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 Group III (claims 13-20, 22 and 23) in the reply filed on 2/4/2026 is acknowledged. Claims 4-12 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 13-20 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more. Claim 1 recites “generate audio indicative of a pulse of the subject by analyzing the sound indicative of cardiac activity of the subject” which is considered a mental process that relates to the analysis of data, e.g. listening/analyzing a sound which is then reproduced. This judicial exception is not integrated into a practical application because the additional elements of a first sensor, second sensor, processor, speaker and display all relate to insignificant extra-solution activities and/or merely using a computer as a tool to perform an abstract idea. Specifically, the sensors are generic sensors that are used for data collection, the processor is a generic processor that merely performs the abstract idea/mental process and the speaker and display are generic computer tools used to output/display the results. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are all well-understood, routine and conventional elements recited in a merely generic manner or as insignificant extra-solution activity, specifically to collect data, perform an analysis of this data and to output the results of the analysis. The examiner would like to emphasize that any/all displays are configured to/capable of outputting a visual signal simultaneously as a speaker is outputting audio. Stated differently, this limitation is merely a functional limitation/intended use of a normal display, and any/all generic displays have the necessary structural components to be capable of providing this function; see MPEP 2114. Therefore, the claimed display is not a particular machine, but instead a generic/common display/monitor (or known computer tool) used merely to output results of the analysis/mental process. The same is true for the speaker, as this is a generic computer tool used to output a result of the analysis. Similarly, the sensors are just common/routine sensors that are used merely to collect the necessary data that is then used in the analysis, i.e. mental process. These sensors are arranged and used in their conventional manner to obtain/collect data. Lastly, the processor is a generic computer that is used merely as a tool to carry out or “apply” the abstract idea.
Regarding claims 14, 15 and 17, these claims relate to inherent properties, characteristics or scientific explanations of how generic audio/acoustic/ultrasound sensors operate to provide/determine an “audio indicative of the pulse of a subject”, e.g. a heartbeat or blood flow. Therefore, these limitations do not relate to a particular machine, but instead relate to generic/common sensors that are known to obtain sound/acoustic signals from a patient, e.g. microphone or ultrasound, and are therefore considered insignificant extra-solution activity, i.e. mere data collection.
Regarding claim 16, these limitations relate solely to the mental process, as these steps of determining, comparing and defining can be done in a person’s mind.
Regarding claim 18, this claim recites generic types of conventional sensors that are used in extra-solution activity, i.e. data collection.
Regarding claim 19, this limitation does not further limit any of the additional elements, as it relates to an event/condition experienced by the user, e.g. if a user is experiencing an arrhythmia, the resulting sound from the sensor will inherently be indicative of such an arrhythmia/condition.
Regarding claim 20, similar to claim 16 above, these claims serve to further limit the abstract idea itself and relate solely to steps that can be done in a user’s head.
Regarding claim 22, the examiner takes the position that a housing and adhesive to attach a sensor to a user’s body is well-understood, routine and conventional within the art in order to obtain physiological data from the user’s body in a secure/efficient manner.
Regarding claim 23, it is noted that this claim is not rejected under 101 as it requires a specific prophylaxis, i.e. electrical shock, and is therefore a practical application of the abstract idea.
Claim Rejections - 35 USC § 102
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.
Claims 13, 14, 17-19 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0054008 to Venkatraman et al.
[Claims 13 and 18] Venkatraman discloses a medical device (Fig. 1), comprising:
a first sensor (audio sensors 122) configured to detect, during a time interval, a sound indicative of cardiac activity of a subject (“heart sound”; at least Pars 0034 and 0050;
a second sensor (ECG sensors 124, pulse oximeter 176, blood pressure monitor 177, temperature monitor 178 and/or other peripheral monitoring devices 179) configured to detect, during the time interval, a physiological parameter of the subject (at least Pars 0033 and 0038);
a processor (transmitting device 132 including processor 142) configured to generate audio indicative of a pulse of the subject by analyzing the sound indicative of cardiac activity of the subject (at least Par 0041; a heart sound is audio indicative of a pulse);
a speaker (“a sound rendering device (e.g., ear phone, speaker, etc.) coupled to the transmitting device” Par 0041) configured to output the audio indicative of the pulse of the subject; and
a display (user interface 148) configured to output a visual signal indicating the physiological parameter of the subject detected during the time interval, the display outputting the visual signal simultaneously as the speaker is outputting the audio indicative of the pulse of the subject (“Simultaneously, the audio and ECG sensor data may be rendered via a display portion of user interface 148 and a sound rendering device (e.g., ear phone, speaker, etc.) coupled to the transmitting device.” Par 0041; see also 310, Fig. 3 and Pars 0040, 0081 and 0095)
[Claims 14 and 17] These claim limitations are related to the inherent properties, characteristics and scientific explanations as to how sound works, and more specifically relates to how heart sounds are obtained via audio sensors 122; see MPEP 2112. In particular, a heart sound is a reflection of an incident beam from a wall of the heart and/or blood flowing through the heart. Additionally or alternatively, the audio sensors (122) are inherently capable of providing the claimed function; see MPEP 2114.
[Claim 19] This is considered a contingent limitation, specifically based on whether or not the patient (to which the first/audio sensor is attached) is currently undergoing an arrhythmia, i.e. abnormal heart rhythm that is too fast, too slow or irregular. The examiner contends that the heart sound outputted by the speaker is indicative of an arrhythmia if/when the patient is undergoing an arrhythmia, as the outputted heart sound will either be too fast, too slow or irregular. Therefore, the contingent limitation is met; see MPEP 2111.04.
[Claim 23] This claim further limits an optional limitation, i.e. ECG, of claim 18. MPEP 2143.03 states “Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation.” Therefore, since the ECG is recited in the alternative, i.e. optional, the limitations recited in claim 23 that further limit this optional limitation are also optional. Therefore, that fact that Venkatraman discloses pulse oximetry data (at least Par 0145), i.e. blood oxygenation, as the physiological parameter meets the claim language of claim 23. If applicant disagrees, see alternative 103 below.
Claims 13-15, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0245651 to Nakamura.
[Claim 13] Nakamura discloses a medical device (Fig. 1), comprising:
a first sensor (sound data obtaining unit 20) configured to detect, during a time interval, a sound indicative of cardiac activity of a subject (sound data 120, specifically “heart sounds”; at least Pars 0047 and 0066);
a second sensor (volume data obtaining unit 10) configured to detect, during the time interval, a physiological parameter of the subject (three-dimensional volume data 100 and three-dimensional volume data group 110; at least Pars 0041-47);
a processor (medical playback device 1, including synchronizing unit 40 and playback control unit 50; Pars 0026, 0039 and claim 9 disclose a computer/processor) configured to generate audio indicative of a pulse of the subject by analyzing the sound indicative of cardiac activity of the subject (at least 0047-55; a heart sound is audio indicative of a pulse);
a speaker (4A) configured to output the audio indicative of the pulse of the subject (Pars 0055 and 0061); and
a display (4) configured to output a visual signal indicating the physiological parameter of the subject detected during the time interval (Figs. 5 and 7), the display outputting the visual signal simultaneously as the speaker is outputting the audio indicative of the pulse of the subject (Pars 0055 and 0061. Furthermore, it is noted that any/all displays are configured, i.e. include all of the necessary structural components, to be capable of outputting any visual signal at any desired time; MPEP 2114)
[Claims 14, 15 and 17] These claim limitations relate to the inherent properties and scientific explanation as to how sound, specifically ultrasound is used to determine heart sounds and blood flow. Nakamura specifically discloses using ultrasound as the first/audio sensor (Par 0066).
[Claim 19] This is considered a contingent limitation, specifically based on whether or not the patient (to which the first/audio sensor is attached) is currently undergoing an arrhythmia, i.e. abnormal heart rhythm that is too fast, too slow or irregular. The examiner contends that the heart sound outputted by the speaker is indicative of an arrhythmia if/when the patient is undergoing an arrhythmia, as the outputted heart sound will either be too fast, too slow or irregular. Therefore, the contingent limitation is met; see MPEP 2111.04.
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nakamura as applied to claim 14 above, and further in view of US 3,658,060 to Eklof.
Nakamura is discussed above, including using Doppler ultrasound techniques to determine blood flow information (Par 0066). As made clear by applicant’s own specification, Doppler ultrasound techniques inherently require comparing a frequency of the reflection of an incident beam to a frequency of the incident beam to determine the velocity of heart wall and blood flowing therethrough. However, Nakamura is silent to defining a pitch or volume of the outputted sound/audio to be proportional to this blood flow or pulse. However, in the same field of endeavor, Eklof discloses an audible cardiac monitor where “the pitch of the audio signal is proportional to blood pressure deviation from the normal and any rhythmic variation in pitch is proportional to heart beat rate.” (At least Abstract). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Nakamura to define the heart sound output by the speaker to be proportional to the heart beat or blood flow to serve as a known audible indicator/alarm/monitor of patient’s cardiac condition, as taught by Eklof.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Venkatraman or Nakamura as applied to claim 13 above, and further in view of US 3,658,060 to Eklof.
Venkatraman and Nakamura are discussed above, but fail to teach determining a difference between a rate of the pulse and a reference value, e.g. a normal value or threshold, and generating audio proportional to this difference. However, in the same field of endeavor, Eklof discloses an audible cardiac monitor where “the pitch of the audio signal is proportional to blood pressure deviation from the normal and any rhythmic variation in pitch is proportional to heart beat rate.” (At least Abstract and Col 3, lines 11-61). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Venkatraman or Nakamura to generate audio of a heart sound, e.g. heartbeat, that has a pitch that is proportional to the difference between a rate of the pulse and a reference value, as taught by Eklof, as a known way to provide an audible indicator/alarm/monitor of patient’s cardiac condition.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Venkatraman or Nakamura as applied to claim 13 above, and further in view of US 2015/0190109 to Christensen et al.
Venkatraman and Nakamura are discussed above, but fail to explicitly teach a first/audio sensor that includes a housing and adhesive, as claimed. However, in the same field of endeavor, Christensen discloses a monitoring system from monitoring acoustic heart signals (Abstract; Fig. 4) that includes a housing (2 and/or 4) and adhesive patch (10) disposed on the housing configured to attach the sensor to the skin on a chest of the subject (Fig. 1 and Par 0027). Therefore, it would have been obvious to one of ordinary skill in the art to modify the first/audio sensor taught by Venkatraman or Nakamura to include a housing and adhesive, as taught by Christensen, as a known configuration/arrangement for similar audio/acoustic sensors that are used to monitor or obtain heart sounds, i.e. combining prior art elements according to known methods to yield predictable results. This could also be considered a simple substitution of one known audio/acoustic sensor for another in order to obtain the predictable results of monitoring heart sounds.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Venkatraman as applied to claim 18 above, and further in view of US 2010/0298899 to Donnelly et al.
Venkatraman is discussed above, including determining that the ECG is indicative of an arrhythmia (at least Pars 0047 and 0054-55), as well as providing additional inputs related to medical conditions of the patient (peripheral monitoring devices 175; Par 0038), and recommending a treatment (at least Par 0049), but fails to explicitly teach a treatment circuit that delivers an electric shock based on the detected ECG/arrhythmia and the additional inputs. However, in the same field, specifically health monitoring devices, Donnelly discloses a device that includes numerous sensors (110 and 135) including at least one sensor that detects an ECG of a patient and specifically determines that the ECG is indicative of an arrhythmia and uses the additional sensors or quality of life information as inputs to determine to output an electrical shock (Abstract and at least Pars 0007 and 0054-56). Therefore, it would have been obvious to one of ordinary skill to modify the monitoring device of Venkatraman to include the treatment device taught by Donnelly that uses multiple types of monitoring information, including an ECG indicative of arrythmia, to output an electrical shock to resuscitate a patient. Specifically, it’s a logical progression to include a treatment circuit/device to provide a life-saving electrical shock when warranted by the information provided by the monitoring sensors, including an ECG indicative of an arrhythmia and additional input/information related to the patient’s current medical/cardiac condition, as taught by Donnelly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2008/0273709 to Thiagarajan discloses a device that simultaneously outputs an ECG (via a display) and a heart sound (via a speaker); Fig. 10 and Par 0072.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796