signals and functionality. The response module 910, for example, may generate a signal indicative of the patient's CHF status, progression, and/or predicted status/progression based on the outputs from the .DELTA.RR and .DELTA.weight circuits 905, 908. The response module 910 may also generate a signal that is used by a therapy processor 912 to initiate, adjust, or terminate a therapy delivered to the patient, such as a diuretics therapy. The response module 910 may also generate a signal that is received by an alert/alarm module 914. Alert/alarm module 914 produces a perceivable alert that indicates the patient requires clinician attention or intervention in response to the generated signal.”), and perform output corresponding to a result of the decision (Par. 99, “…The response module 910 may also generate a signal that is used by a therapy processor 912 to initiate, adjust, or terminate a therapy delivered to the patient, such as a diuretics therapy. The response module 910 may also generate a signal that is received by an alert/alarm module 914. Alert/alarm module 914 produces a perceivable alert that indicates the patient requires clinician attention or intervention in response to the generated signal.”) (Par. 41, “the present invention is directed to systems and methods for detecting changes in respiratory disturbances and changes in congestive heart failure status of a patient. Respiratory disturbances, such as rapid shallow breathing, may be monitored using an implantable or patient-external device or sensing arrangement. RSB events may be detected and monitored, and trends in RSB events may be used to detect or indicate changes in a patient's CHF status. Detection of such changes may be used to initiate, adjust or terminate therapy delivery to the patient (via manual or automatic means), or to indicate need for interventional action by the patient or clinician (e.g., an alert/alarm or call to physician).”).
Zhang fails to explicitly disclose at least one memory configured to store instructions; at least one processor configured to execute instructions.
However, Zhang does disclose at least one memory (Par. 15-17 (memory));
at least one processor (Par. 15-17 (processor)).
Zhang and Hassan are considered to be analogous art to the claimed invention as they are involved with measurement and analysis of patient data.
Hassan teaches at least one memory configured to store instructions (Par. 77, “As shown, a system 200 may include a UCD 210 that may include an analysis unit 211. Analysis unit 211 may be, or may include, a controller 105, a memory 120 and executable code 125 as described herein…”) (Par. 40 (memory and instructions));
at least one processor configured to execute instructions (Par. 45, “Controller 105 (or one or more controllers or processors, possibly across multiple units or devices) may be configured to carry out methods described herein, and/or to execute or act as the various modules, units, etc. More than one computing device 100 may be included in, and one or more computing devices 100 may be, or act as the components of, a system according to some embodiments of the invention.”)(Par. 77, “As shown, a system 200 may include a UCD 210 that may include an analysis unit 211. Analysis unit 211 may be, or may include, a controller 105, a memory 120 and executable code 125 as described herein…”)(Par. 52 (processor and controller)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang with that of Hassan to explicitly include at least one memory configured to store instructions; at least one processor configured to execute instructions through the combination of references as differing computational structures and implementations are known in the art (Hassan (Par. 43, 52)), and it would have yielded the predictable result of providing the exact computational structures needed for the device.
Modified Zhang fails to explicitly disclose output to an external device.
However, Zhang does teach in an alternate implementation remote monitoring by a physician (Par. 111, “PIMD 1200 may be implemented to communicate with a patient management server or network 1234 via an appropriate communications interface or an external programmer 1230. A PIMD 1200 of the present invention may be used within the structure of an advanced patient management (APM) system. The advanced patient management system allows physicians to remotely and automatically monitor cardiac and respiratory functions, as well as other patient conditions…”).
Hassan further teaches output to an external device (Par. 104, “Analysis unit 211 may perform any action based on a classification or examination of recorded respiration. For example, based on comparing a respiration characteristics vector representing a current condition of a user to a user respiration profile 131 that represents a normal (or known) condition of the user and determining a breach of at least one threshold, analysis unit 211 may: send a message to a predefined list of recipients (e.g., a physician of the patient, a medical institution, a family relative and the like); sound an alarm (e.g., using a speaker in UCD 210), present a warning message (e.g., using a display of UCD 210) or perform any other action. An alarm generated by UCD 210 may be or may include, for example, a presentation of text and/or an image on a display of UCD 210, using a speaker of UCD 210 to sound an alarm, using a vibration unit included in UCD 210 to vibrate UCD 210 and the like.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Hassan to explicitly include output to an external device through the combination of references as it would have yielded the predictable result of providing information directly to a physician (Hassan (Par. 104)) and improve treatment quality.
Regarding claim 2, modified Zhang highly suggests but fails to explicitly disclose the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information to the external device on a basis of whether or not the severity determined exceeds an output threshold (Examiner's Note: Zhang fails to explicitly disclose the threshold).
However, Zhang does disclose the at least one processor (Zhang (Par. 15-17 (processor)) (Fig. 9) is configured to execute the instructions to decide whether or not to output the predetermined information to the external device on a basis of the severity determined (Par. 99, “The response module 910 may be implemented to provide various output signals and functionality. The response module 910, for example, may generate a signal indicative of the patient's CHF status, progression, and/or predicted status/progression based on the outputs from the .DELTA.RR and .DELTA.weight circuits 905, 908. The response module 910 may also generate a signal....”) (Par. 41, “the present invention is directed to systems and methods for detecting changes in respiratory disturbances and changes in congestive heart failure status of a patient. Respiratory disturbances, such as rapid shallow breathing, may be monitored using an implantable or patient-external device or sensing arrangement. RSB events may be detected and monitored, and trends in RSB events may be used to detect or indicate changes in a patient's CHF status. Detection of such changes may be used to initiate, adjust or terminate therapy delivery to the patient (via manual or automatic means), or to indicate need for interventional action by the patient or clinician (e.g., an alert/alarm or call to physician).”).
Zhang does teach generating an alarm based on status (Par. 99, “The response module 910 may be implemented to provide various output signals and functionality. The response module 910, for example, may generate a signal indicative of the patient's CHF status, progression, and/or predicted status/progression based on the outputs from the .DELTA.RR and .DELTA.weight circuits 905, 908. The response module 910 may also generate a signal that is used by a therapy processor 912 to initiate, adjust, or terminate a therapy delivered to the patient, such as a diuretics therapy. The response module 910 may also generate a signal that is received by an alert/alarm module 914. Alert/alarm module 914 produces a perceivable alert that indicates the patient requires clinician attention or intervention in response to the generated signal.”) (Par. 41, “the present invention is directed to systems and methods for detecting changes in respiratory disturbances and changes in congestive heart failure status of a patient. Respiratory disturbances, such as rapid shallow breathing, may be monitored using an implantable or patient-external device or sensing arrangement. RSB events may be detected and monitored, and trends in RSB events may be used to detect or indicate changes in a patient's CHF status. Detection of such changes may be used to initiate, adjust or terminate therapy delivery to the patient (via manual or automatic means), or to indicate need for interventional action by the patient or clinician (e.g., an alert/alarm or call to physician).”).
Hassan further teaches severity determined exceeds an output threshold (Par. 63, “Of course, a severity score may be based on the magnitude of a breach of a threshold, e.g., a first severity score may be determined if a breath rhythm increases by 10% with respect to a previously measured breath rhythm or with respect to a breath rhythm in user respiration profile 131 and a second, higher severity score may be determined if the breath rhythm increases by 25%. A severity score may be sent to a server (e.g., analysis unit 211 may send a severity score to analysis unit 251) and, an alert or alarm may be generated and sent or provided if the severity score is above a predefined threshold, e.g., analysis unit 251 may send an alert message as described.”) (Par. 84, “If, based on a condition, state, trend or progress of a medical condition determined as described, a breach of a threshold is identified, a deterioration of a medical condition is determined or an undesirable trend is detected, an embodiment may perform one or more actions, e.g., generate an alarm as described”) (Par. 62, “if a score or rank calculated as described is above a threshold score or value then an action may be performed, e.g., if a score calculated by analysis unit 211 as described is above a threshold then analysis unit 211 may generate an alarm, alert the user and/or a physician, send a message to server 250 or perform any action as described here”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Hassan to explicitly include the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information of Zhang to the external device of Hassan on a basis of whether or not the severity determined exceeds an output threshold through the combination of references and explicitly including an output threshold as it would have yielded the same or similar result of alerting a physician (Hassan (Par. 62)).
Regarding claim 3, modified Zhang fails to explicitly disclose wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information to the external device on a basis of information received from the external device according to a result output in past.
However, Zhang does disclose wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information to the external device (as indicated in claim 1 above).
Hassan further teaches output on a basis of information received from the external device according to a result output in past (Par. 57 (patient data in storage used by the server)) (Par. 62-63 (output based on previous data)) (Par. 59 (analysis units)) (Par. 68, “Thresholds, rules and/or criteria in ranking data 133 may be automatically and/or dynamically modified. For example, if or when an alarming condition is identified as described, analysis unit 211 may automatically modify thresholds, rules and/or criteria in ranking data 133…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Hassan to explicitly include wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information of Zhang to the external device of Hassan on a basis of information received from the external device according to a result output in past through the combination of references as it would have yielded the predictable result of factoring in historical data and improving the quality of the model.
Regarding claim 10, modified Zhang further discloses wherein the at least one processor is configured to execute the instructions to receive information indicating a result of diagnosis according to an output result (Zhang (Par. 99 (CHF status and progression)) (Par. 100 (generation of statistics))).
Regarding claim 11, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Hassan further teaches further discloses wherein the external device is a device used by a home doctor (Par. 104, “Analysis unit 211 may perform any action based on a classification or examination of recorded respiration. For example, based on comparing a respiration characteristics vector representing a current condition of a user to a user respiration profile 131 that represents a normal (or known) condition of the user and determining a breach of at least one threshold, analysis unit 211 may: send a message to a predefined list of recipients (e.g., a physician of the patient, a medical institution, a family relative and the like); sound an alarm (e.g., using a speaker in UCD 210), present a warning message (e.g., using a display of UCD 210) or perform any other action. An alarm generated by UCD 210 may be or may include, for example, a presentation of text and/or an image on a display of UCD 210, using a speaker of UCD 210 to sound an alarm, using a vibration unit included in UCD 210 to vibrate UCD 210 and the like.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Hassan to explicitly include wherein the external device is a device used by a home doctor for the reasoning as indicated in claim 1 above.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Hassan as applied to claim 3 above, and further in view of Murai (US Pat. No. 11583189) hereinafter Murai.
Zhang and Hassan teach the device of claim 3 above.
Regarding claim 4, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Zhang does disclose decide whether or not to output the predetermined information to the external device (As indicated in claim 1 above).
Hassan further teaches output to the external device on a basis of information received from the external device (Par. 57 (patient data in storage used by the server)) (Par. 60 (analysis units 211 and 251))(Par. 62-63 (output based on previous data)) (Par. 59 (analysis units)) (Par. 68, “Thresholds, rules and/or criteria in ranking data 133 may be automatically and/or dynamically modified. For example, if or when an alarming condition is identified as described, analysis unit 211 may automatically modify thresholds, rules and/or criteria in ranking data 133…”).
Murai teaches according to a result output in past having severity that is same as the determined severity (Claim 1 “A system for monitoring patient status, comprising: at least one sensor that continuously acquires biological data from a patient; a destination display; and a controller configured to set an initial value for a historical patient status, where the historical patient status value indicates a normal, caution, or warning level; continuously receive biological data from the at least one sensor; periodically determine whether there is an alarm state in connection with the received biological data…” “…. (output of information, monitoring patient status)).
Zhang, Hassan, and Murai are considered to be analogous art to the claimed invention as they are involved with measurement and analysis of patient data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Hassan and Murai to explicitly include decide whether or not to output the predetermined information of Zhang to the external device of Hassan on a basis of information received from the external device of Zhang according to a result output in the past having severity that is same as the determined severity through the combination of references as it would have yielded the predictable result of allowing for continuous monitoring (Murai (Claim 1)) and adapt to changing data (Hassan (Par. 68)).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Hassan as applied to claim 3 above, and further in view of Shapiro (US Pat. No. 5957866) hereinafter Shapiro.
Zhang and Hassan teach the device of claim 3 above.
Regarding claim 5, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Zhang does disclose decide wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information to the external device (As indicated in claim 1 above).
Shapiro teaches using frequency spectrum calculated from the time-series acoustic signals (Fig. 5 (step 208)) (Col. 5-6, lines 59-15 (frequency spectrum of sound data)), in a case where information including follow-up observation has been received as a result of output from the external device for severity corresponding to the determined severity (Col. 6, lines 16-24) (Fig. 5, step – 214 (suggestion of maneuvers that returns back to the beginning)).
Zhang, Hassan, and Shapiro are considered to be analogous art to the claimed invention as they are involved with measurement and analysis of patient data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Shapiro as referenced by Hassan to explicitly include wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information of Zhang to the external device of Hassan by using frequency spectrum calculated from the time-series acoustic signals of Zhang, in a case where information including follow-up observation has been received as a result of output from the external device for severity corresponding to the determined severity through the combination of references as differing patient data types are known in the art (Hassan (Par. 58)) as it would have yielded the predictable result of improving data quality and providing direct physician feedback for data collection (Shapiro (Col. 6, lines 16-24)).
Regarding claim 6, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Zhang does disclose wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information to the external device (as indicated in claim 1 above).
Shapiro further teaches on a basis of comparison result between frequency spectrum calculated from the time-series acoustic signals used for the detection and frequency spectrum calculated from past time-series acoustic signals (Col. 6, lines 16-24).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang, Hassan, and Shapiro with that of Shapiro as referenced by Hassan to explicitly include wherein the at least one processor is configured to execute the instructions to decide whether or not to output the predetermined information of Zhang to the external device of Hassan on a basis of a comparison result between frequency spectrum calculated from the time-series acoustic signals used for the detection and frequency spectrum calculated from past time-series acoustic signals through the combination of references as differing patient data types are known in the art (Hassan (Par. 58)) as it would have yielded the predictable result of improving data quality and compensating for background noise (Shapiro (Col. 5-6, lines 59-15)).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Hassan as applied to claim 1 above, and further in view of Karankevich (US Pub. No. 20210145306) hereinafter Karankevich.
Zhang and Hassan teach the device of claim 1 above.
Regarding claim 7, modified Zhang further discloses wherein the predetermined information includes the determined severity (Zhang (Par. 99 (signals provided))(Par. 100 (respiratory parameters))).
Zhang fails to explicitly disclose wherein the predetermined information includes the time-series acoustic signals used for the detection (Examiner's Note: Zhang fails to explicitly disclose the presentation of time-series acoustic signals).
However, Karankevich teaches wherein the predetermined information includes the time-series acoustic signals used for the detection (Par. 32, “Respiratory information is both acquired from subjects and presented to interested parties in a variety of ways as functions of the respiratory condition technology. To a great extent, the acquisition and presentation of respiratory information is effected through user interfaces of applications running on smart phones, tablets, other mobile devices, computers, and other user devices that can be considered part of the respiratory condition technology...”) (Par. 33, “Parts of the respiratory information, including respiratory sound data, respiratory sound classes, and respiratory conditions, are acquired, analyzed, processed, and presented in components of the respiratory condition technology, which can include servers and user devices, for example. When presented to interested parties, for example through user interfaces of mobile devices and other devices, respiratory information can take any presentation form, including text, sounds, tables, charts, images, graphs, video, and combinations of them.”)(Par. 30 (respiratory information)) (Par. 25-27 (respiratory sound data)).
Zhang, Hassan, and Karankevich are considered to be analogous art to the claimed invention as they are involved with measurement and analysis of patient data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang and Hassan with that of Karankevich to include wherein the predetermined information of Zhang includes the determined severity and the time-series acoustic signals used for the detection through the combination of references as differing data types are known in the art (Karankevich (Par. 30)) and it would have yielded the predictable result of providing additional data to the user (Karankevich (Par. 32-33)).
Regarding claim 8, modified Zhang fails to explicitly discloses the limitations of the claim.
However, Zhang does disclose information includes at least one of information representing weight of the patient (Par. 99 (signals provided that are representative of the weight))(Par. 100 (respiratory parameters)) and information representing medication.
Karankevich further teaches predetermined information includes at least one of information representing weight of the patient (Par. 27, “Respiratory sound data comprises only one kind of respiratory information. Other kinds of respiratory information can be subjective or objective and can include text, image, video, and numeric information about the respiratory system including age, weight, geographic location, medical history, lifestyle…”) (Par. 32, “Respiratory information is both acquired from subjects and presented to interested parties in a variety of ways as functions of the respiratory condition technology. To a great extent, the acquisition and presentation of respiratory information is effected through user interfaces of applications running on smart phones, tablets, other mobile devices, computers, and other user devices that can be considered part of the respiratory condition technology...”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang, Hassan, and Karankevich with that of Karankevich to include predetermined information of Zhang includes at least one of information representing weight of the patient for the reasoning as indicated in claim 7 above.
Regarding claim 9, modified Zhang fails to explicitly disclose the limitations of the claim.
Zhang discloses the predetermined information (as indicated in claim 1 above).
However, Karankevich further teaches the predetermined information includes frequency spectrum calculated from the time-series acoustic signals used for the detection (Par. 37, “The sound processor 212 can perform a variety of signal processing functions including noise reduction using, for example, forward and inverse wavelet transforms, frequency filtering using, for example, a finite impulse response filter (FIR filter), signal normalization, elimination of constant amplitude offset (DC offset), time-frequency representation charting, such as Mel spectrogram calculation, and other techniques, and combinations of them…”)(Par. 32, “Respiratory information is both acquired from subjects and presented to interested parties in a variety of ways as functions of the respiratory condition technology. To a great extent, the acquisition and presentation of respiratory information is effected through user interfaces of applications running on smart phones, tablets, other mobile devices, computers, and other user devices that can be considered part of the respiratory condition technology...”). (Examiner's Note: The frequency spectrum is not used as an input for the determination of severity)
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhang, Hassan, and Karankevich with that of Karankevich to include predetermined information includes frequency spectrum calculated from the time-series acoustic signals used for the detection through the combination of references as differing data types are known in the art (Karankevich (Par. 30)) and it would have yielded the predictable result of providing improved signal quality as output.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. 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, Jason Sims can be reached at (571) 272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARI S PADDA/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791