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 .
Priority
Claims 1-17 are deemed to have an effective filing date of November 24, 2022.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code (see, for example, paragraphs [0013]-[0014], [0021]-[0022], [0025]-[0027]); references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code (there are 20 websites with “https:”). See MPEP § 608.01 VII. The hyperlink in paragraphs [0013]-[0014], [0021]-[0022], and [0025]-[0027] of the originally-filed specification also cannot serve to disclose necessary structure for the claimed detection units (see MPEP 608.01 VII and 608.01(p)).
Claim Interpretation
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “detection unit”, “score calculation unit”, alert output unit”, “transmission unit”, “reception unit”, “output unit” in claims 1-17.
Because these claim limitations is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. With respect to the “detection unit”, an acceleration sensor in discussed in paragraphs [0028], [0035] and [0037]-[0038] of the originally-filed specification (OFS): reaction detection unit; and a blood oxygen detection unit is discussed as relying on technology indicated in a website in paragraph [0026] of the OFS. However, corresponding structures for other types of detection units were not found and it is unclear of those units are supported by the originally-filed specification. Paragraph [0057] spanning pages 46-47 of the originally-filed specification states that “all or a part of the monitoring system 1 may be realized by memory and a processor (e.g., a generic computer). Thus, most of the “units” of the wearable terminal may be realized by a computer. With respect to the management server, a server is a computer/software that provides information to other computers (see Merriam-Webster definition – www.merrium-webster.com).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it recites a computer program per se. MPEP 2106.03(I) states “a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category. To narrow the claim to those embodiments that fall within a statutory category, the claim can be amended to “non-transitory computer-readable storage medium” described in paragraph [0057] spanning pages 46-47 of the OFS.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-14 recite a monitoring system and therefore is a product.
Claim 15 recite a wearable terminal and therefore is a product.
Claim 16 recite a monitoring method and therefore a process.
Claim 17 recites a program and therefore is directed to a non-statutory subject matter as set forth above. However, claim 17, if amended to claim those embodiments that fall within a statutory category (e.g., “non-transitory computer-readable storage medium”), the following rejection of claim 17 is ineligible for the reasons provided below.
Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1, 15, 16, and 17 recite following limitations:
“calculate a severity evaluation score used for evaluating a severity of wearer of the wearable terminal”,
“output a consciousness disorder evaluation alert…the wearable terminal”
“transmit the severity of the evaluation score…to the management server”
“receive the evaluation score…severity of the evaluation score”
“output the severity of the evaluation score…used for calculating the severity of the evaluation score”
The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of “detection unit”, “score calculation unit”, “alert output unit”, “transmission unit”, “reception unit”, and “output unit” in claims 1, 15, and 17 and “program”. For the limitation of “management server” in claims 1, 15, and 17, all steps are being performed by the “units” as set forth above, and not the “management server”. For all “unit” limitations other than “detection unit”, the specification discloses the following in paragraph [0057] of the OFS:
All or the part of the monitoring system 1 may include a memory and a central processing unit (CPU), and may realize a function thereof in such a manner that a program for realizing a function of each unit included in each system is loaded to and executed by the memory.
Therefore, all “unit” limitations other than “detection unit” would be nothing more than a generic computer. That is, other than reciting that “detection unit” and other “units” (nothing more than a generic computer) are performing these tasks, nothing in the claim precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity. MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitations of “units” language, the claims encompass the medical professional gathering biological data, computing a severity score, evaluating patient’s condition based on the score, and providing evaluation results to a patient.
Step 2A Prong 2:
The claims recite “detection unit” and other “units” to perform the abstract steps. These “units” read on a computer implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The additional element of “detection unit” amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept.
Step 2B:
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraph [0057] does not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
The additional element of “detection unit” amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept as set forth above. The specification discloses acceleration sensor available in Apple Watch Series 7 (see [0013]) and blood pressure, body temperature, heart rate, and blood oxygen detection units are available in various websites (see [0013]-[0014], [0021]-[0022], [0025]-[0027]). As such, the additional element of “detection unit” is well known in the field of data measurement.
Dependent claims 2 and 4-14 further limit the abstract idea already indicated in independent claim 1 and they are ineligible for the same reasons provided for claim 1 above.
Regarding claim 3, the additional element of “input unit” is nothing more than a generic computer based on [0057] of the specification. Further, “detection unit” recited in claim 3 is well known in the field of data measurement and is supported under Berkheimer Option 1 (see paragraphs [0013]-[0014], [0021]-[0022], [0025]-[0027]) of the originally-filed specification).
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
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.
Claims 1 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2017/0360334 to Oksala et al. (hereinafter referred to as “Oksala”) in view of International Publication No. WO 2022/108712 to Hite et al. (published May 27, 2022 and hereafter referred to as “Hite”).
Regarding claim 1, Oksala discloses a monitoring system that includes a wearable terminal (e.g., paragraphs [0012]: detectors for performing measurements can be incorporated into the same device, advantageously to a wristband or chest worn device) and a management server to monitor a wearer of the wearable terminal (e.g., paragraph [0011]: the backend (e.g., cloud server, any computer or phone application) may provide the calculated results about the state of consciousness to an auxiliary device), wherein the wearable terminal includes: a detection unit configured to detect biological information of the wearer of the wearable terminal (e.g., paragraphs [0010]-[0015]: multiple detectors and sensors are provided to measure, determine and manage biosignals; and [0027]: monitoring is based on motion sensors, and sensors that provide heart rate data, blood pressure, blood oxygen saturation, and respiratory rate); a score calculation unit configured to calculate a severity evaluation score used for evaluating a severity of the wearer of the wearable terminal, based on the biological information of the wearer of the wearable terminal detected by the detection unit (e.g., paragraph [0015]: warning scores related to these biosignals can convert those inputs into composite risk scores which are capable of predicting serious adverse events); an alert output unit configured to output a consciousness disorder evaluation alert used for evaluating a consciousness disorder of the wearer of the wearable terminal (e.g., paragraphs [0030]-[0031]: where the alert is a physical stimulus to which the patient must respond); and a transmission unit configured to transmit the severity evaluation score calculated by the score calculation unit, and the biological information of the wearer of the wearable terminal used for calculating the severity evaluation score, to the management server (e.g., paragraphs [0010]: the device comprises a data transfer interface (such as wireless interface) for transferring measurement data to a backend/server; and [0025]-[0026]: wearable device 201 communicates wirelessly to backend 210; Fig. 1), the management server includes: a reception unit configured to receive the severity evaluation score, and the biological information of the wearer of the wearable terminal used for calculating the severity evaluation score, which are transmitted by the transmission unit (e.g., paragraphs [0011] and [0026]: Advantageously, the communication between the device 201 and the backend 210 is two-way so the arrangement is capable of providing feedback and implies reception of the warning score and the biological information of the wearer of 201); and an output unit configured to output the severity evaluation score, and the biological information of the wearer of the wearable terminal used for calculating the severity evaluation score, which are received by the reception unit (e.g., paragraph [0011]: backend 210 may provide and/or send calculated results about the state of consciousness implies that the warning score and biological information is output), the alert output unit is capable of outputting the consciousness disorder evaluation alert, the detection unit detects the biological information of the wearer of the wearable terminal and a reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert output by the alert output unit (e.g., paragraphs [0015] and [0030]-[0031]), the score calculation unit is capable of calculating the severity evaluation score which includes the evaluation of the consciousness disorder, based on the biological information of the wearer of the wearable terminal and the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert output by the alert output unit, which are detected by the detection unit (e.g., paragraphs [0030]-[0031]), and the transmission unit is capable of transmitting the severity evaluation score, which includes the evaluation of the consciousness disorder, calculated by the score calculation unit, and the biological information of the wearer of the wearable terminal and the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert used for calculating the severity evaluation score which includes the evaluation of the consciousness disorder, to the management server (e.g., paragraphs [0010] and [0025]-[0026]).
Oksala differs from the claimed invention in that it does not expressly disclose, in a case where the severity evaluation score, which does not include the evaluation of the consciousness disorder, calculated by the score calculation unit is equal to or more than a threshold value. However, Hite, in a related art: wearable continuous emergency monitoring system, teaches that the system may monitor multiple input signals utilizing both value thresholds and value trends to confirm potential medical events prior to engaging alarm logic or alert logic (e.g., paragraph [0225]); and that sensor analyze the vital sign data for thresholds or trendlines that are outside the acceptable range, and when the vital sign data is outside the acceptable range, the control logic activates alarm logic and/or alert logic (e.g., paragraphs [0288]-[0290]) where the alarm or alert may be a tactile/haptic alarm or vibratory alert configured to produce a vibratory stimulation to the user to gain the user’s attention to determine if they need medical assistance (e.g., paragraph [0301]). Accordingly, one of ordinary skill in the art would have recognized the benefits of obtaining a severity evaluation score prior to engaging alarm logic or alert logic and when the score/value is equal to or more than a threshold value (outside the acceptable value), activating an alarm in view of the teachings of Hite. Consequently, one of ordinary skill in the art would have modified the monitoring system of Oksala to obtain a severity evaluation score using vital sign data prior to engaging alarm logic or alert logic to gain the user’s attention to determine if they need medical assistance in view of the teachings of Hite that such was a well-known medical protocol in the emergency medical monitoring system art, and because the combination would have yielded a predictable result.
Referring to claim 15, Oksala discloses a wearable terminal used for monitoring a wearer of the wearable terminal (e.g., paragraphs [0012]: detectors for performing measurements can be incorporated into the same device, advantageously to a wristband or chest worn device) where the wearable terminal comprises the elements recited in claim 1 and interacts with a management server (see the rejection of claim 1 above).
Regarding claim 16, Oksala discloses a monitoring method of monitoring a wearer of a wearable terminal, the monitoring method comprising: a detection step of detecting biological information of the wearer of the wearable terminal, via the wearable terminal (e.g., paragraphs [0010]-[0015]: a device worn of a wrist or chest of a patient has multiple detectors/sensors provided to measure, determine and manage biosignals of the patient; and [0027]: monitoring is based on motion sensors, and sensors that provide heart rate data, blood pressure, blood oxygen saturation, and respiratory rate); a score calculation step of calculating a severity evaluation score used for evaluating a severity of the wearer of the wearable terminal, based on the biological information of the wearer of the wearable terminal detected by the detection step, by the wearable terminal (e.g., paragraph [0015]: warning scores related to these biosignals can convert those inputs into composite risk scores which are capable of predicting serious adverse events); an alert output step outputting a consciousness disorder evaluation alert used for evaluating a consciousness disorder of the wearer of the wearable terminal, by the wearable terminal (e.g., paragraphs [0030]-[0031]: where the alert is a physical stimulus to which the patient must respond); and a transmission step of transmitting the severity evaluation score calculated in the score calculation step, and the biological information of the wearer of the wearable terminal used for calculating the severity evaluation score, to a management server (e.g., paragraphs [0010]: the device comprises a data transfer interface (such as wireless interface) for transferring measurement data to a backend/server; and [0025]-[0026]: wearable device 201 communicates wirelessly to backend 210; Fig. 1); a reception step receiving the severity evaluation score, and the biological information of the wearer of the wearable terminal used for calculating the severity evaluation score, which are transmitted in the transmission step by the management server (e.g., paragraphs [0011] and [0026]: Advantageously, the communication between the device 201 and the backend 210 is two-way so the arrangement is capable of providing feedback and implies reception of the warning score and the biological information of the wearer of 201); and an output step outputting the severity evaluation score, and the biological information of the wearer of the wearable terminal used for calculating the severity evaluation score, which are received in the reception step, by the management server (e.g., paragraph [0011]: backend 210 may provide and/or send calculated results about the state of consciousness implies that the warning score and biological information is output), in the alert output step, the consciousness disorder evaluation alert is output (e.g., paragraphs [0013]: control data provide emission of a visual, auditory and/or physical stimulus; [0030]-[0031]: where the alert is a physical stimulus to which the patient must respond), in the detection step, the biological information of the wearer of the wearable terminal and a reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert output in the alert output step are detected (e.g., paragraphs [0015] and [0030]-[0031]), in the score calculation step, the severity evaluation score which includes the evaluation of the consciousness disorder is calculated, based on the biological information of the wearer of the wearable terminal and the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert output in the alert output step, which are detected in the detection step (e.g., paragraphs [0015] and [0030]-[0031]), and in the transmission, the severity evaluation score, which includes the evaluation of the consciousness disorder, calculated in the score calculation step, and the biological information of the wearer of the wearable terminal and the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert used for calculating the severity evaluation score which includes the evaluation of the consciousness disorder are transmitted to the management server (e.g., paragraphs [0010] and [0025]-[0026]).
Oksala differs from the claimed invention in that it does not expressly disclose, in a case where the severity evaluation score, which does not include the evaluation of the consciousness disorder, calculated in the score calculation step is equal to or more than a threshold value. However, Hite, in a related art: wearable continuous emergency monitoring system, teaches that the system may monitor multiple input signals utilizing both value thresholds and value trends to confirm potential medical events prior to engaging alarm logic or alert logic (e.g., paragraph [0225]); and that sensor analyze the vital sign data for thresholds or trendlines that are outside the acceptable range, and when the vital sign data is outside the acceptable range, the control logic activates alarm logic and/or alert logic (e.g., paragraphs [0288]-[0290]) where the alarm or alert may be a tactile/haptic alarm or vibratory alert configured to produce a vibratory stimulation to the user to gain the user’s attention to determine if they need medical assistance (e.g., paragraph [0301]). Accordingly, one of ordinary skill in the art would have recognized the benefits of obtaining a severity evaluation score prior to engaging alarm logic or alert logic and when the score/value is equal to or more than a threshold value (outside the acceptable value), activating an alarm in view of the teachings of Hite. Consequently, one of ordinary skill in the art would have modified the monitoring method of Oksala to obtain a severity evaluation score using vital sign data prior to engaging alarm logic or alert logic to gain the user’s attention to determine if they need medical assistance, and to modify that score with the reaction of the patient to the alert in view of the teachings of Hite that such was a well-known medical protocol in the emergency medical monitoring system art, and because the combination would have yielded a predictable result.
Referring to claim 17, Oksala discloses a program (e.g., paragraph [0009]: invention related to a computer program) causing a computer mounted in a wearable terminal used for monitoring a wearer of the wearable terminal to execute the steps of the monitoring method of claim 16 (e.g., claim 13: program of instructions perform the operations of the method and paragraph [0016]: the data processing can be implemented (at least partially) by the device which may be a wristband or chest worn device; and for the steps see rejection of claim 16 above).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Oksala in view of Hite as applied to claim 1 above, and further in view of US Patent No. 11,571,134 to Buller (EFD 04/17/2017; and hereinafter referred to as “Buller”).
Oksala in view of Hite teaches the monitoring system according to claim 1, wherein the biological information of the wearer of the wearable terminal detected by the detection unit includes a superficial body temperature of the wearer of the wearable terminal (e.g., paragraph [0016] of Oksala: skin temperature of the wearer/patient is monitored and detected), a heart rate of the wearer of the wearable terminal (e.g., paragraph [0016] of Oksala: heart rate of the wearer/patient is monitored and detected), a mean blood pressure of the wearer of the wearable terminal (e.g., paragraph [0016] of Oksala: blood pressure of the wearer/patient is monitored and detected), a blood oxygen concentration saturation of the wearer of the wearable terminal (e.g., paragraphs [0012] of Oksala: SpO2 parameter change is monitored and detected; and [0016] of Oksala: respiratory rate is monitored and detected), and the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert output by the alert output unit (e.g., paragraph [0016] of Oksala: active monitoring (i.e. stimulus-response) is monitored and detected). Oksala in view of Hite differ from the claimed invention in that its blood pressure is not described as a “mean” or average blood pressure. However, Buller, in a related medical art concerned with vital signs, teaches comparison of a mean vital signs such as temperature or heart rate was known to those skilled in the medical arts (e.g., column 19, lines 2-25 of Buller). Accordingly, one of ordinary skill in the art would have modified the blood pressure readings taught by Oksala in view of Hite to be an average or mean blood pressure in view of the teachings of Buller that taking the average over a period of time of vital signs is a well-known medical protocol, and because the combination would have yielded a predictable result.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Oksala in view of Hite and Buller as applied to claim 2 above, and further in view of US Patent Application Publication No. 2019/0385744 to Freeman et al. (hereinafter referred to as “Freeman”).
With respect to claim 3, Oksala in view of Hite and Buller teaches the monitoring system according to claim 2, wherein the detection unit includes a superficial body temperature detection unit configured to detect the superficial body temperature of the wearer of the wearable terminal, a heart rate detection unit configured to detect the heart rate of the wearer of the wearable terminal, a blood pressure detection unit configured to detect the mean blood pressure of the wearer of the wearable terminal, a blood oxygen concentration saturation detection unit configured to detect the blood oxygen concentration saturation of the wearer of the wearable terminal, and a reaction detection unit configured to detect the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert output by the alert output unit (e.g., paragraph [0016] of Oksala as modified by Hite and Buller), and the score calculation unit calculates the severity evaluation score which does not include the evaluation of the consciousness disorder, the superficial body temperature of the wearer of the wearable terminal detected by the superficial body temperature detection unit, the heart rate of the wearer of the wearable terminal detected by the heart rate detection unit, the mean blood pressure of the wearer of the wearable terminal detected by the blood pressure detection unit, and the blood oxygen concentration saturation of the wearer of the wearable terminal detected by the blood oxygen concentration saturation detection unit (e.g., paragraph [0019] of Oksala: device assessing the level of consciousness of a person both passively and actively where passive assessment is estimated using only the monitored movement and physiological signals while active assessment is performed after stimuli is provided, as modified by Hite and Buller), and calculates the severity evaluation score which includes the evaluation of the consciousness disorder, based on the age of the wearer of the wearable terminal accepted by the input unit, the superficial body temperature of the wearer of the wearable terminal detected by the superficial body temperature detection unit, the heart rate of the wearer of the wearable terminal detected by the heart rate detection unit, the mean blood pressure of the wearer of the wearable terminal detected by the blood pressure detection unit, the blood oxygen concentration saturation of the wearer of the wearable terminal detected by the blood oxygen concentration saturation detection unit, and the reaction of the wearer of the wearable terminal to the consciousness disorder evaluation alert detected by the reaction detection unit (e.g., paragraph [0019]: active assessment as modified by Hite and Buller). Oksala in view of Hite and Buller differ from the claimed invention in that the age of the patient is not input and the severity evaluation score is not based on the input age of the patient. However, Freeman, in a related art: medical device for estimating risk of patient deterioration, teaches that prior to monitoring a patient for deteriorating clinical conditions, the medical device receives (e.g., manually entered via a user interface) patient parameters descriptive of the patient and the patient’s medical history (e.g., paragraph [0089]) which may include the age, gender, race, familial history of the patient (e.g., paragraph [0091]; and that the deterioration risk assessment is further adjusted based on the patient’s medical history and demographics such as the patient’s age (e.g., paragraphs [0195] and [0272]: risk assessment engine is further adjusted by a factor of 1.2 due to the patient’s advanced age). Accordingly, one of ordinary skill in the art would have recognized the benefits of inputting a patient’s age via an input unit or interface, and using the patient’s age to calculate a severity evaluation score in view of the teachings of Freeman. Consequently, one of ordinary skill in the art would have modified the monitoring system of Oksala in view of Hite and Buller to comprise an input unit for accepting the age of the wearer of its monitoring device and to calculate the severity evaluation score using the inputted age in view of the teachings of Freeman that such was well-known to those in the medical risk assessment art, and because the combination would have yielded a predictable result.
As to claim 4, Oksala in view of Hite, Buller, and Freeman teach the monitoring system of claim 3, including the score calculation unit (e.g., paragraphs [0015] and [0030]-[0031] of Oksala as modified by Hite, Buller and Freeman), which would be capable of calculating the warning score using a point system as taught by Freeman and the Glasgow Coma Scale article (https://www.kango-roo.com/learning/3121/ dated 2016/06/15 and discussed in paragraph [0015] on page 12 of the originally-filed specification). With respect to the values of each biological information gathered, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the monitoring system as taught by Oksala, Hite, Buller, and Freeman so that the age score, temperature, score, mean blood pressure score, blood oxygen concentration score, and consciousness saturation score have values of 0 points, 1 point, 2 points, 3 points, 4, points, 5, points, 6 points, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for point system.
Allowable Subject Matter
Claims 5-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Dependent claim 5 recites a specific age range and a point value for ages from “less than 45 years” to “75 years or more” in order to calculate evaluation and severity of a consciousness disorder. As of the date of this action, the Examiner has not identified any reference that can be used singularly or in combination with another reference includes those references applied above to render a score calculation unit using the recited points to determine severity of a consciousness disorder.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2012/0161069 to Husen et al. is directed to consciousness monitoring where a person’s behavior (body movement, eye movement, speech) is monitored (e.g., abstract and paragraph [0012]) to determine full consciousness where an alarm is triggered when the analysis results in a value lower than a threshold level indicates that the patient is not in a state of full consciousness (e.g., paragraph [0035]).
US Patent Application Publication No. 2009/0069642 to Gao et al. is directed to a wearable wireless electronic patient data communications and physiological monitoring device where a wearable patient monitor may monitor physiological data including patient vitals and inputting patient-specific information) and acquire assessments of the patient (e.g., paragraphs [0070] and [0087]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792