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, see 7-10, filed 10/09/2025, with respect to the objection to Claims 1-3 have been fully considered and are persuasive. The objection to Claims 1-3 has been withdrawn. However, a new objection to Claims 1 and 3 has been made.
Applicant’s arguments, see page 10, filed 10/09/2025, with respect to the rejection to Claims 1-3 under 35 U.S.C. § 101 as being directed to or encompassing a human organism have been fully considered and are persuasive. The rejection to Claims 1-3 under 35 U.S.C. § 101 as being directed to or encompassing a human organism has been withdrawn.
Applicant’s arguments, see page 13, filed 10/09/2025, with respect to the rejection of Claim 1 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Abreu Oramas and Fredrickson.
Applicant’s arguments, see page 13, filed 10/09/2025, with respect to the rejection of Claims 2-4 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made to Claims 2-3 only in view of Abreu Oramas, Fredrickson, and Cox.
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 1-5 under 35 U.S.C. § 101 as being directed to non-statutory subject matter, the applicant has asserted that amendments were made to eliminate any interpretations that the processing could be performed by a human. However, while the claims were amended to specifically recite a processor, and the time-series patterns analysis means as well as the event estimation and prediction means are included as part of this processor, these amendments still amount to a recitation of the words "apply it" (or an equivalent) and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
The Applicant has also argued the newly added limitation “wherein the camera apparatus is configured to switch a camera to a monitoring state on a basis of the reception of the alert signal transmitted by the alert means” integrates the judicial exception into a practical application and that the Office overlooked the particular configuration of the camera apparatus switching on a basis of the reception of the alert signal in the previous analysis under 35 U.S.C. § 101. However, the applicant has provided no further supporting arguments for this conclusion. It is not clear how or why the camera apparatus switching configurations on a basis of the reception of the alert signal transmitted by the alert means improves the technology of the art, improves the functioning of the processor, effects a transformation or reduction of a particular article to a different state or thing, applies the judicial exception with, or by use of, a particular machine, adds a specific limitation other than what is well-understood, routine, conventional activity in the field, adds unconventional steps that confine the claim to a particular useful application, or adds any other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, all of which amount to integrating the judicial exception into a practical application.
For these reasons, the rejection of the claims under 35 U.S.C. § 101 is maintained.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
In Claim 1, “wherein at least one of the watcher terminal or the management server includes first vital data processor for receiving the vital data” should read “wherein at least one of the watcher terminal or the management server includes a first vital data processor for receiving the vital data”.
In Claim 3, “wherein the management server includes second vital data processor for performing data processing using the target quantitative information accumulated in the database” should read “wherein the management server includes a second vital data processor for performing data processing using the target quantitative information accumulated in the database”.
Appropriate correction is required.
Claim Interpretation
Claim 4 recites “wherein the time of the pulse stop of the person to be monitored who has not been given life-support measures is predicted when the temporal fluctuation pattern of the pulse rate becomes a pattern that a period in which the pulse rate continues to be high and a period in which the pulse rate continues to be low repeat irregularly”. The Examiner notes that the term “period” is a relative term regarding time. However, the specification in Fig. 4 provides a standard for ascertaining the requisite degree when it recites “a pulse rate greatly varies in a block-like manner one to two weeks before a pulse stops (a period in which the pulse rate continues to be high and a period in which the pulse rate continues to be low repeat irregularly)” in [0060]. One of ordinary skill in the art would have, at the effective filing date of the claimed invention, understood the word “period” to refer to a period of time on the order of a few weeks (e.g., 0-5 weeks). Therefore, the term “period” in Claim 4 will be interpreted in this rejection as referring to a period of 0-5 weeks.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function in the clause “vital change detection means”
“vital change detection means” is linked with the transitional word “for” and modified by the functional language “detecting, on a basis of a change in the vital data, a physical event including disease onset and a physical condition change”
“vital change detection means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on computer-implemented functional language in accordance with the disclosure of the applicant on [0051] as dedicated software and hardware ([0032]) programmed to compare vital data with a predetermined threshold/combine a plurality of vital sign measurements and detect transitions to different bodily states including awakening during sleep, onset of atrial fibrillation, anemia, heat stroke, syncope, signs of pulse stopping, and pulse stopping, and equivalents thereof.
Claim 1 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function in the clause “alert means”
“alert means” is linked with the transitional word “for” and modified by the functional language “generating an alert signal on a basis of the detection performed by the vital change detection means and notifying the watcher terminal of occurrence of an abnormality”
“alert means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0035] as dedicated software and hardware ([0032]) programmed to light up or blinking a warning light, display a warning on a screen, output a warning sound from a speaker, or a combination of these things on the basis of an output of the vital change detection means, and equivalents thereof.
Claim 3 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function in the clause “time-series pattern analysis means”
“time-series pattern analysis means” is linked with the transitional word “for” and modified by the functional language “conducting an analysis with time-series patterns based on the vital data in past as an explanatory variable and at least one of the disease information or the physical condition information at and after times when the time-series patterns were obtained as a response variable and finding a correlation”
“time-series pattern analysis means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0067] as dedicated software and hardware ([0032]) programmed to perform data processing with a large amount of target quantitative information regarding a large number of persons to be monitored stored in a database, wherein the huge amount of target quantitative information accumulated (big data) includes a graph indicating temporal changes in vital data of each of the measurement items, where it is determined which variables, among a large number of variables included in the disease information and the physical condition information, the time-series patterns affect, and equivalents thereof.
Claim 3 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function in the clause “event estimation and prediction means”
“event estimation and prediction means” is linked with the transitional word “for” and modified by the functional language “comparing a time-series pattern based on new vital data with the time- series pattern found by the time-series pattern analysis means to be correlated with at least one of the disease information or the physical condition information and estimating or predicting a physical event including disease onset and a physical condition change of a person to be monitored who has shown the new vital data”
“event estimation and prediction means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0069] as dedicated software and hardware ([0032]) programmed to compare a time-series pattern based on the new vital data with a past time-series pattern included in a previous analysis, and if it is determined that the two patterns are similar to each other, to estimate or predict that a physical event found to be correlated with the past time-series pattern (onset of a disease indicated by correlated disease information or a physical condition change indicated by correlated physical condition information) will occur to the person who has shown the new vital data, and equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is 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.
Claim 4 recites “A monitoring assistance method using the monitoring assistance system according to Claim 3 comprising: continuously obtaining vital data including data regarding a pulse from a wearable terminal configured to be worn by a person to be monitored”. It is unclear if this “vital data” and “wearable terminal configured to be worn by a person to be monitored” are the same vital data and wearable terminal recited in parent Claim 1, or different elements. For the purposes of substantive examination, it is presumed these are the same vital data and wearable terminal recited in parent Claim 1.
Claim 4 recites “storing the obtained vital data in a database as target quantitative information associated with disease information and physical condition information regarding the person to be monitored”. It is unclear if this “database” is the database recited in parent Claim 1, or a different database. For the purposes of substantive examination, it is presumed Claim 4 refers to the same database recited in Claim 1.
Claim 4 recites “wherein the time of the pulse stop of the person to be monitored who has not been given life-support measures is predicted when the temporal fluctuation pattern of the pulse rate becomes a pattern that a period in which the pulse rate continues to be high and a period in which the pulse rate continues to be low repeat irregularly”. The terms “high”, “low”, and “irregularly” are each a relative term which renders the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification in [0060] recites:
“It has been conventionally thought that when a person dies quietly in a bedridden state without taking life- support measures, a pulse rate is substantially constant as during sleep and gradually decreases toward an end of life. Contrary to this conventional common wisdom of those skilled in the art, the present inventors have found, as illustrated in Fig. 4A, that, even in a bedridden state, a pulse rate greatly varies in a block-like manner one to two weeks before a pulse stops (a period in which the pulse rate continues to be high and a period in which the pulse rate continues to be low repeat irregularly). On a day when death is declared, the pulse rate, which has become low, repeats irregular fluctuation at short intervals and the skin temperature decreases until the pulse stops as illustrated in Fig. 4B (indicated by an arrow in the figure).”
However, this description does not sufficiently explain what exactly qualifies as a “high” pulse rate, a “low” pulse rate, or what range of time qualifies as a “short” interval. While Fig. 4 provides a quantitative example of pulse rate ranges and time, it is still not clear what the applicant intends the metes and bounds of these terms to be. In addition, the claim recites “the pulse rate continues to be high” and “the pulse rate continues to be low” while never reciting an initial determination of the pulse rate being high and low, respectively. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein the time of the pulse stop of the person to be monitored who has not been given life-support measures is predicted when the temporal fluctuation pattern of the pulse rate becomes a pattern that a period in which the pulse rate is higher than an average and a period in which the pulse rate is lower than an average repeat in a non-cyclical manner”. This claim construction is supported by the specification in [0060].
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 1, the claim recites a monitoring assistance system. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
receiving the vital data to which an identification code of the wearable terminal is attached and performing data processing on the vital data
detecting, on a basis of a change in the vital data, a physical event including disease onset and a physical condition change
generating an alert signal on a basis of the detection performed by the vital change detection means and notifying the watcher terminal of occurrence of an abnormality
stores target information…in which the person to be monitored is associated with the wearable terminal, and stores target quantitative information…in which the vital data obtained by the wearable terminal is associated with the target information
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally receiving the vital data to which an identification code of the wearable terminal is attached and performing data processing on the vital data, e.g. by receiving the vital data and identification code visually and processing the data with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally detecting, on a basis of a change in the vital data, a physical event including disease onset and a physical condition change e.g., visually, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally generating an alert signal on a basis of the detection performed by the vital change detection means and notifying the watcher terminal of occurrence of an abnormality, e.g. visually or audibly, with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally storing target information, in which the person to be monitored is associated with the wearable terminal, and storing target quantitative information, in which the vital data obtained by the wearable terminal is associated with the target information, e.g. by rote memory, with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a wearable terminal configured to be worn by a person to be monitored and that continuously obtains vital data including data regarding a pulse
a camera apparatus that is communicably connected to the watcher terminal and that is provided in a living space of the person to be monitored
alert means for…
wherein the camera apparatus is configured to switch a camera to a monitoring state on a basis of the reception of the alert signal transmitted by the alert means
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a watcher terminal associated with the wearable terminal…
a management server communicably connected to at least one of the watcher terminal or the wearable terminal;
wherein at least one of the watcher terminal or the management server includes first vital data processing means processor for
wherein the first vital data processor includes vital change detection means for…
wherein the management server…
…in the database…
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a wearable terminal configured to be worn by a person to be monitored and that continuously obtains vital data including data regarding a pulse
a camera apparatus that is communicably connected to the watcher terminal and that is provided in a living space of the person to be monitored
alert means for…
wherein the camera apparatus is configured to switch a camera to a monitoring state on a basis of the reception of the alert signal transmitted by the alert means
a watcher terminal associated with the wearable terminal…
a management server communicably connected to at least one of the watcher terminal or the wearable terminal;
wherein at least one of the watcher terminal or the management server includes first vital data processing means processor for
wherein the first vital data processor includes vital change detection means for…
wherein the management server…
…in the database…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The wearable terminal is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/19/2023 (“Wearable terminals that can be worn on a wrist like wristwatches to measure a pulse rate, body temperature, and the like non-invasively without attaching electrodes to a human body have been proposed (e.g., PTL 1)”, [0003]).
The watcher terminal and first vital data processor is/are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/19/2023 (See element 50, Fig. 1; “The watcher terminal 50 is a terminal used by a watcher, who monitors the person to be monitored. The watcher may be, for example, a medical worker, a visiting medical worker, a family member of the person. When the person to be monitored is a resident of a nursing home, for example, the watcher terminal 50 may be, for example, a terminal used by a medical worker who looks after the resident or a terminal provided for an office of the nursing home.)”, [0030]; “the watcher terminal 50 includes reception means, transmission means (both are not illustrated), and first vital data processing means 51 as functional components”, [0032]; a computer terminal is a commercially available product]).
Dependent Claim 3 also fail to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea.
Dependent Claims 2-3 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 2-3 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 4, the claim recites a monitoring assistance method using the monitoring assistance system according to Claim 3. Thus, the claim is directed to process, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
continuously obtaining vital data including data regarding a pulse
storing the obtained vital data…as target quantitative information associated with disease information and physical condition information regarding the person to be monitored
performing, using the target quantitative information accumulated in the database, an analysis process for conducting…an analysis with time- series patterns based on the vital data as an explanatory variable and at least one of the disease information or the physical condition information at and after times when the time-series patterns were obtained as a response variable
comparing a time-series pattern based on new vital data with the time-series pattern found in the analysis process to be correlated with at least one of the disease information or the physical condition information
estimating or predicting a physical event including disease onset and a physical condition change of a person to be monitored who has shown the new vital data
wherein the time-series pattern based on the new vital data is a temporal fluctuation pattern of a pulse rate, wherein a time of a pulse stop of the person to be monitored who has not been given life-support measures is predicted as the physical event
wherein the time of the pulse stop of the person to be monitored who has not been given life-support measures is predicted when the temporal fluctuation pattern of the pulse rate becomes a pattern that a period in which the pulse rate continues to be high and a period in which the pulse rate continues to be low repeat irregularly
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally continuously obtaining vital data including data regarding a pulse, e.g. audibly, visually, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally storing the obtained vital data…as target quantitative information associated with disease information and physical condition information regarding the person to be monitored e.g. with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally performing, using the target quantitative information accumulated in the database, an analysis process for conducting…an analysis with time- series patterns based on the vital data as an explanatory variable and at least one of the disease information or the physical condition information at and after times when the time-series patterns were obtained as a response variable, with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally comparing a time-series pattern based on new vital data with the time-series pattern found in the analysis process to be correlated with at least one of the disease information or the physical condition information, with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally estimating or predicting a physical event including disease onset and a physical condition change of a person to be monitored who has shown the new vital data e.g. with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
“wherein the time-series pattern based on the new vital data is a temporal fluctuation pattern of a pulse rate, wherein a time of a pulse stop of the person to be monitored who has not been given life-support measures is predicted as the physical event” is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
“wherein the time of the pulse stop of the person to be monitored who has not been given life-support measures is predicted when the temporal fluctuation pattern of the pulse rate becomes a pattern that a period in which the pulse rate continues to be high and a period in which the pulse rate continues to be low repeat irregularly” is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
continuously obtaining vital data including data regarding a pulse from a wearable terminal worn by a person to be monitored
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
…in a database…
…through machine learning…
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
continuously obtaining vital data including data regarding a pulse from a wearable terminal worn by a person to be monitored
…in a database…
…through machine learning…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The wearable terminal is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/19/2023 (“Wearable terminals that can be worn on a wrist like wristwatches to measure a pulse rate, body temperature, and the like non-invasively without attaching electrodes to a human body have been proposed (e.g., PTL 1)”, [0003]).
Therefore, Claims 1-4 are not patent eligible 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Abreu Oramas (US 20190125264 A1, hereinafter Abreu Oramas) in view of Fredrickson et al (US 20190057189 A1, hereinafter Fredrickson).
Regarding Claim 1, Abreu Oramas discloses a monitoring assistance system (See Fig. 1) comprising:
a wearable terminal (Element 304, Fig. 3) configured to be worn by a person to be monitored (See Fig. 3) and that continuously obtains vital data including data regarding a pulse (“The wearable device 304 may be a smart bracelet or a smart watch and may include a battery (such as a coin cell battery “CR2025” or a rechargeable battery), one or more sensors, a transceiver, and a processing device. The one or more sensors may measure vital signs in real time. For example, the vital signs may include one or more of body temperature, pulse rate, respiratory rate, and blood pressure”, [0058]);
a watcher terminal (“For example, at least one watcher device may be an electronic communication device of a caregiver (such as a doctor, a nurse etc.) or a family member of the individual”, [0061]) associated with the wearable terminal (“the method may include transmitting, using the communication device, the at least one notification to at least one watcher device associated with the at least one watcher identifier”, Abstract); and
a management server (Element 102, Fig. 1) communicably connected to at least one of the watcher terminal or the wearable terminal (See Fig. 1; “the online platform 100 for facilitating monitoring of an individual based on at least one wearable device may be hosted on a centralized server 102, such as, for example, a cloud computing service. …users of the online platform 100 may include relevant parties such as, but not limited to, end users, caregivers of end users, family members and friends of end users, and administrators. Accordingly, in some instances, electronic devices operated by the one or more relevant parties may be in communication with the platform 100”, [0053]); and
wherein at least one of the watcher terminal or the management server includes first vital data processor (Element 204, Fig. 2) for receiving the vital data (Step 502, Fig. 5) to which an identification code of the wearable terminal is attached and performing data processing on the vital data (“the at least one physiological data may be associated with a user identifier of the individual”, [0073]),
wherein the first vital data processor includes
vital change detection means for detecting, on a basis of a change in the vital data, a physical event including disease onset and a physical condition change (See Step 1202, Fig. 12; “Thereafter, if the mobile application on the smartphone 1104 gets anomalies on the health/emotions values from the wearable device 1102 (like blood pressure too high)”, [0090]; “For example, the analyzing criterion may indicate an acceptable value and/or range corresponding to one or more physiological variables such as, but not limited to, heart rate, respiratory rate, Galvanic Skin Resistance (GSR), blood pressure, insulin level, EMG, EEG and so on…For example, a specification of anger in the analyzing criterion may be used to automatically identify relevant physiological correlates such as increased heart rate, increased perspiration (As reflected in lowered GSR values), changes in EMG/EEG waves and so on”, [0062]; the examiner notes this clause is being interpreted in light of the 112(f) interpretation above), and
alert means for generating an alert signal (Step 1216, Fig. 12) on a basis of the detection performed by the vital change detection means (Step 1202, Fig. 12) and notifying the watcher terminal of occurrence of an abnormality (“the alert notification may not be a simple text message, rather it may be like an amber alert, which produces a louder noise that is almost impossible to ignore by a listener”, [0045]; the examiner notes this clause is being interpreted in light of the 112(f) interpretation above),
wherein the management server stores target information in a database (Element 114, Fig. 1; “The centralized server 102 may communicate with other network entities, such as, for example, a mobile device 106 (such as a smartphone, a laptop, a tablet computer etc.), other electronic devices 110 (such as desktop computers, server computers etc.), databases 114 (such as medical database etc.)”, [0053]), in which the person to be monitored is associated with the wearable terminal, wherein the management server stores target quantitative information in the database, in which the vital data obtained by the wearable terminal is associated with the target information (“The smartphone 302 may include an application that may allow the individual to check the health data (such as body temperature, pulse rate, respiratory rate, and blood pressure) received from the wearable device 304. The application may be able to update in real time a database in the cloud with all the health data, along with the individual's location (provided by the smartphone's and/or wearable device's GPS) and information related to individual's mood”, [0059]).
Abreu Oramas discloses the claimed invention except for expressly disclosing a camera apparatus that is communicably connected to the watcher terminal and that is provided in a living space of the person to be monitored, and
wherein the camera apparatus is configured to switch a camera to a monitoring state on a basis of the reception of the alert signal transmitted by the alert means.
However, Fredrickson, which also discloses a monitoring assistance system (See Fig. 1), teaches a camera apparatus that is communicably connected (“the ARIS device 104 may initiate operation of the camera device 126 and stream video to the caregiver 3 ARIS device 104, the administrator 2 ARIS device 104, and/or the administrator computer 10”, [0076]) to the watcher terminal (Element 10, Fig. 1) and that is provided in a living space of the person to be monitored (See Fig. 3, where camera 126 is integrated into ARIS device 104, and see ARIS device 104 worn by the person to be monitored, Fig. 1; this means the camera is with the person in a living space), and
wherein the camera apparatus is configured to switch a camera to a monitoring state (“The administrator computer 10 may be configured to transmit commands to the ARIS device 104 through an input device 42 such as a keyboard. The commands may include initiation of video streaming”, [0037]) on a basis of the reception of the alert signal transmitted by the alert means (Step 404, Fig. 4; “In box 404, the ARIS device 104 may initiate an emergency protocol based on the determination of unusual activity associated with box 402. The emergency protocol may include one or more of the following: sending an alert”, [0074]; “the alert and response integration system may be remotely actuated by the administrator 2 and/or caregiver 3, which is beneficial as the user 1 of the alert and response integration system may not always be in a position to initiate video streaming”, [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the camera apparatus and camera configuration of Fredrickson to the system of Abreu Oramas, because the images and video provided by the camera apparatus can provide the basis for administrators and caregivers to determine the appropriate actions needed to assist the user, as taught by Fredrickson (“In certain aspects, the ARIS device 104 may stream video in real time to the administrator 2 and/or caregiver 3 so that they may take appropriate action based on the content of the video”, [0057]).
Regarding Claim 2, modified Abreu Oramas discloses the monitoring assistance system according to Claim 1. Modified Abreu Oramas discloses the claimed invention except for expressly disclosing wherein the watcher terminal is configured to set the camera apparatus in a monitoring state on a basis of a signal transmission. However, Fredrickson teaches wherein the watcher terminal is configured to set the camera apparatus in a monitoring state (“The administrator computer 10 may be configured to transmit commands to the ARIS device 104 through an input device 42 such as a keyboard. The commands may include initiation of video streaming”, [0037]) on a basis of a signal transmission (“Moreover, the administrator computer 10 and the ARIS device 104 may be configured to provide any type of communication therebetween”, [0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Abreu Oramas with the configuration of Fredrickson, because the images and video provided by the camera apparatus can provide the basis for administrators and caregivers to determine the appropriate actions needed to assist the user, as taught by Fredrickson (“In certain aspects, the ARIS device 104 may stream video in real time to the administrator 2 and/or caregiver 3 so that they may take appropriate action based on the content of the video”, [0057]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Abreu Oramas in view of Fredrickson, and further in view of Cox et al (US 20170235894 A1, cited in applicant’s IDS, hereinafter Cox).
Regarding Claim 3, Abreu Oramas discloses the monitoring assistance system according to Claim 1. Abreu Oramas discloses the claimed invention except for expressly disclosing wherein disease information and physical condition information are included as the target information for each person to be monitored,
wherein the watcher terminal is configured to update disease information and the physical condition information,
wherein the management server includes second vital data processor for performing data processing using the target quantitative information accumulated in the database, and wherein the second vital data processor includes,
time-series pattern analysis means for conducting an analysis with time-series patterns based on the vital data in past as an explanatory variable and at least one of the disease information or the physical condition information at and after times when the time-series patterns were obtained as a response variable and finding a correlation, and
event estimation and prediction means for comparing a time- series pattern based on new vital data with the time-series pattern found by the time-series pattern analysis means to be correlated with at least one of the disease information or the physical condition information and estimating or predicting a physical event including disease onset and a physical condition change of a person to be monitored who has shown the new vital data.
However, Cox, which also discloses a monitoring assistance system (Abstract) teaches wherein disease information and physical condition information are included as the target information for each person to be monitored (“the patient information for a patient may be retrieved and analyzed to extract features from the patient information indicative of patient characteristics, such as lifestyle information based characteristics, diagnoses, symptoms, clinical measures of the patient such as blood pressure, weight, height, temperature, white blood counts, blood glucose level, or any other measure of a patient's medical state, and the like”, [0234]),
wherein the watcher terminal is configured to update disease information and the physical condition information (“As noted above, the patient's EMRs, demographic information, lifestyle information, and the like, may be obtained from a variety of sources. EMR information may comprise information from medical service providers about medical services and procedures performed, medical diagnosis information from medical personnel coded in electronic medical records, lab test results, medication information from electronic medical records, pharmacy computing systems, or the like, allergy information from medical records, immunization information, social history information as may be obtained from questionnaires presented by medical personnel (e.g., information about siblings, sexual history, notes about home life, abuse, etc.), reconciliation information from medical records (e.g., records of encounters with the patient after a medical service is provided), medical billing information, insurance claims information, encounter information (e.g., office visits completed), appointment information, medical problem information (e.g., smoker), and the like”, [0171]),
wherein the management server includes second vital data processor for performing data processing using the target quantitative information accumulated in the database (“The patient information in the patient registry, such as registry 1434 in FIG. 14, is analyzed by machine learning mechanisms