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 .
Response to Arguments
Applicant’s arguments and amendments filed 09/19/2025 have been fully considered.
Regarding the Claim Objections, the amended claims have overcome the objection.
Regarding the 35 USC 112(a) Rejection, the applicant arguments provide additional details about the fourth, fifth, and sixth programs as discussed in the specification. The specification originally filled in 08/22/2022 does not provide the details discussed on the remarks on page 10, but is discussed under the amended specification filled on 09/19/2025. Arguments based on the amended specification cannot overcome the rejection because the added detail is unsupported by the original disclosure and thus constitutes new matter.
Regarding the 35 USC 112(b) Rejection, the applicant argues “claim 2 is not indefinite, as a PHOSITA would readily understand that the subprograms are compiled from source code written in a programming language to be executable by the microprocessor. The repetition does not introduce ambiguity as to the scope of the claim.”
Regarding Claims 2 through 5, the claim limitation of “one type of programming language” is indefinite because the claim limitation is unclear. The claim limitation of “one type of programming language” is unclear because the originally filed specification does not clarify whether the “one type of programming language” is the same for each subprogram or they are different; it is unclear what “type” means in the context of programming languages. Therefore, the originally filled specification doesn’t provide any clarity as to what type means or examples of these alleged types.
Though the applicant filled an amended specification which provides support for the applicant’s argument, but cannot be considered because the added detail is unsupported by the original disclosure and thus constitutes new matter. Therefore, the applicant’s arguments are not persuasive to overcome the rejection.
The applicant is directed to the 35 U.S.C 101 rejection below, necessitated by amendments where the abstract ideas and additional elements are defined through underlining abstract ideas and bolding additional elements.
Claim 1 (and its dependent claims) recite generating data, and providing signals which are groups as a mental process under abstract ideas. The additional elements include: sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, microprocessor, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery are not part of the abstract idea because those elements are generically recited within the claims. The abstract ideas within the 101 rejection fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind including observation, evaluation, judgement, and opinion. See MPEP 2106.04(a)(2), subsection III.
Regarding Claim 1, as shown in the 101 rejection below, recites: “a real-time monitoring device for human body, comprising:
a sensor module, comprising a first body and a first circuit assembly disposed in the first body, wherein the first circuit assembly comprises a first microphone, a temperature sensor and an inertial sensor; and
a processor module, comprising a second body and a second circuit assembly disposed in the second body, wherein the second circuit assembly comprises a second microphone, a microprocessor, a memory, and a wireless transmission interface;
wherein the first body is allowed to contact a human body by a body contacting surface thereof, and the memory storing an application program including instructions, such that in case the application program is executed, the microprocessor being configured for:
controlling the temperature sensor to measure a body temperature from the human body, thereby generating a body temperature sensing signal;
controlling the first microphone to collect a sound emitted from the human body, thereby generating a first sound signal;
controlling the inertial sensor to monitor a movement and/or a vibration of the human body, thereby generating a body activity sensing signal;
controlling the second microphone to collect said sound emitted from the human body, thereby generating a second sound signal;
judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal; and
analyzing the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal, so as to determine said physical condition includes at least one selected from a group consisting of excretion, abnormal heart rate (HR), abnormal respiration rate (RR), emission of abnormal bowel sounds, airway obstruction, going into a deep sleep, going into a light sleep, and going into a paradoxical sleep.”
Under MPEP 2106.05(a), it states in determining patent eligibility, examiners should consider whether the claim "purport(s) to improve the functioning of the computer itself" or "any other technology or technical field." Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). This consideration has also been referred to as the search for a technological solution to a technological problem. See e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016). It is further advised:
An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP §2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
Regarding the guidance from MPEP 2106.05(a), it is important to note, the judicial exception alone cannot provide the improvement. The claims are directed to generic analysis steps that are all within the capabilities of a human. The claimed invention is more analogous to Claim 1 of Example 46 provided by the USPTO October 2019 which was deemed ineligible under 101. Further from MPEP 2105.04(a)(2): “Examples of claims that recite mental processes include: a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);” This is clearly the same as the claimed invention. Nothing in the claim appears to reflect any improvement.
The evaluation of whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is ‘directed to’ the judicial exception is performed by identifying additional elements recited in the claim beyond the judicial exception and evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). The claim recites the additional elements of sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, microprocessor, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery. The claim recites that the microprocessor executes the limitations using the other additional elements listed.
Regarding the guidance from MPEP 2106.05(b), it’s important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. The amended claims contain the following additional elements: sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, microprocessor, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery, which are generic computer or generic computer components. The additional elements do not integrate the exception into a practical application or provide significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection.
Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. See CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's argument that the claimed method is tied to a particular machine because it ‘would not be necessary or possible without the Internet.’ . . . Regardless of whether "the Internet" can be viewed as a machine, it is clear that the Internet cannot perform the fraud detection steps of the claimed method"). For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly").
Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively.
Further, the limitations are executed on a microprocessor and utilize sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery are recited at a high level of generality. The sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery are used to perform an abstract idea, such that it amounts to no more than mere instructions to apply the exception using a generic computer or conventional equipment. The support structure merely indicate filed of use which does not provide significantly more. See MPEP 2106.05(f) and MPEP 2106.05(h). There is no indication that the claim as a whole includes an improvement to a computer or to a technological field, any alleged improvement is not reflected in the claims. See MPEP 2106.04(d)(1).
Therefore, the applicant’s arguments are not persuasive.
Regarding the 103 rejection, the applicant argues “the proposed combinations fail to account for the key inventive concepts of the claimed invention and rely on improper hindsight.” The applicant categorizes the arguments into two sections: A.) Rejection of Claim 1 over Chang in view of Lemelson, and B.) Rejection of Claims 2-9 over Chang, Lemelson, and Pinhas.
A.) Rejection of Claim 1 over Chang
The Applicant argues the combination of Chang’s device with Lemelson’s processing logic does not yield the claimed invention. Additionally, the applicant argues “the combination does not suggest the ability to analyze and distinguish the wide range of claimed conditions, from gastrointestinal events (excretion, bowel sounds) to respiratory events (airway obstruction). The ability of the claimed invention to reliably differentiate these disparate physiological events using a specific multi-modal algorithm constitutes an unexpected result not taught or suggested by the combination of a respiration monitor and a general signal analyzer.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., differentiate physiological events and multi-modal algorithm) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the applicant’s argument for “multi-modal algorithm constitutes an unexpected result,” the MPEP 2145 states, “a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected biological activity that were unsupported by comparative data held insufficient to overcome prima facie case of obviousness).” Therefore the applicant does not provide sufficient evidence, only a conclusory statement.
Chang teaches of the processor module (Chang | second compartment – element 406), but is silent in teaching a microprocessor; the memory storing an application program including instructions, such that in case the application program is executed, the microprocessor being configured for: judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal; and analyzing the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal, so as to determine said physical condition includes at least one selected from a group consisting of excretion, abnormal heart rate (HR), abnormal respiration rate (RR).
Lemelson teaches a microprocessor (microprocessor – element 11); the memory storing an application program including instructions (Column 2 lines 42-45, Predictive computer circuitry and programmed software is provided to automatically analyze. on a continuous basis, signals output by one or more transducers sensing body variables, such that in case the application program is executed, the microprocessor being configured for (Column 2 lines 59-61, microprocessor 11 having a RAM 12 and 60 ROM 13 to which are connected various sensors and computers as well as devices controlled thereby): judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal (Column 2 lines 61-67 to Column 3 lines 1-8, A body sound sensor 15…senses body sounds and outputs analog signals which are digitized in an analog-to-digital (ND) converter 16 wherein the resulting train(s) of digital signals are passed through the microprocessor 11 to a sound signal analyzing computer 33 which processes and compares such sound signals with recordings in its memory 34 to detect changes in body sounds, such as respiration sounds which are indicative of the onset and/or are predicative of the near future onset of a serious condition of the patient being monitored. Such computer analysis results in generation by computer 33 of code signals which are indicative of one or more body conditions, which signals are passed through computer 11 to a decision computer 43 connected also to computer 11); and analyzing the body temperature sensing signal (body temperature analyzing computer – element 41), the first sound signal (sound signal analyzing computer – element 33), the second sound signal (sound signal analyzing computer – element 33), and the body activity sensing signal (body vibrations analyzing computer – element 35), so as to determine said physical condition (decision computer – element 43; Column 4 lines 32-37, If the physical condition of the patient detected by the decision computer 43 as a result of comparing its computed 35 information with information in its memory 44 is determined by such computer to indicate or predict the onset of a serious physical condition. such as a heart attack, apnea or other condition requiring immediate medical treatment) includes at least one selected from a group consisting of excretion, abnormal heart rate (HR) (Column 4 lines 25-31, In the case of an EKG. coded signals are produced which represent not only the heart rate and rhythm ( as in the case of heart sounds described above) but also abnormalities in the waveform which are indicative of cardiac dysfunction such as myocardial ischemia or abnormalities in the ionic composition of the patient's blood), abnormal respiration rate (RR) (Column 4 lines 2-6, the system is able to detect abnormal breathing patterns such as apnea. tachypnea. hyperpnea ( e.g., Kussmaul breathing associated with metabolic acidosis), bradypnea, Cheyne-Stokes breathing. ataxic breathing. and obstructive breathing), emission of abnormal bowel sounds, airway obstruction, going into a deep sleep, going into a light sleep, and going into a paradoxical sleep [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Chang teaches the processing module and Lemelson teaches the microprocessor which the determines at least one of the listed physical conditions based on comparing the first sound signal to the second sound signal. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processing module within the monitoring device of Chang to incorporate the teachings of a microprocessor the microprocessor which the determines at least one of the listed physical conditions based on comparing the first sound signal to the second sound signal from Lemelson because doing so would allow for the computer to properly analyze the signals from the sensors, determine the physical condition, and provide the necessary medical treatment for the patient (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
B.) Rejection of Claims 2-9 over Chang, Lemelson, and Pinhas
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The claimed fifth and sixth subprograms perform a specific, unconventional task: synchronizing acoustic feature maps (Mel spectrograms) with motion-vector data on a frame-by-frame basis to perform event-specific, multi-modal correlation”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant references new subject matter in the amended specification, specifically within Paragraphs 0049-0059. This new content details the “event-specific, multimodal correlation” of synchronization signals. As the arguments rely on this new subject matter, they are unpersuasive and do not to overcome the rejection.
Conclusion
Therefore, the applicant’s argument regarding the modification of Chang in view of Lemelson for Claim 1 is not persuasive because Chang teaches the processing module and Lemelson teaches the microprocessor which the determines at least one of the listed physical conditions based on comparing the first sound signal to the second sound signal.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processing module within the monitoring device of Chang to incorporate the teachings of a microprocessor the microprocessor which the determines at least one of the listed physical conditions based on comparing the first sound signal to the second sound signal from Lemelson because doing so would allow for the computer to properly analyze the signals from the sensors, determine the physical condition, and provide the necessary medical treatment for the patient (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
Additionally, the applicant’s argument regarding the modification of Chang in view of Lemelson and Pinhas is not persuasive because the argument references “The claimed fifth and sixth subprograms perform a specific, unconventional task: synchronizing acoustic feature maps (Mel spectrograms) with motion-vector data on a frame-by-frame basis to perform event-specific, multi-modal correlation”) are not recited in the rejected claims. The Applicant references new subject matter in the amended specification, specifically within Paragraphs 0049-0059. This new content details the “event-specific, multimodal correlation” of synchronization signals. As the arguments rely on this new subject matter, they are unpersuasive and do not to overcome the rejection.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Response to Amendment
Specification
The amendment filed 09/19/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the newly amended paragraphs 0041-0065 on Pages 19-31.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1, the claim recites the function of “judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal,” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 1, the claim recites the function of “analyzing the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal, so as to determine said physical condition includes at least one selected from a group consisting of excretion, abnormal heart rate (HR), abnormal respiration rate (RR), emission of abnormal bowel sounds, airway obstruction, going into a deep sleep, going into a light sleep, and going into a paradoxical sleep,” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “analyzing” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claims 2, 4, and 5, the claim recites the function of “subprograms,” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “subprograms” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 2, the claim recites the function of a signal synchronizing process, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “signal synchronizing process” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 2, the claim recites the function “to judge whether the human body has at least one physical condition and then determine said physical condition,” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “to judge whether the human body has at least one physical condition and then determine said physical condition” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 3, the claim recites the function of “to calculate,” “to estimate,” and “by processing,” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “to calculate,” “to estimate,” and “by processing,” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Regarding Claim 4, the claim recites the function of “to judge whether there is a well contact between the first body and the human body by analyzing the body temperature sensing signal, the body activity sensing signal, a first frequency band and a second frequency band of the first sound signal,” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “to judge” and “analyzing” are treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
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 2-9 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.
In Claim 2, the claim limitation “one type of programming” renders the claim indefinite because the limitation is unclear. It is unclear because the limitation term is recited multiple times in the claim making it unclear if each recitation refers to the same element or not. For purposes of examination, the claim limitation is interpreted as the algorithm utilizes the same programming language throughout all of the subprograms.
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-20 recites at least one step or instruction for collecting and processing a signal, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, Claim 1 recites “a real-time monitoring device for human body, comprising:
a sensor module, comprising a first body and a first circuit assembly disposed in the first body, wherein the first circuit assembly comprises a first microphone, a temperature sensor and an inertial sensor; and
a processor module, comprising a second body and a second circuit assembly disposed in the second body, wherein the second circuit assembly comprises a second microphone, a microprocessor, a memory, and a wireless transmission interface;
wherein the first body is allowed to contact a human body by a body contacting surface thereof, and the memory storing an application program including instructions, such that in case the application program is executed, the microprocessor being configured for:
controlling the temperature sensor to measure a body temperature from the human body, thereby generating a body temperature sensing signal;
controlling the first microphone to collect a sound emitted from the human body, thereby generating a first sound signal;
controlling the inertial sensor to monitor a movement and/or a vibration of the human body, thereby generating a body activity sensing signal;
controlling the second microphone to collect said sound emitted from the human body, thereby generating a second sound signal;
judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal; and
analyzing the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal, so as to determine said physical condition includes at least one selected from a group consisting of excretion, abnormal heart rate (HR), abnormal respiration rate (RR), emission of abnormal bowel sounds, airway obstruction, going into a deep sleep, going into a light sleep, and going into a paradoxical sleep.”
A practitioner of the device can collect all the different signals the device requires. Then they analyze the signals to determine whether the patient has a physical condition.
Further, dependent Claims 2-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Specifically, dependent Claim 2 recites “The real-time monitoring device for human body of claim 1, wherein the application program consists of a plurality of subprograms, and the plurality of subprograms comprising:
a first subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to control the temperature sensor to measure the body temperature from the human body;
a second subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to control the first microphone and the second microphone to collect the sound emitted from the human body;
a third subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to control the inertial sensor to monitor the movement and/or the vibration of the human body;
a fourth subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to process the body temperature sensing signal, the first sound signal, the second sound signal, and/or the body activity sensing signal;
a fifth subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to apply a signal synchronizing process to the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal according to four timestamps that are respectively contained in the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal; and
a sixth, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to judge whether the human body has at least one physical condition and then determine said physical condition.”
Dependent Claim 3 recites, “The real-time monitoring device for human body of claim 2, wherein the plurality of subprograms further comprises:
a seventh subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to calculate an estimated body temperature according to the body temperature sensing signal, and to estimate at least one physiological parameter of the human body by processing the first sound signal, the second sound signal and the body activity sensing signal; wherein the physiological parameter is selected from a group consisting of heart rate (HR) and respiration rate (RR).”
Dependent Claim 4 recites, “The real-time monitoring device for human body of claim 3, wherein the plurality of subprograms further comprises:
an eighth subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to judge whether there is a well contact between the first body and the human body by analyzing the body temperature sensing signal, the body activity sensing signal, a first frequency band and a second frequency band of the first sound signal.”
Dependent Claim 5 recites, “The real-time monitoring device for human body of claim 4, wherein the plurality of subprograms further comprises:
a ninth subprogram, being compiled to be integrated in the application program by one type of programming language, and including instructions for configuring the microprocessor to generate a warning signal in case of there is existing said physical condition and/or at least one said physiological parameter exceeding a normal range, and then to transmit the warning signal to an electronic device through the wireless transmission interface.”
Dependent Claim 6 recites, “The real-time monitoring device for human body of claim 5, wherein the electronic device is selected from a group consisting of signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, and smart glasses.”
Dependent Claim 7, recites, “The real-time monitoring device for human body of claim 5, wherein the memory is selected from a group consisting of embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), and USB flash drive.”
Dependent Claim 8, recites, “The real-time monitoring device for human body of claim 5, wherein the microprocessor is provided with an analog-to-digital (A/D) convertor therein, and the A/D convertor directly digitizing the first sound signal, digitizing the second sound signal using a first sampling rate, and digitizing the body activity sensing signal using a second sampling rate.”
Dependent Claim 9, recites, “The real-time monitoring device for human body of claim 8, wherein the first sampling rate is not greater than 4 KHz, and the second sampling rate being not greater than 120 Hz.”
Dependent Claim 10, recites, “The real-time monitoring device for human body of claim 1, wherein the first body has a first accommodation space for receiving the first circuit assembly therein, and a first cover being connected to a first opening of the first accommodation space so as to shield the first circuit assembly.”
Dependent Claim 11, recites, “The real-time monitoring device for human body of claim 10, wherein an aperture being formed on a bottom of the first accommodation space, such that the first microphone is exposed out of the first body via the aperture.”
Dependent Claim 12, recites, “The real-time monitoring device for human body of claim 11, wherein a circular recess is formed on the body contacting surface of the first body, and the circular recess having a depth and a diameter in a range between 4.5 mm and 20 mm, such that a ratio of the diameter to the depth being not greater than 6.”
Dependent Claim 13, recites, “The real-time monitoring device for human body of claim 12, wherein a minimum value of the depth is 1.5 mm”
Dependent Claim 14, recites, “The real-time monitoring device for human body of claim 12, wherein the second body has a second accommodation space for receiving the second circuit assembly therein, and a second cover being connected to a second opening of the second accommodation space so as to shield the second circuit assembly”
Dependent Claim 15, recites, “The real-time monitoring device for human body of claim 12, wherein a body connecting member is connected between the first body and the second body, and the body connecting member being provided with an electrical connecting component therein, such that the first circuit assembly is coupled to the second circuit assembly through the electrical connecting component.”
Dependent Claim 16, recites, “The real-time monitoring device for human body of claim 15, further comprising: an article supporting unit, being disposed in the second accommodation space, and consisting of a platform and a plurality of supporting rods; wherein the platform is faced to a bottom of the second accommodation space, and the second circuit assembly being positioned in a space formed by the plurality of supporting rods and a bottom surface of the platform.”
Dependent Claim 17, recites, “The real-time monitoring device for human body of claim 16, wherein the processor module further comprises: a wireless charging module, being disposed on a top surface of the platform, and being coupled to the second circuit assembly; and a battery, being coupled to the second circuit assembly.”
Dependent Claim 18, recites, “The real-time monitoring device for human body of claim 15, wherein the second body, the body connecting member and the first body are allowed to be fixed on a mounting kit, such that after disposing the mounting kit on an article that is worn on the human body, the first body being set to contact the human body by the body contacting surface thereof.”
Dependent Claim 19, recites, “The real-time monitoring device for human body of claim 18, wherein in case of the first body being set to contact the human body, a device fixing member is allowed to be used in further fixing the second body on the article.”
Dependent Claim 20, recites, “The real-time monitoring device for human body of claim 15, wherein the second body and the first body are allowed to be connected with a device fixing member, such that the second body and the first body are allowed to be attached onto the human body through the device fixing member, thereby making the first body contact the human body by the body contacting surface thereof.”
Therefore, none of the Claims 1-20 amount to significantly more than the abstract idea itself. Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claim 1 (and their respective dependent Claims 2-20) is not integrated into a practical application under 2019 PEG because the additional elements either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, microprocessor, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery are generically recited computer elements in independent Claim 1 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processor module, microprocessor, memory, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, and wireless transmission interface as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, microprocessor, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, wireless charging module, and battery.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the sensor module collects signals directly from the body (Paragraph 0028, the sensor module 1S is set to contact the human body (e.g., a body 2 of a baby) by a body contacting surface); the processor module is used to estimate the physiological parameters of the baby (Paragraph 0005, the processor module also estimates physiological parameters of the baby); the first body is described functionally to have contact with the human body (Paragraph 0024, the first body are allowed to be attached onto the human body through the device fixing member, thereby making the first body 11 contact the human body by the body contacting surface thereof); the first microphone is described functionally to collect sound from the human body (Paragraph 0006, the first microphone to collect a sound emitted from the human body); the temperature sensor is described functionally to collect the temperature from the human body (Paragraph 0006, the temperature sensor to measure a body temperature from the human body); the inertial sensor is described functionally to monitor movement from the human body (Paragraph 0006, the inertial sensor to monitor a movement and/or a vibration of the human body); the second body is described functionally to hold the microprocessor, memory, microphone, and the wireless transmission interface (Paragraph 0006, the second body, wherein the second circuit assembly comprises a second microphone, a microprocessor, a memory, and a wireless transmission interface); the second microphone is described functionally to collect ambient sound and sound emitted from the human body (Paragraph 0006, the second microphone to collect said sound emitted from the human body and an ambient sound); the microprocessor is described functionally to control the temperature sensor, first and second microphone, inertial sensor and process the signals from the temperature sensor, first and second microphone, and inertial sensor (Paragraph 0007); the memory is described functionally to store the instructions of the program (Paragraph 0006, the memory storing an application program including instructions, such that in case the application program is executed) and can either be an embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive (Paragraph 0012); the electronic device can either be a signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, and smart glasses (Paragraph 0011); the analog-to-digital (A/D) convertor is described functionally to digitize the signals collected (Paragraph 0013); the following additional elements are components, when assembled together, form the monitoring device: first accommodation space, first cover, aperture, circular recess, second accommodation space, second cover, second opening, body connecting member, electrical connecting component, an article supporting unit, platform, supporting rods, platform, wireless charging module, battery, mounting kit, article, body contacting surface (Paragraph 0031-0034).
Accordingly, in light of Applicant’s specification, the claimed term sensor module, first body, first circuit assembly, processor module, second body, second circuit assembly, microprocessor, memory, and wireless transmission interface are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the sensor module, first body, first circuit assembly, first microphone, temperature sensor, inertial sensor, processor module, second body, second circuit assembly, second microphone, memory, wireless transmission interface, electronic device, signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer, all-in-one computer, smart phone, smart watch, smart glasses, embedded flash (eFlash) memory, flash memory chip, hard drive (HD), solid state drive (SSD), USB flash drive, analog-to-digital (A/D) convertor, first accommodation space, first cover, aperture, circular recess, second accommodation space, second cover, second opening, body connecting member, electrical connecting component, an article supporting unit, platform, supporting rods, platform, wireless charging module, battery, mounting kit, article, and body contacting surface. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the device of Claims 1-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101.
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 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.
Claims 1, 10, 11-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 20160324466 A1) in view of Lemelson (US 5738102 A).
Regarding Claim 1, Chang discloses a real-time monitoring device for human body (monitoring device – element 400), comprising:
a sensor module (first compartment – 404), comprising a first body (first compartment – 404; [Examiner’s note, element 204 and 404 are the first compartment.]) and a first circuit assembly (microcontroller (MCU) – element 210) disposed in the first body, wherein the first circuit assembly comprises a first microphone (respiration sensor – element 110; Paragraph 0028, The respiration sensor 110 may, in some embodiments, be a microphone that can monitor the breathing sounds of the infant as illustrated by block 120), a temperature sensor (temperature sensor – element 106) and an inertial sensor (sleep position sensor – element 102); and
a processor module (second compartment – element 406), comprising a second body (second compartment – element 406; [Examiner’s note, element 206 and 406 are the second compartment.]) and a second circuit assembly (microcontroller (MCU) – element 212) disposed in the second body, wherein the second circuit assembly comprises a second microphone (ambient noise sensor – element 112; Paragraph 0028, ambient noise sensor 112 may also be a microphone, this microphone, however, is used to monitor ambient noise as further illustrated by block 120. The ambient noise may be subtracted from the breathing sounds to derive acoustic signals corresponding to the true breathing sounds of the infant), a memory (Paragraph 0056, In addition to a memory component integrated within MCU 212, memory card 422 may be included in device 400. Memory card 422 may be any type of electronic flash memory data storage device used for storing digital information, e.g., information from sensors 102, 104, 106, 108, 110, and 112), and a wireless transmission interface (wireless transmission interface – element 440);
wherein the first body is allowed to connect a human body by a body contacting surface thereof (Paragraph 0049, First compartment 404 may be dimensioned such that it can be attached to a portion of the subject's skin at the suprasternal notch. In this aspect, first compartment 404 can be dimensioned to contain components of device 400 that should be positioned closest to the infant's face during monitoring).
Chang fails to expressly disclose, a microprocessor; the memory storing an application program including instructions, such that in case the application program is executed, the microprocessor being configured for: controlling the temperature sensor to measure a body temperature from the human body, thereby generating a body temperature sensing signal; controlling the first microphone to collect a sound emitted from the human body, thereby generating a first sound signal; controlling the inertial sensor to monitor a movement and/or a vibration of the human body, thereby generating a body activity sensing signal; controlling the second microphone to collect said sound emitted from the human body, thereby generating a second sound signal; judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal; and analyzing the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal, so as to determine said physical condition includes at least one selected from a group consisting of excretion, abnormal heart rate (HR), abnormal respiration rate (RR).
Lemelson teaches a microprocessor (microprocessor – element 11); the memory storing an application program including instructions (Column 2 lines 42-45, Predictive computer circuitry and programmed software is provided to automatically analyze. on a continuous basis, signals output by one or more transducers sensing body variables, such that in case the application program is executed, the microprocessor being configured for (Column 2 lines 59-61, microprocessor 11 having a RAM 12 and 60 ROM 13 to which are connected various sensors and computers as well as devices controlled thereby):
controlling the temperature sensor to measure a body temperature from the human body, thereby generating a body temperature sensing signal (Column 3 lines 41-51, A body temperature sensor 24 is in temperature sensing relationship with the body of the patient and generates output analog signals indicative of body temperature which signals are digitized in an AID converter 25 and passed through computer-microprocessor 11 to a body temperature analyzing computer 41 having a memory 42. which after analyzing same. generates code signals which it passes to computer 43 having a memory 42 through microprocessor 11);
controlling the first microphone to collect a sound emitted from the human body, thereby generating a first sound signal (Column 2 lines 61-67, A body sound sensor 15. located in the mattress. pad or near the patient, senses body sounds and outputs analog signals which are digitized in an analog-to-digital (ND) converter 16 wherein the resulting train(s) of digital signals are passed through the microprocessor 11 to a sound signal analyzing computer 33 which processes and compares such sound signals);
controlling the inertial sensor to monitor a movement and/or a vibration of the human body, thereby generating a body activity sensing signal (Column 3 lines 9-15, A body vibration sensor 18 which may comprise sensor 15 or be separate therefrom. is supported by the mattress or a pad disposed beneath the patient. senses body vibrations caused by body movements. heartbeat and respiration and generates output analog electrical signals which are digitized in an AID converted 19 and passed through microprocessor 11 to a body vibrations analyzing computer 35);
controlling the second microphone to collect said sound emitted from the human body, thereby generating a second sound signal (Column 2 lines 61-67, A body sound sensor 15. located in the mattress. pad or near the patient, senses body sounds and outputs analog signals which are digitized in an analog-to-digital (ND) converter 16 wherein the resulting train(s) of digital signals are passed through the microprocessor 11 to a sound signal analyzing computer 33 which processes and compares such sound signals);
judging whether the human body has at least one physical condition by comparing the first sound signal with the second sound signal (Column 2 lines 61-67 to Column 3 lines 1-8, A body sound sensor 15…senses body sounds and outputs analog signals which are digitized in an analog-to-digital (ND) converter 16 wherein the resulting train(s) of digital signals are passed through the microprocessor 11 to a sound signal analyzing computer 33 which processes and compares such sound signals with recordings in its memory 34 to detect changes in body sounds, such as respiration sounds which are indicative of the onset and/or are predicative of the near future onset of a serious condition of the patient being monitored. Such computer analysis results in generation by computer 33 of code signals which are indicative of one or more body conditions, which signals are passed through computer 11 to a decision computer 43 connected also to computer 11); and
analyzing the body temperature sensing signal (body temperature analyzing computer – element 41), the first sound signal (sound signal analyzing computer – element 33), the second sound signal (sound signal analyzing computer – element 33), and the body activity sensing signal (body vibrations analyzing computer – element 35), so as to determine said physical condition (decision computer – element 43; Column 4 lines 32-37, If the physical condition of the patient detected by the decision computer 43 as a result of comparing its computed 35 information with information in its memory 44 is determined by such computer to indicate or predict the onset of a serious physical condition. such as a heart attack, apnea or other condition requiring immediate medical treatment) includes at least one selected from a group consisting of excretion, abnormal heart rate (HR) (Column 4 lines 25-31, In the case of an EKG. coded signals are produced which represent not only the heart rate and rhythm ( as in the case of heart sounds described above) but also abnormalities in the waveform which are indicative of cardiac dysfunction such as myocardial ischemia or abnormalities in the ionic composition of the patient's blood), abnormal respiration rate (RR) (Column 4 lines 2-6, the system is able to detect abnormal breathing patterns such as apnea. tachypnea. hyperpnea ( e.g., Kussmaul breathing associated with metabolic acidosis), bradypnea, Cheyne-Stokes breathing. ataxic breathing. and obstructive breathing).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang to incorporate the teachings of a microprocessor and memory where it controls a sensor and generates a corresponding signal from Lemelson. Doing so would allow for the computer to properly analyze the signals from the sensors and provide necessary medical treatment for the patient (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
Regarding Claim 10, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 1, wherein the first body (Chang | first compartment – 404; [Examiner’s note, element 204 and 404 are the first compartment.]) has a first accommodation space for receiving the first circuit assembly therein (Chang | Figure 2A, 2B and 4A; [Examiner’s note, the Annotated Figure 1 highlights the first body where the first accommodation space for receiving the first circuit assembly]), and a first cover being connected to a first opening of the first accommodation space so as to shield the first circuit assembly (Chang |
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cover member – element 430).
Annotated Figure 1 | The figure identifies the first compartment, the first accommodation space, and the first circuit assembly. The first compartment contains a space, the first accommodation space, where the first circuit assembly (MCU) resides in. One having ordinary skill in the art can determine the components shown in Figures 2A-B are the same components within the same compartments in Figures 4A because Paragraph 0081 discloses In the preceding detailed description, specific embodiments are described. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the claims. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense.
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Regarding Claim 11, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 10, wherein an aperture being formed on a bottom of the first accommodation space, such that the first microphone is exposed out of the first body via the aperture (Chang | Figure 2B; Paragraph 0040, Respiration sensor 110 may also be positioned near opening 220 of first compartment 204 such that it is near the infant's body an can detect breathing sounds through opening 220).
Annotated Figure 2 | The figure illustrates the microphone (respiration sensor) is exposed out of the first body via the aperture.
Regarding Claim 12, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 11, wherein a circular recess (Chang | openings – element 220 and 222) is formed on the body contacting surface of the first body (Chang | Paragraph 40, These portions of compartments 204 and 206 may include openings 220 and 222, respectively, which allow the sensors to monitor the temperature of the subject or the environment directly. Openings 220, 222 may be covered by a protective material 224, 226, respectively, that protects the device while still allowing for heat transfer to the sensors (e.g. a metal). Respiration sensor 110 may also be positioned near opening 220 of first compartment 204 such that it is near the infant's body and can detect breathing sounds through opening 220; Figures 2A and 3A), and Chang is silent on the circular recess having a depth and a diameter in a range between 4.5 mm and 20 mm, such that a ratio of the diameter to the depth being not greater than 6. It would have been obvious to one of ordinary skill in the art to have modified Chang to have circular recess having a depth and a diameter in a range between 4.5 mm and 20 mm, such that a ratio of the diameter to the depth being not greater than 6 since it would be considered a design choice within the skill of one of ordinary skill in the art and because in Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04 IV. A.
Regarding Claim 13, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 12, wherein Chang is silent on a minimum value of the depth is 1.5 mm. It would have been obvious to one of ordinary skill in the art to have modified Chang to have a depth of at least 1.5 mm since it would be considered a design choice within the skill of one of ordinary skill in the art and because in Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04 IV. A.
Regarding Claim 14, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 12, wherein the second body (Chang | second compartment – element 406; [Examiner’s note, element 206 and 406 are the second compartment.) has a second accommodation space for receiving the second circuit assembly therein (Chang | Figure 2A, 2B and 4A; [Examiner’s note, the Annotated Figure 2 highlights the second body where the second accommodation space for receiving the second circuit assembly]), and a second cover being connected to a second opening of the second accommodation space so as to shield the second circuit assembly (Chang | cover member – element 432).
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Annotated Figure 3 | The figure identifies the second compartment, the second accommodation space, and the second circuit assembly. The second compartment contains a space, the second accommodation space, where the second circuit assembly (MCU) resides in. One having ordinary skill in the art can determine the components shown in Figures 2A-B are the same components within the same compartments in Figures 4A because Paragraph 0081 discloses In the preceding detailed description, specific embodiments are described. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the claims. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense.
Regarding Claim 15, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 12, wherein a body connecting member (connecting arm – element 408) is connected between the first body and the second body, and the body connecting member being provided with an electrical connecting component therein, such that the first circuit assembly is coupled to the second circuit assembly through the electrical connecting component (Paragraph 0051, first compartment 404 and second compartment 406 are separate compartments attached to one another by, for example, connecting arm 408. Connecting arm 408 provides sufficient space between the two compartments such that first compartment 404 can be positioned at the suprasternal notch while second compartment 406 is positioned over the subject's clothing. Connecting arm 408 8 is further dimensioned to provide a conduit for wires or other components extending between components within the first and second compartments 404, 406).
Regarding Claim 18, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 15, wherein the second body, the body connecting member and the first body are allowed to be fixed on a mounting kit, such that after disposing the mounting kit on an article that is worn on the human body, the first body being set to contact the human body by the body contacting surface thereof (Chang | Paragraph 0050, During operation, first compartment 404 can be attached to the skin at the suprasternal notch using, for example, a layer of hypoallergenic adhesive hydrogel. Second compartment 406 can be placed on the top of the subject's clothing and secured to the clothing by, for example, buttons, straps or a hook and loop fastener such as Velcro®).
Regarding Claim 19, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 18, wherein in case of the first body being set to contact the human body, a device fixing member is allowed to be used in further fixing the second body on the article (Chang | Paragraph 0050, During operation, first compartment 404 can be attached to the skin at the suprasternal notch using, for example, a layer of hypoallergenic adhesive hydrogel. Second compartment 406 can be placed on the top of the subject's clothing and secured to the clothing by, for example, buttons, straps or a hook and loop fastener such as Velcro®).
Regarding Claim 20, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 15, wherein the second body and the first body are allowed to be connected with a device fixing member (Chang | connecting arm – element 408), such that the second body and the first body are allowed to be attached onto the human body through the device fixing member, thereby making the first body contact the human body by the body contacting surface thereof (Chang | Paragraph 0051, first compartment 404 and second compartment 406 are separate compartments attached to one another by, for example, connecting arm 408. Connecting arm 408 provides sufficient space between the two compartments such that first compartment 404 can be positioned at the suprasternal notch while second compartment 406 is positioned over the subject's clothing).
Claims 2-9 are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Lemelson further in view of US Patent Application 20070118054 A1 to Pinhas et al. (herein Pinhas).
Regarding Claim 2, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 1, being compiled to be integrated in the application program by one type of programming language (Chang | Paragraph 0079, The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein or it may prove convenient to construct a more specialized device to perform the described method. In addition, the invention is not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein). By broadest reasonable interpretation, the programming language can be done using a singular or various programming languages.
While the primary reference of Chang fails to expressly disclose the microprocessor to control the various sensors and generate the corresponding signals, Lemelson teaches wherein the application program consists of a plurality of subprograms, and the plurality of subprograms (Lemelson | Column 2 lines 42-45, Predictive computer circuitry and programmed software is provided to automatically analyze. on a continuous basis, signals output by one or more transducers sensing body variables). By broadest reasonable interpretation, the application program consists of a numerous instructions regarding the generation of signals from their perspective sensors. One skilled in the art can determine the application program consists of a plurality of sub programs, comprising:
a first subprogram, and including instructions for configuring the microprocessor (microprocessor – element 11) to control (Lemelson | Column 2, lines 59-61, microprocessor 11 having a RAM 12 and 60 ROM 13 to which are connected various sensors and computers as well as devices controlled thereby) the temperature sensor to measure the body temperature from the human body (Lemelson | Column 3 lines 41-51);
a second subprogram, and including instructions for configuring the microprocessor (microprocessor – element 11) to control (Lemelson | Column 2, lines 59-61) the first microphone and the second microphone to collect the sound emitted from the human body (Lemelson | Column 2 lines 61-67);
a third subprogram, and including instructions for configuring the microprocessor (microprocessor – element 11) to control (Lemelson | Column 2, lines 59-61) the inertial sensor to monitor the movement and/or the vibration of the human body (Lemelson | Column 3, lines 9-15);
a fourth subprogram, and including instructions for configuring the microprocessor (microprocessor – element 11) to process the body temperature sensing signal (Lemelson | Column 3 lines 41-51), the first sound signal (Lemelson | Column 2 lines 61-67), the second sound signal (Lemelson | Column 2 lines 61-67), and/or the body activity sensing signal (Lemelson | Column 3, lines 9-15);
a fifth subprogram, including instructions for configuring the microprocessor (microprocessor – element 11); and
a sixth, and including instructions for configuring the microprocessor to judge whether the human body has at least one physical condition and then determine said physical condition (Lemelson | decision computer – element 43; Column 3 lines 4-8, 27-41, 46-50; Column 4 lines 32-36; [Examiner’s note, the decision computer receives the signals from the various sensors and determines whether a physical condition occurs and which physical condition the subject is experiencing).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang to incorporate the teachings of controlling the sensors and generating the corresponding signal to determine a physical condition from Lemelson. Doing so would allow for the necessary medical treatment the patient may need (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
Chang in view of Lemelson fails to expressly disclose the instructions for the fifth subprogram. Pinhas teaches, to apply a signal synchronizing process to the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal according to four timestamps that are respectively contained in the body temperature sensing signal, the first sound signal, the second sound signal, and the body activity sensing signal (Pinhas | Paragraph 0416, system 10 implements PCA analysis within pattern analysis module 16 to clinical parameter patterns recorded successively over many nights, in order to identify unique patterns signifying upcoming clinical episodes. Data are synchronized based on the time of recording during night sleep; [Examiner’s note, the pattern analysis module 16 incorporates the signals from the motion sensor, acoustic sensor, and temperature sensor, as shown in Figure 2.]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang in view of Lemelson to incorporate the teachings of a signal synchronizing process from Pinhas. Doing so would allow for monitoring the patient’s physiological conditions and the analyzed signals will provide critical information to the patient’s physician (Paragraph 0067, monitoring patients for the occurrence or recurrence of a physiological event, for example, a chronic illness or ailment, that can assist the patient or healthcare provider in treating the ailment or mitigating the effects of the ailment. By means of automated sensors and electronic signal processing, aspects of the invention detect vital, and not so vital, signs to detect and characterize the onset of a physiological event and, in some aspects, treat the event, for example, with therapy or medication).
Regarding Claim 3, Chang in view of Lemelson further in view of Pinhas teaches the real-time monitoring device for human body of claim 1, being compiled to be integrated in the application program by one type of programming language (Chang | Paragraph 0079, The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein or it may prove convenient to construct a more specialized device to perform the described method. In addition, the invention is not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein). By broadest reasonable interpretation, the programming language can be done using a singular or various programming languages.
While the primary reference of Chang fails to expressly disclose the microprocessor to calculate the body temperature and determine whether the subject is experiencing a physical condition, Lemelson teaches a seventh subprogram, and including instructions for configuring the microprocessor to calculate an estimated body temperature according to the body temperature sensing signal (Lemelson | Column 3 lines 42-50). By broadest reasonable interpretation, one skilled in the art would understand the body temperature signal must be the estimated body temperature for the decision computer (43) to provide an analysis of the signal and provide further steps once the subject experiencing a physical condition, and to estimate at least one physiological parameter of the human body by processing the first sound signal, the second sound signal and the body activity sensing signal (Lemelson | decision computer – element 43; Column 4 lines 32-36; [Examiner’s note, the decision computer receive all signals from the various analyzing computers (elements 33, 35, 37, 39, and 41) to determine whether the subject is experiencing a physiological parameter.]); wherein the physiological parameter is selected from a group consisting of heart rate (HR) and respiration rate (RR) (Lemelson | Abstract | Such physiological variables monitored by the system may include lung sounds. respiratory rate and rhythm. heart rate and rhythm, heart sounds, and body temperature. Coded signals relating to the physiological variables are produced and compared with reference versions of same by a decision computer in order to evaluate the patient's condition).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang to incorporate the teachings of calculating the subject’s body temperature and determining a physiological parameter occurs from Lemelson. Doing so would allow for the necessary medical treatment the patient may need (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
Regarding Claim 4, Chang in view of Lemelson further in view of Pinhas teaches the real-time monitoring device for human body of claim 3, wherein the plurality of subprograms further comprises:
an eighth subprogram, being compiled to be integrated in the application program by one type of programming language (Chang | Paragraph 0079, The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein or it may prove convenient to construct a more specialized device to perform the described method. In addition, the invention is not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein). By broadest reasonable interpretation, the programming language can be done using a singular or various programming languages, and including instructions for configuring the microprocessor to judge whether there is a well contact between the first body and the human body by analyzing the body temperature sensing signal, the body activity sensing signal, a first frequency band and a second frequency band of the first sound signal (Chang | Paragraph 0025, sensors including the temperature sensor and respiration sensor will be located in the undersurface of the device so that they have adequate skin contact in order to provide adequate sensing of the infant's skin temperature and airway sounds; Paragraph 0034, During operation, first compartment 204 can be attached to the skin at the suprasternal notch using, for example, a layer of hypoallergenic adhesive hydrogel. When the first compartment sensors have inadequate skin contact, such as device misplacement or movement artifacts, an indicator light will flash to alert the parents).
Regarding Claim 5, Chang in view of Lemelson further in view of Pinhas teaches the real-time monitoring device for human body of claim 4, wherein the plurality of subprograms further comprises:
a ninth subprogram, being compiled to be integrated in the application program by one type of programming language (Chang | Paragraph 0079, The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein or it may prove convenient to construct a more specialized device to perform the described method. In addition, the invention is not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein). By broadest reasonable interpretation, the programming language can be done using a singular or various programming languages, and including instructions for configuring the microprocessor to generate a warning signal in case of there is existing said physical condition and/or at least one said physiological parameter exceeding a normal range, and then to transmit the warning signal to an electronic device through the wireless transmission interface (Chang | Paragraph 0062, RMS 506 may be a database system that is hosted by a computer server. The purpose of RMS 506 is to receive data from the gateway over the Internet and log the data into databases for individual infants. In the case of a critical RSS—such as high CO.sub.2 or apnea, the RMS will generate alerts, such as instant messaging, text messages, phone calls with a synthesized message, or other pre-determined forms of notification, in addition to alarms by the gateway. Thus, the gateway 502 produces local alerts, whereas the RMS 506 both receives alerts from the gateway (and logs the events) and generates its own alerts. The RMS 506 can also provide a web interface to its users and service providers. This will give users with web browsers (including those on smart phones) instant access to current status from anywhere. Applications (apps) for smartphone users will be available for common operating systems (such as iOS, Android and Windows) to gain direct access to RMS 506 and follow the monitoring of an infant in real time).
Furthermore Lemelson also teaches including instructions for configuring the microprocessor to generate a warning signal in case of there is existing said physical condition and/or at least one said physiological parameter exceeding a normal range, and then to transmit the warning signal to an electronic device (Lemelson | Column 4 lines 32-59) through the wireless transmission interface (interface – element 47).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang to incorporate the teachings of a warning when a physical condition or physical parameter is met from Lemelson. Doing so would allow for a medical personnel to provide the necessary medical treatment for the patient (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
Regarding Claim 6, Chang in view of Lemelson further in view of Pinhas teaches the real-time monitoring device for human body of claim 5, wherein the electronic device (Chang | remote monitors – element 510) is selected from a group consisting of signal transceiver device, tablet computer, cloud server, laptop computer, desktop computer (Chang | Paragraph 0058, remote monitors 510, which may include a desktop computer, a portable computer or a web-enabled smart phone).
Regarding Claim 7, Chang in view of Lemelson further in view of Pinhas teaches the real-time monitoring device for human body of claim 5, wherein the memory is selected from a group consisting of flash memory chip (Chang | Paragraph 0056, Memory card 422 may be any type of electronic flash memory data storage device used for storing digital information).
Regarding Claim 8, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 5, wherein the microprocessor (Lemelson | microprocessor – element 11) is provided with an analog-to-digital (A/D) convertor (Lemelson | A/D – elements 16, 19, 22, and 25) therein, and the A/D convertor directly digitizing the first sound signal (Lemelson | Column 2 lines 61-67), digitizing the second sound signal using a first sampling rate (Lemelson | Column 2 lines 61-67). By broadest reasonable interpretation, the digitized body sound signals from the analog to digital converter is the first sampling rate, and digitizing the body activity sensing signal using a second sampling rate (Lemelson | Column 3 lines 9-14). By broadest reasonable interpretation, the digitized body activity sensing signals from the analog to digital converter is the second sampling rate.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang to incorporate the teachings of the analog-to-digital (A/D) convertor from Lemelson. Doing so would allow for the computer to properly analyze the signals from the sensors and provide necessary medical treatment for the patient (Abstract, computer analyzing select physiological variables of a patient in real time in order to alert medical personnel to the need for medical treatment or automatically administering such treatment under computer control; Paragraph 3, The coded signals generated by the signal analyzing module are next analyzed by a decision module (which may be a separate computer or a software module) which, from the information contained in such coded signals, generates an evaluation of the patient's present condition. If such evaluation indicates the need for medical treatment, the decision module activates a display or alarm to alert medical personnel or activates an actuation device for administering the treatment automatically under computer control).
Regarding Claim 9, the primary reference of Chang and the secondary reference of Lemelson does not expressly disclose the frequencies of the two sampling rates, Pinhas teaches the real-time monitoring device for human body of claim 8, wherein the first sampling rate is not greater than 4 KHz, and the second sampling rate being not greater than 120 Hz (Pinhas | Paragraph 0186, Data acquisition module 20 typically comprises circuitry for processing the raw motion signal generated by motion sensor 30, such as at least one pre-amplifier 32, at least one filter 34, and an analog-to-digital (A/D) converter 36. Filter 34 typically comprises a band-pass filter or a low-pass filter, serving as an anti-aliasing filter with a cut-off frequency of less than one half of the sampling rate. The low-passed data is typically digitized at a sampling rate of at least 10 Hz and stored in memory. For example, the anti-aliasing filter cut-off may be set to 10 Hz and the sampling rate set to 40 Hz. For some applications, filter 34 comprises a band-pass filter having a low cutoff frequency between about 0.03 Hz and about 0.2 Hz, e.g., about 0.05 Hz, and a high cutoff frequency between about 1 Hz and about 10 Hz, e.g., about 5 Hz… motion sensor 30 is additionally used for registration of acoustic signals, for which a frequency passband of about 100 Hz to about 8 kHz is useful; [Examiner’s note, as shown in Figure 2, both the motion sensor 30 and acoustic sensor 110 go through the motion data acquisition module 20.]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang in view of Lemelson to incorporate the teachings of specific sampling rate for a sound signal and motion signal exhibited by the patient from Pinhas. Thus the frequences of the sampling rates allow for an accurate analysis of the targeted signal. Doing so would allow the removal of background noise collected from the sensor and provide the system to accurately analyze the signals to provide the correct treatment for the patient (Paragraph 0067, monitoring patients for the occurrence or recurrence of a physiological event, for example, a chronic illness or ailment, that can assist the patient or healthcare provider in treating the ailment or mitigating the effects of the ailment. By means of automated sensors and electronic signal processing, aspects of the invention detect vital, and not so vital, signs to detect and characterize the onset of a physiological event and, in some aspects, treat the event, for example, with therapy or medication).
Claim 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Lemelson, further in view of US Patent Application 20170156594 A1 to Stivoric et al (herein Stivoric).
Regarding Claim 16, Chang in view of Lemelson teaches the real-time monitoring device for human body of claim 15, further comprising:
an article supporting unit, being disposed in the second accommodation space (Chang | Paragraph 0034, Second compartment 206 can be placed on the top of the subject's clothing and secured to the clothing by, for example, buttons, straps or a hook and loop fastener such as Velcro®, or can be placed in a pocket or pouch that is secured to the infant's clothing)
Chang in view of Lemelson fails to expressly teach of a platform; a plurality of supporting rods; wherein the platform is faced to a bottom of the second accommodation space, and the second circuit assembly being positioned in a space formed by the plurality of supporting rods and a bottom surface of the platform.
However, Stivoric teaches consisting of a platform (Stivoric | lower housing – element 100) and a plurality of supporting rods (Stivoric | alignment pins – elements 145, 146 and alignment pin supporting bosses – element 150, 151); wherein the platform is faced to a bottom of the second accommodation space, and the second circuit assembly being positioned in a space formed by the plurality of supporting rods and a bottom surface of the platform (Stivoric | Figure 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monitoring device of Chang in view of Lemelson to incorporate the teachings of a platform and supporting rods from Stivoric. Doing so would allow for the prevention of the components from moving within the device (Paragraph 0136, Alignment pins 145, 146 extend in a perpendicular orientation away from lower housing 100 to extend through the alignment notches 155, 156 of printed circuit board 140. By extending through the first and second alignment notches 155, 156 of printed circuit board 140, printed circuit board 140 is secured to lower housing 100 and is prevented from moving laterally with respect to first and second alignment pins 145, 146.).
Regarding Claim 17, Chang in view of Lemelson further modified by Stivoric teaches the real-time monitoring device for human body of claim 16, wherein the processor module further comprises:
a wireless charging module, being disposed on a top surface of the platform, and being coupled to the second circuit assembly (Chang | Paragraph 0054, monitoring device 400 can include metallic pads, for example gold plated pads, formed on the outer surface of housing 402, to facilitate recharging (by magnetic connection to a recharging plate) and possibly reprogramming of the device); and
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a battery, being coupled to the second circuit assembly (Chang | battery – element 424; [Examiner’s note, the battery is located within the second body which is coupled to the second circuit assembly]).
Annotated Figure 4 | The battery is coupled to the secondary circuit assembly (MCU) as shown in Figure 2B. One having ordinary skill in the art can determine the components shown in Figures 2B are the same components within the same compartments in Figures 4A because Paragraph 0081 discloses In the preceding detailed description, specific embodiments are described. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the claims. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense.
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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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791