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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/25/2024 and 10/17/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “the period of time” in line 15 should be amended to read –the first period of time--. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: the phrase “the period of time” in line 9 should be amended to read –the first period of time--. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: the phrase “the period of time” in line 13 should be amended to read –the first period of time--. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 4, 5, 7, 8, 10, 11, 13-15, 17-19 and 21-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claims 1 and 26 recite a medical system, and claim 25 recites a series of steps or acts. Thus, the claims are directed to a product and a process. which are ones of the statutory categories of invention.
STEP 2A PRONG ONE: Claims 1, 25 and 26 recite(s) specific limitations/method steps of: cause the sensor apparatus to obtain, using the one or more cardiac sensors, cardiac data regarding the user during a first period of time, cause the sensor apparatus to obtain, using the one or more acceleration sensors, acceleration data regarding the user during the first period of time, determine, based on the cardiac data, first physiological data representing a cardiac activity of the user during the first period of time, determine, based on the acceleration data, second physiological data representing a variation of the acceleration data during the period of time, determine, based on the first physiological data and the second physiological data, a biomarker representing a health of the user, and store a data structure representing the biomarker. These limitations recite a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). For example, a caregiver can obtain the data from the sensors and determine a health biomarker/status of the patient. Thus, the claims are drawn to a Mental Process, which is an Abstract Idea. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
STEP 2A PRONG TWO: Claims 1, 25 and 26 does not recite additional elements that integrates the judicial exception into a practical application. Claims 1, 25 and 26 recites the following additional elements beyond the judicial exception: A) sensor apparatus, B) cardiac sensors, C) acceleration sensor, D) electronic device, and E) processor.
Accordingly, the combination of the additional element/step A-D does not integrate the exception into a practical application of the exception because the use of sensor apparatus, cardiac sensors, acceleration sensor, and electronic device is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)).
Element E does not integrate the exception into a practical application of the exception because the use of a controller/processor amounts to merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Accordingly, each of the additional elements or a combination of the additional elements do not integrate the abstract idea into a practical application as they fail to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: Claims 1, 25 and 26 does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, A) sensor apparatus, B) cardiac sensors, C) acceleration sensor, D) electronic device, and E) processor.
The combination of elements A-D of a sensor apparatus, cardiac sensors, acceleration sensor, and electronic device does not amount to significantly more than the judicial exception because the use of above elements is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)). Furthermore, the elements A-D are well-understood, routine, and conventional, as is evidenced by Nallathambi et al (US 2020/0077951), Chen et al (US 2024/0194338), and Chu et al (US 2016/0058314) which all show elements A-D as claimed in claims 1, 25 and 26 evidencing that these elements are well-understood, route, and conventional in the applanation arts.
Element E does not amount to significantly more than the judicial exception because adding a controller/processor is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g. a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine, and conventional activities previously known in the industry (see MPEP 2106.05(d)II).
Accordingly, the additional elements individual or in co do not integrate the abstract idea into a practical application as they fail to recite additional element(s) or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
When viewed alone or in combination, the limitations of claims 1, 2, 4, 5, 7, 8, 10, 11, 13-15, 17-19 and 21-26 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, claims 1, 2, 4, 5, 7, 8, 10, 11, 13-15, 17-19 and 21-26 are not patent eligible under 35 USC 101.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7, 8, 10, 17, 18, 19 and 21-26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chen et al (US 20240194338).
As to claims 1, 25 and 26, Chen teaches a medical monitoring system and method (system and method in fig.1-2, abstract) comprising:
a sensor apparatus (units 1 and 2 may be contact or worn by a user, par.24-26, fig.1) configured to be attached to a user's body, wherein the sensor apparatus comprises:
one or more cardiac sensors (heart rate detection unit 1, par.25, fig.1), and
one or more acceleration sensors (distance detection unit 2, having an accelerometer, par.26, fig.1);
an electronic device communicatively coupled to the sensor apparatus, wherein the electronic device comprises one or more computer processors and a memory (processor and memory in computing unit 3, par.9 and par.27, fig.1) that are configured to:
cause the sensor apparatus to obtain, using the one or more cardiac sensors, cardiac data regarding the user during a first period of time (collect a number of heartbeats and an amount of movement of a subject in a period of time in step S1, par.28, fig.2),
cause the sensor apparatus to obtain, using the one or more acceleration sensors, acceleration data regarding the user during the first period of time (collect a number of heartbeats and an amount of movement of a subject in a period of time in step S1, par.28, fig.2),
determine, based on the cardiac data, first physiological data representing a cardiac activity of the user during the first period of time (determine heart beats in steps S1 and S2, par.28, fig.2),
determine, based on the acceleration data, second physiological data representing a variation of the acceleration data during the period of time (determine user’s activity/movement in steps S1 and S2, par.28, fig.2),
determine, based on the first physiological data and the second physiological data, a biomarker representing a health of the user (determining healthy state and/or cardiac function of the subject from measured heart beats and movement of the subject, as in step S2, par.28-35, fig.2), and
store a data structure representing the biomarker (data storage in computing unit 3, stores required data, par.9).
As to claim 2, Chen teaches the medical monitoring system, wherein the biomarker represents at least one of a functional capacity of the user or a cardiopulmonary condition of the user (determining healthy state and/or cardiac function of the subject from measured heart beats and movement of the subject, as in step S2, par. 10 and par.28-35, fig.2).
As to claim 5, Chen teaches the medical monitoring system, wherein the first period of time is six minutes (the distance per beat may be tested based on clinical conditions of 6-minute walk test, par.29 and 31).
As to claim 7, Chen teaches the medical monitoring system, wherein the first physiological data represents a number of heartbeats of the user during the first period of time (collecting number of heartbeats, in S1, par.11 and par.29-31, fig.2).
As to claim 8, Chen teaches the medical monitoring system, wherein determining the first physiological data comprises: segmenting the cardiac data into a plurality of cardiac data segments, wherein each of the cardiac data segments represents a different respective heartbeat of the user (segmenting the cardiac data into plurality of segments/intervals, as best seen in table 1 and table2, par.31) , and determining, based on the cardiac data segments, the number of heartbeats of the user during the first period of time (determining level of heart state, par.31-32).
As to claim 10, Chen teaches the medical monitoring system, wherein the acceleration data comprises a plurality of acceleration signals, wherein each of the acceleration signals represents acceleration in a different respective spatial dimension (plurality of accelerations signals from continuously measuring acceleration, par.26, table 2 and table 3).
As to claim 17, Chen teaches the medical monitoring system, wherein determining the biomarker comprises determining a ratio of the first physiological data and the second physiological data (determining ratio of an average value of the distance per beat (CMPB) to an average value of the cardio force index with peak acceleration, par.44-45).
As to claim 18, Chen teaches the medical monitoring system, wherein causing the biomarker to be presented to the user comprises: determining a plurality of numerical ranges (determining number of heartbeats and an amount of movement of a subject in a period of time, par.28), wherein each of the numerical ranges corresponds to a different respective health rank (heart status based on number of heart beats, par.31-32 and par.34, table 2 and table 3), determining that the biomarker is within a first numerical range of the plurality of numerical ranges, wherein the first numerical range corresponds to a first health rank, and causing the first health rank to be presented to the user (heart status/heart failure class based on number of heart beats, par.31-32 and par.34, table 2 and table 3).
As to claim 19, Chen teaches the medical monitoring system, wherein causing the biomarker to be presented to the user comprises at least one of: presenting, using a display device, a graphical user interface to the user, wherein the graphical user interface comprises a graphical display element presenting the biomarker, or presenting, using an audio speaker, an audio notification to the user, wherein the audio notification indicates the biomarker (computing unit 3 may be coupled to a display device and a speaker, to present a current state of cardiac function of a subject to the subject or a monitor, par.37).
As to claim 21, Chen teaches the medical monitoring system, wherein the one or more computer processors are further configured to: determine, based on the biomarker, one or more recommendations for improving a health of the user, and cause the one or more recommendations to be presented to the user (when the heart of the subject is in a first warning state, the corresponding display device may display text representing “pay attention”, emit a yellow or orange light, display a yellow or orange pattern, and the like, and may be configured with a speaker to emit a sound representing “pay attention”. When the heart of the subject is in a second warning state, the corresponding display device may display text representing “please take a rest immediately”, par.37).
As to claim 22, Chen teaches the medical monitoring system, wherein the one or more computer processors are further configured to: instruct, using at least one of a display screen or an audio speaker, the user to walk during the first period of time (when the heart of the subject is in a healthy state, the corresponding display device may display text representing “healthy/normal”, emit a green light, display a green pattern,par.37)(Examiner respectfully notes that since red light means “please take a rest immediately”, so the green light inherently means instructing the user to keep walking).
As to claim 23, Chen teaches the medical monitoring system, wherein the one or more computer processors are further configured to: cause the sensor apparatus to obtain the cardiac data and the acceleration data continuously during a second period of time (data is measured continuously, end of tables 2 and 3), wherein the first period of time is a subset of the second period of time, and select the first period of time based on at least one of the cardiac data or the acceleration data (the Examiner respectfully notes the second period of time is the total period of time the user is being monitored, which can be for days, so the first period of time, which could be 6 mins walking is a subset of the second period of time, par.29, par.34 and first and second intervals in par.35).
As to claim 24, Chen teaches the medical monitoring system, wherein the one or more computer processors are further configured to: cause the biomarker to be presented to at least one of the user or an additional user (computing unit transmits data to other device, par.9, and computing unit 3 may send an instant message/signal to a preset monitoring unit, so as to care about the health condition of the subject in real time and avoid the danger of the subject, the monitoring unit is a clinic, a hospital, a police station, an ambulance station, or preset monitoring personnel who assist and care for the subjects, par.37).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being obvious over Chen et al (US 20240194338), in view of Nallathambi et al (US 2020/0077951).
As to claim 4, Chen teaches a cardiac sensor that can be attached to a user, but failed to explicitly teach the sensor apparatus is configured to be attached to the user's chest, and wherein the one or more cardiac sensors comprises an electrocardiogram (ECG) sensor.
However, Nallathambi teaches an analogous heart monitoring system (abstract, par.20, fig.1), wherein the sensor apparatus is configured to be attached to the user's chest (wearable sensor device 100 for measuring an electrocardiogram (ECG), phonocardiogram (PCG), and accelerometer (ACC) signals on a patient's skin surface, e.g., on the patient's chest, par.20), and wherein the one or more cardiac sensors comprises an electrocardiogram (ECG) sensor (wireless wearable sensor device 100 for measuring an electrocardiogram (ECG), par.20, fig.1).
Since ECG attached to patient’s chest is a well-known cardiac sensor, so it would have been obvious to one having an ordinary skill in the art before the effective filling date of the invention to substitute the cardiac sensor/unit taught by Chen’s invention with ECG sensor, as taught by Nallathambi’s invention, without changing its respective function, to determine heart disease, as taught by Nallathambi’s invention (par.28-30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 5712725596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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