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 .
Specification
The abstract of the disclosure is objected to because the sheet presenting the abstract includes other parts of the application. 37 C.F.R. 1.72 states that “(b) A brief abstract of the technical disclosure in the specification must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 38, 42, and 51 is/are objected to because of the following informalities:
In Claim 38 and 51, “said … HRV features satisfy” should read “said … HRV features scores satisfy”.
In Claim 42, line 5, “data.” should read “data;”. The claim has multiple periods (.), a claim can only have one period.
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.
Claim 38 and 51 recites the limitation “one or more heart rate variability (HRV) features scores” followed by “said one or more HRV features satisfy”. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “said… features” refers back to “features scores” or “feature value” or is something separate. The inconsistency creates ambiguity as to whether the steps operate on the scores or on the features themselves. Additionally, these claims recite “the respective HRV feature value” which lacks proper antecedent basis. The claims must clearly delineate whether “features scores” and “feature value” and “features” are different limitations.
Claim 50 and 57 is/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. The claims recite “identify an abnormality or a deviation of one or more physiological parameters”, and upon identification thereof, increase sampling rate. However, the claim does not define what constitutes “abnormality” or “deviation”, nor do they specify a baseline/threshold/magnitude by which a physiological parameter is determined to be abnormal. The terms “abnormality” and “deviation” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 38-41 and 50-52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160367157 A1 to Blake et al. (hereinafter “Blake”).
Regarding Claim 38 and 51, Blake discloses a system (see Abstract: “Methods, devices, and systems for monitoring heart rate variability (HRV)”) for identifying an allergic reaction of a subject (see Para 11: “some applications of HRV benefiting from real-time feedback include … food allergy alerting”, Para 07), comprising:
at least one sensor for sensing cardiovascular-related parameters of the subject and generate sensed data based thereon (see Para 59: “the device 101 … one strap electrode 307 and functions to extract the inter-beat intervals of the heart, and using these data to calculate heart rate variability”, Para 119: “optional onboard sensor(s), comprised of, but not limited to, an accelerometer, a gyroscopic sensor, a GPS, an EEG, or an electrodermal activity monitor”, and Para 09, 14-16, 128);
at least one processing circuitry (see Para 59: “a self-contained processing circuit 110”) configured to:
receiving said sensed data and calculating one or more heart rate variability (HRV) features scores, each feature score is indicative of the respective HRV feature value (see Para 21: “generating an HRV measurement based on the temporal RR interval array”, Para 107-111: “selected HRV measurement(s) are calculated using the principles outlined in: Heart rate variability—Standards of measurement … calculation of HRV measurement(s) may occur every time a new valid beat is detected”, Para 59-60, Fig.2-20 (HRV measurements, Value/threshold/Parameter));
determining whether said one or more HRV features satisfy a condition of allergic reaction (see Para 16: “generating an HRV measurement based on the temporal RR interval array; and comparing the generated HRV measurement to an HRV threshold and outputting a real-time notification when the HRV threshold is reached”, Para 113-114, Fig.2, 18 (Food allergies);
wherein if said one or more HRV features satisfy said condition, the processing circuitry is configured for generating instructions for outputting an alert (see Para 16: “outputting a real-time notification when the HRV threshold is reached”).
Regarding Claim 39, Blake further discloses the system, wherein said at least one sensor comprises photoplethysmography (PPG) sensor, electrocardiogram (ECG) sensor or both (see Para 14: “the systems … present invention utilizes EKG and/or, e.g., PPG to determined HRV to monitor”, Para 62: “an ECG analog front end circuit 306 coupled between the microprocessor 301 and the at least one strap electrode 307”, and Para 90).
Regarding Claim 40, Blake further discloses the system, wherein said one or more heart rate variability (HRV) features scores comprise at least one of: cardiac sympathetic index (Csi), modified Csi, standard deviation of the NN intervals (SDNN), root mean square of successive differences (RMSSD), mean heart rate, cardiovagal index (CVi), mean R-R, NN50, PNN50, or any combination thereof (see Fig. 2 (SDNN, RMSSD), Fig.13-14, 16, Para 25 (RR interval)).
Regarding Claim 41 and 52, Blake further discloses the system, wherein said at least one sensor comprises physiological parameters sensors that comprises at least one of: ECG sensor, temperature sensor for measuring skin temperature of the subject, accelerometer, blood pressure sensor, blood histamine level sensor, glucose sensor, SPO2 sensor, respiration rate sensor, or any combination thereof (see Para 128: “the device incorporates additional on-board sensor 1906 … configured to receive input from external sensors 1903, such as a GPS sensor, a respiration sensor, a SpO.sub.2 sensor, etc. The on-board sensor 1906 or the external sensors 1903 may be a sensor for acceleration, gyroscopic detection, temperature sensing, barometric pressure measurement and/or electrodermal activity identification”, and Para 20, 119, 121), wherein said sensed data comprises physiological sensed data that is generated based on measurements from the physiological parameters sensors (see Para 20 (a respiration rate, a blood pressure value, a body temperature), Para 119);
wherein said at least one processing circuitry is configured to process said physiological sensed data and to affect said HRV features scores based on said physiological sensed data (see Para 114: “the HRV threshold 1702 … determined based on heartrate, activity, motion, and/or temperature”, and Para 119, 149).
Regarding Claim 50, Blake further discloses the system, wherein said at least one sensor comprises physiological parameters sensors that comprises at least one of: ECG sensor, temperature sensor for measuring skin temperature of the subject, accelerometer, blood pressure sensor, blood histamine level sensor, glucose sensor, SPO2 sensor, respiration rate sensor, or any combination thereof, wherein said sensed data comprises physiological sensed data that is generated based on measurements from the physiological parameters sensors (see Para 128: “the device incorporates additional on-board sensor 1906 … configured to receive input from external sensors 1903, such as a GPS sensor, a respiration sensor, a SpO.sub.2 sensor, etc. The on-board sensor 1906 or the external sensors 1903 may be a sensor for acceleration, gyroscopic detection, temperature sensing, barometric pressure measurement and/or electrodermal activity identification”, and Para 20, 119, 121);
wherein the processing circuitry is configured to analyze said physiological sensed data to identify an abnormality or a deviation of one or more physiological parameters that are comprised in the physiological sensed data (see Para 12, 16, 20, 23, 55, 75, 121 (analyze the data and generate a real-time notification));
wherein upon identification of abnormality or a deviation of said one or more physiological parameters, the processing circuitry is configured to generate instructions to increase sampling rate of the at least one sensor for a selected time period (see Para 110-111: “it may be advantageous to utilize multiple sampling approaches for HRV determination, using a smaller array size for rapid assessment and a larger array size for more accurate determinations. Such a sampling approach may be fixed, programmatically changed, or even dynamically adjusted to accommodate specific application requirements …”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 42-48 and 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over Blake as applied to claim 38 and 51 above, further in view of “Real-time early detection of allergic reactions based on heart rate variability” to Gutiérrez-Rivas. (hereinafter “Gutiérrez-Rivas”) (NPL document attached).
Regarding Claim 42 and 53, Blake further discloses the system, wherein said at least one processing circuitry is further configured for setting said condition of allergic reaction (see Para 113-114: “HRV threshold value 1702 … pre-stored values, from derived values (e.g., from a combination of stored parameters and a defined algorithm) … threshold values calculated real time”, and Fig.18 ( Food allergies: Patient history and testing));
wherein said at least one processing circuitry is configured to receive population data indicative of population condition of allergic reaction (see Fig.18 (Food allergies: Patient history and testing)).
Blake discloses that threshold may come from “pre-stored” values and have patient history and testing results of food allergies, but does not explicitly disclose the pre-stored values are based on population data.
Another reference, Gutiérrez-Rivas, discloses a similar study/system of early detection of allergic reaction (see Chapter 1. Introduction), wherein setting the condition of allergic reaction from population data correlated to the subject (see Chapter 4.3: “… The value of Th depends on the maximum MeanPeak of each subject … the minimum MaxMeanPeak of the allergic group …”, and Chapter 4.4: Results).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Blake which already teaches that HRV threshold can be obtained from pre-stored values or from combination of stored parameters and a defined algorithm to be combined with the explicitly defined teaching of Gutiérrez-Rivas to have specific population based threshold to a known system to yield the predictable results of a clinically accurate/calibrated allergy alert threshold.
Regarding Claim 43-44, and 54, Blake further discloses the system, wherein said processing circuitry is configured to generate a personalized HRV behavior data indicative of the HRV behavior profile of the subject over time(see Para 142-143: “personalized version of the application would have the user select the condition they wish to monitor, then put the user through a series of tests relevant to their condition, from which the PPD can ‘learn’ their HRV and other parameters and then determine thresholds specific to the user”), wherein said setting is performed based on said personalized HRV behavior data and said population data (see Para 114: “… HRV threshold(s) determined based on heartrate, activity, motion, and/or temperature”);
wherein said setting comprises applying varying weight factors on the population data (see Para 13 and 70, 76, 114) and the personalized HRV behavior data (see Para 114: “the HRV threshold 1702 can be obtained from pre-stored values, from derived values (e.g., from a combination of stored parameters and a defined algorithm) or ideally (for certain applications) from dynamically determined parameters, with threshold values calculated real time”);
wherein the processing circuitry is configured to define HRV baseline based on said personalized HRV behavior data, wherein the processing circuitry is configured to identify in said personalized HRV behavior data a long term deviation of HRV baseline, wherein upon identification of said long term deviation of HRV baseline, the processing circuitry is further configured to perform at least one of: (i) generating instructions for outputting a high risk alert for an allergic reaction, (ii) setting said condition of allergic reaction to be more sensitive for alerts for a selected period of time or until no long term deviation is identified, or (iii) a combination of (i) and (ii) (see Para 117-119: “it can be advantageous to create and analyze a comparison of baseline versus short term HRV as part of this invention. It further can be an advantageous to create and analyze changes in HRV (e.g., rate of change) in short term versus long-term conditions”, Para 121).
Regarding Claim 45, Blake further discloses the system, comprising an accelerometer for generating acceleration data indicative of the movement of the subject, wherein the personalized HRV behavior data is generated also based on the acceleration data (see Para 119: “the notification may be automatically modified by inputs from optional onboard sensor(s) … an accelerometer”, Para 128: “the microprocessor 1910 receives at least one additional input (from the on-board sensor 1906 and/or the external sensors 1903) … additional input may be related to acceleration, rotation, orientation”, Para 149);
wherein said personalized HRV behavior data comprises historical sensed data of the subject (see Fig. 18 (Food allergies: Patient history and testing Parameters)).
Regarding Claim 46-48, and 55-56, Blake further discloses the system, where series of tests are conducted to determine validity of the heartbeat (see Para 102-103, 112, 117).
However, Blake fails to explicitly disclose a score threshold of at least modified Csi feature, mean R-R feature and CVi feature or a combination thereof or weighted calculations.
Gutiérrez-Rivas, discloses a similar study/system of early detection of allergic reaction (see Chapter 1. Introduction), wherein said condition of allergic reaction comprises a score threshold of at least modified Csi feature (see Chapter 2.4: Previous work “Cardiac sympathetic index (CSI) is obtained as SD1/SD2 … Cardiac vagal index (CVI) as SD1*SD2”);
wherein said condition of allergic reaction comprises a score threshold of at least one of :mean R-R feature and CVi feature or a combination thereof (see Chapter 4: Automated Allergy Detection “4.2 HRV feature selection: list of the studied features …”);
wherein said condition of allergic reaction comprises a score threshold of weighted calculations of two or more of: modified Csi feature, mean R-R feature and CVi feature (see Chapter 4: Automated Allergy Detection “4.2 HRV feature selection: … the resulting AUC of each parameter and Table 4.2-4 lists their values”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Blake which already teaches the HRV parameters/threshold (Fig.2 SD1/SD2) and R-R feature to be combined with the explicitly defined teaching of Gutiérrez-Rivas to have subjects Csi feature, CVi feature, mean R-R feature for a threshold based diagnostic system to obtain predictable results (see MPEP 2143).
Claim(s) 49 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Blake as applied to claim 38 and 51 above, further in view of US 20210350920 A1 to Vleugels et al. (hereinafter “Vleugels”).
Regarding Claim 49 and 57, Blake further discloses the system, comprising a limb accelerometer for generating limb acceleration data indicative of the movement of a limb of the subject, wherein the processing circuitry is configured to identify signature pattern in the limb acceleration data indicative of a predefined motion or action of the subject, and upon identifying the signature pattern, generating instructions to increase sampling rate of the at least one sensor for a selected time period (see Para 119: “an accelerometer”, Para 128: “sensor for acceleration”, Para 20, 56, 114, 121, 149-150 (disclose motion detection to monitor user activity), Para 110, 117 (advantage of increased sample size));
wherein said at least one sensor comprises physiological parameters sensors that comprises at least one of: ECG sensor, temperature sensor for measuring skin temperature of the subject, accelerometer, blood pressure sensor, blood histamine level sensor, glucose sensor, SPO2 sensor, respiration rate sensor, or any combination thereof, wherein said sensed data comprises physiological sensed data that is generated based on measurements from the physiological parameters sensors (see Para 128: “the device incorporates additional on-board sensor 1906 … configured to receive input from external sensors 1903, such as a GPS sensor, a respiration sensor, a SpO.sub.2 sensor, etc. The on-board sensor 1906 or the external sensors 1903 may be a sensor for acceleration, gyroscopic detection, temperature sensing, barometric pressure measurement and/or electrodermal activity identification”, and Para 20, 119, 121);
wherein the processing circuitry is configured to analyze said physiological sensed data to identify an abnormality or a deviation of one or more physiological parameters that are comprised in the physiological sensed data (see Para 12, 16, 20, 23, 55, 75, 121 (analyze the data and generate a real-time notification));
wherein upon identification of abnormality or a deviation of said one or more physiological parameters, the processing circuitry is configured to generate instructions to increase sampling rate of the at least one sensor for a selected time period (see Para 110-111: “it may be advantageous to utilize multiple sampling approaches for HRV determination, using a smaller array size for rapid assessment and a larger array size for more accurate determinations. Such a sampling approach may be fixed, programmatically changed, or even dynamically adjusted to accommodate specific application requirements …”).
However, fails to explicitly disclose accelerometer for generating limb acceleration, and identifying signature pattern indicative of eating activity of the subject.
Another reference, Vleugels, disclose a sensing device monitors and tracks food intake events and details (see Abstract), where the system comprise a limb accelerometer for generating limb acceleration data indicative of the movement of a limb of the subject (see Para 49-50: “Sensors may include … accelerometers … monitoring of movement or position of the body or of specific parts of the body,”, Para 75-76), wherein the processing circuitry is configured to identify signature pattern in the limb acceleration data indicative of a predefined motion or action of the subject (see Para 51-52: “food intake detection system 101 may monitor the outputs of accelerometer … determined by a gesture processor … gesture processor might be part of the processor of the worn device”), and upon identifying the signature pattern, generating instructions to increase sampling rate of the at least one sensor for a selected time period (see Para 95-96: “when a start of a behavior event has been determined, the processor may increase the sampling rate of the accelerometer …”);
wherein said signature pattern is indicative of eating activity of the subject (see Para 11: “sensing device monitors and tracks food intake events and details”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Blake which already teaches the HRV parameters and accelerometer sensor(s) for motion detection to be combined with the explicitly defined teaching of Vleugels to obtain more HRV data during the potentially relevant period to improve detection/notification of an allergic reaction .
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180296105 - Art relevant as a whole (see abstract).
US 20180028106 - Art relevant as a whole (see abstract).
US 10998101 – See Abstract.
US 20210401314 A1 - Art relevant as a whole (see abstract).
US 20210275034 A1 - Art relevant as a whole (see abstract, Fig. 51-55).
WO 2022103410 A1 - See abstract, Para 01.
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/I.J./ Examiner, Art Unit 3792
/JOHN R DOWNEY/ Primary Examiner, Art Unit 3792
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