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 .
Claim Objections
Claim 6 is objected to because of the following informalities:
In claim 6, in line 4, --- in --- should be inserted before “response”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rantanen (US Pub No. 2024/0041340) in view of Amano et al. (US Patent No. 6,095,984) and Galen et al. (US Pub No. 2012/0310100).
With regards to claim 1, Rantanen discloses an artificial intelligent finger-ring device (104; paragraph [0104], referring to the ring 104; Figures 1, 2) for pre-alarming heart disease, comprising:
a detection block (235) including a light receiver (“optical receivers”) and a light source (i.e. green LED/”optical transmitters”) emitting a green light, wherein a finger of a user reflects the green light to generate a response light signal, and the light receiver receives the response light signal (paragraphs [0029]-[0030], [0045], [0070]-[0073], referring to the PPG System (235) which includes optical transmitters (which may include LEDs) and optical receivers, wherein the rings may utilize green LEDs; Figures 1-2);
a communication-transmission block (220-a), comprising a near-distance or wireless communication circuit for transmitting the response light signal to an external device and receiving an analysis result from the external device (106), wherein the external device analyzes the response light signal to generate the analysis result, the analysis result includes a time-domain index relevant to monitoring heart disease (paragraphs [0045], [0058], referring to the communication module (220-a) which includes circuits that provide wireless and/or wired communication with the user device (106; “external device”), wherein the data transmitted from the ring to the user device (106) can include PPG data (i.e. “response light signal”), etc.; paragraphs [0086]-[0087], referring to the ring (104) being configured to collect and store data, wherein any of the data may be transferred to the user device (106) for processing, wherein the data processing operations may be performed by the ring (104), the user device (106), or any combination thereof; paragraphs [0094]-[0109], referring to determining a cardiovascular heath metric from the analysis of the PPG signal, wherein, a timing diagram that illustrates a relationship between a pulse waveform and time can be used to determine the cardiovascular health metric (i.e. time-domain index); paragraph [0133], referring to the PPG signal being input into a machine learning classifier to determine the cardiovascular health metric; paragraph [0070], referring to the user’s heart rate, HRV and other circulatory parameters being determined based on the user’s pulse waveform which is determined based on the PPG signal; Figures 1-4);
a control block (230-a) comprising a processor for being electrically connected with the detection block (235) and the communication-transmission block (220-a), receiving the analysis result, and determining whether to generate a warning (e.g. “alert”) or not according to the time-domain index (paragraphs [0018], [0040], referring to generating alerts, messages, or recommendations for the users “via the ring” (104) based on the determined cardiovascular health metric [which, as noted above, corresponds to a “time-domain index”]; paragraphs [0056]-[0057], referring to the processing module (230-a) of the ring (104) which may include one or more processors, microcontrollers, etc., and may communicate with the modules included in the ring, such as transmitting/receiving data to/from the modules and other components of the ring (104); paragraphs [0055], [0058], referring to the processing module/processor (230-a) of the ring being configured to receive data from the user device (106), wherein the processing module (230-a) of the ring may be configured to receive data from the user device (106) via the communication module (220a); Figures 1-4); and
a power block (210, 225) comprising a recharger (i.e. battery) and an electricity storage (i.e. capacitor) for suppyling electric power to the detection block (235), the communication-transmission block (220-a), and the control block (230-a) (paragraphs [0045], [0059]-[0060], referring to the battery (210) and/or capacitor, and power module (225); Figure 2).
Howerver, Rantanen does not specifically disclose that the analysis result includes a frequency-domain index, wherein the determination to generate the warning or not is further according to the frequency-domain index.
Further, though Rantanen does disclose that the heart disease may include heart arrhythmias (paragraph [0012]), Rantanen do not specifically disclose that the analysis result [which includes the time-domain index and the frequency domain index] is relevant to monitoring “occurrence of atrial fibrillation to the user”.
Amano et al. disclose an arrhythmia detecting apparatus wherein light emitting and light receiving elements are incorporated into a sensor unit (554) which is fixed to the finger using a ring-shaped sensor fixing band (52), wherein light having a wavelength of 300-700 nm [which includes green light] is irradiated on the detection site on the body and the received light signal is detected as a pulse waveform (Abstract; column 2, lines 19-40, column 3, lines 58-66; column 45, line 62-column 46, line 12; Figures 3, 38A,B). The arrhythmia detection means has a decision element which determines that arrhythmia has occurred when there is an interruption in the continuity of this change (Abstract; column 2, line 49-column 3, line 34). Methods employed for investigating the continuity of change in the pulse waveform include a time domain method employing pulse wave interval values, and a frequency domain method in which frequency analysis (FFT or wavelet transformation) is carried out on the pulse waveform, with continuity studied based on the results of this analysis (Abstract; column 2, line 49-column 3, line 34). When a decision is made that arrythmia has occurred, the user may be notified of this fact, and the time of the event recorded (column 3, lines 35-37). As depicted in Figure 20, a fourth notifying means (f15) can provide notice when the arrhythmia frequency information [i.e. frequency-domain index] exceeds a predetermined specified value and the arrhythmia sum information [which is a result of adding the number of times that deciding means (f8) determines arrythmia, and thus can be considered as associated with a “time-domain index relevant to monitoring heart diseases”] exceeds a predetermined specified value, thus even more accurately informing the user or monitor when the user’s condition has entered a dangerous state (column 29, lines 15-55; Figure 20).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the analysis result of Rantanen include a frequency-domain index, wherein the determination to generate the warning or not is further according to the frequency-domain index and further modify the analysis result to be relevant to monitoring occurrence of arrythmia to the user, as taught by Amano et al., in order to even more accurately inform the user when the user’s condition has entered a dangerous state (column 29, lines 53-56).
However, though atrial fibrillation is a type of arrythmia, the above combined references do not specifically disclose that monitored arrythmia is specifically atrial fibrillation.
Galen et al. disclose systems and methods for detecting and monitoring arrhythmias, such as atrial fibrillation, from a PPG signal, thereby identifying potential serious cardiovascular problems, identifying a changes in the severity of existing problems and keeping arrhythmias, such as atrial fibrillation, from interfering with physiological measurements (Abstract; paragraphs [0002]-[0003], paragraphs [0075]-[0076]). PPG signal 914 is acquired from a patient exhibiting atrial fibrillation (paragraphs [0092]-[0093]; Figure 9). Atrial fibrillation is characterized by erratic heart QRS intervals and manifests itself in PPG signal 914 (i.e. depicted in Figure 9 in an amplitude-time plot 912) as erratically varying amplitudes and periods of the pulses (paragraphs [0092]-[0093], Figure 9, note that erratically varying amplitudes and periods observed in the PPG signal is in the time-domain, and thus corresponds to a time-domain index). Atrial fibrillation can be detected in scalogram 924 by the absence of a pulse band and the absence of a pattern of local minimum and maximum points at scales (i.e., frequencies) above an expected pulse band based on historical heartbeat or pulse rhythm data for a certain patient or patient type (paragraph [0093], note that the absence of a pulse band and absence of the min/max points are at scales/frequencies, and thus corresponds to a “frequency-domain” index; Figure 9). The signal processing system may use various metrics to detect atrial fibrillation from PPG signal 914, scalogram 924, or both (paragraph [0093]; Figure 9). In some embodiments, the signal processing system may characterize the amplitude, timing, period, morphology, or any combination thereof of a pulse, pulses, or absence thereof of PPG signal 914, scalogram 924, or both (paragraphs [0092]-[0095]; Figure 9).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the monitored arrythmia of the above combined references be specifically atrial fibrillation, as taught by Galen et al., in order to identify potential serious cardiovascular problems, identify changes in the severity of existing problems and keep arrhythmias, such as atrial fibrillation, from interfering with physiological measurements (Abstract; paragraphs [0002]-[0003],
With regards to claim 2, Rantanen discloses that the device further comprises a sensing block which is electrically connected with the control block (230-a), the sensing block comprises at least one of an accelerometer, an electric-magnetic sensing device, and a microelectromechanical element (i.e. motion sensors (245), such as accelerometers, gyroscopes) for sensing a state (i.e. motion state) of the finger of the user, and transmitting the sensed state of the finger of the user to the control block (paragraphs [0078]-[0079], referring to the motion sensors (245), wherein the processing module (230-a) samples the motion signals at a sampling rate and determines motion of the ring (104) based on the sampled motion signals; Figure 2), wherein according to the sensed state, the control block controls the detection block to perform detection in real time or further comprises controlling the communication-transmission block to transmit the response light signal to the external device (paragraphs [0075], [0085], referring to the physiological measurements [which include the PPG measurements] being taken in response to determining that the user is in a specific state, such as an active state, resting state, and/or a sleeping state, wherein, for example, the ring can make the physiological measurements in a resting/sleep state in order to acquire cleaner physiological signals; note that this corresponds to controlling the detection bock (i.e. PPG System (235)) to perform detection in real time during a resting/sleep state; Figure 2).
With regards to claim 3, Rantanen discloses that the device further comprises a storage block (215) which is electrically connected with the control block (230-a) and storing the response light signal (paragraphs [0045], referring to the memory (215) which stores any of the data, including PPG data (i.e. response light signal) collected by the PPG system (235); Figure 2).
With regards to claim 4, Rantanen discloses that the device further comprises an alert block, comprising at least one of a vibrator, sound-maker, and a display screen for being electrically connected with the control block and controlled by the control block to make a visible or audible signal as the warning (paragraphs [0018]-[0019], [0040], [0130]-[0131], referring to a visible alert, such as a graphical representation and/or a message displayed on the GUI (500); Figure 5).
With regards to claim 5, Rantanen discloses that the light source of the detection block further comprises emitting a red light (i.e. red LED) or a light with different wavelengths, and the finger of the user reflects the red light or the light with different wavelengths to generate the response light signal (paragraphs [0029]-[0030], [0071], referring to the use of both green and red LEDs).
With regards to claim 6, Rantanen discloses that the control block (230-a) is electrically connected with the detection block (235) and controls the detection block to emit the green light and receive response the light signal in real time or according to a frequency (paragraph [0029], referring to the green LEDs; paragraphs [0074]-[0075], referring to the processing module (230-a) controlling one or both of the optical transmitters to transmit light while sampling the PPG signal generated by the optical receiver, wherein, for example, the transmitter may continuously emit light while the PPG signal is sampled at a sampling rate; paragraphs [0095]-[0096], referring to the ring continuously acquiring PPG signals (e.,g, at a sampling rate), and thus at real time and/or the processing module (230-a) sampling and/or receiving the user’s PPG signal continuously or at a sampling at a sufficient rate throughout the day and/or night (i.e. at a frequency); Figure 2).
With regards to claim 7, Rantanen discloses that the communication-transmission block includes a Bluetooth communication module, a near-field communication module, a wireless communication module, or a combination of at least two thereof (paragraphs [0057]-[0058], referring to the communication module (220-a) including wireless communication circuits, such as Bluetooth circuits and/or Wi-Fi circuits; Figure 2).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 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. Galen has been introduced to teach the analysis result including a time-domain index and a frequency-domain index relevant to monitoring “occurrence of atrial fibrillation” to the user.
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.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798