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 .
Status of Claims
This action is in reply to the amendment filed on 08/27/25.
Claims 1, 5, 9, 13, 17 have been amended and are hereby entered.
Claims 3, 11 have been canceled.
Claims 1-2, 4-10, 12-17 are currently pending and have been examined.
This action is made final.
Foreign Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2021-0168585, filed on 11/30/21. Accordingly, a priority date of 11/30/21 has been given to this application.
Examiner Request
The Applicant is requested to indicate where in the specification there is support for amendments to claims should Applicant amend. The purpose of this is to reduce potential 35 USC 112(a) issues that can arise when claims are amended without adequate support in the specification. The Examiner thanks the Applicant in advance.
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 1-2, 4-10, 12-17 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.
Claims 1, 9, 7 are rejected for lack of adequate written description. Claims 1, 9, 17 recite functional steps for which the Applicant has not adequately described the steps in sufficient detail for one of ordinary skill in the art to conclude that the Applicant had possession of the invention.
MPEP 2161.01(I): When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. [...] If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2161.01- § 2163.07(b). […]
Specifically, Claim 1 recites “a CBT-I prescriber configured to determine a CBT-I program for insomnia treatment of the insomnia patient from among the plural CBT-I programs based on the sleep evaluation data”; Claim 9 similarly recites “determining a CBT-I program for insomnia treatment of the insomnia patient from among the plural CBT-I programs based on the sleep evaluation data”; Claim 17 similarly recites “to determine a CBT-I program for insomnia treatment of the patient from among the plural CBT-I programs based on the sleep evaluation data. The Applicant has provided no disclosure of how the sleep evaluation data is used to determine a CBT-I program for insomnia treatment of the patient from among plural CBT-I programs. Para. [0056] discloses that sleep evaluation data may be generated from biosignal data using “Time In Bed (TIB), Total Sleep Time (TST), Wake time After Sleep Onset (WASO), Sleep On Latency (SOL), Sleep Efficiency (SE), Number of Awakenings (NWAK), etc. as evaluation indexes.” Table 1 provides a list of CBT-I programs, e.g., Sleep Education, Sleep Hygiene, Stimulus Control.
The specification does not appear to disclose or describe any kind of formula, standard or metric for how sleep evaluation data of any particular value translates into a particular program recommendation of a program shown in Table 1. For example, how would a CBT-I program of the choices listed in Table 1 be determined for a patient with a Sleep Efficiency of 50% vs. a patient with Sleep Efficiency of 90%, or for a patient with a count of 5 “Number of Awakenings” vs. a count of 20 “Number of Awakenings”? Any analysis and subsequent determination could potentially read on the as-claimed invention.
The Specification states: [0062] “The CBT-I prescriber 2400 creates a CBT-I prescription for insomnia treatment. Specifically, the CBT-I prescriber 2400 may determine a CBT-I program for treating patient's insomnia among a plurality of CBT-I programs stored in the database 2100 based on the sleep evaluation data for the insomnia patient”; [0074] In S3400, a CBT-I prescription is generated. Specifically, the CBT-I treatment server 1200 may determine a CBT-I program for treating the insomnia patient based on the sleep evaluation data. The CBT-I treatment server 1200 may generate a CBT-I prescription including the determined CBT-I program”. This is inadequate for a person of ordinary skill in the art at the time of the invention (or filing) to conclude that the Applicant had possession of the claimed algorithm. No algorithm is presented.
The Examiner prospectively notes that this written description rejection is not based on whether one skilled in the art would know how to program a computer to perform any form of analysis and determination (i.e., an enablement rejection), but rather is directed to the Applicant’s lack of specificity as to how the analysis and/or determination is specifically performed with respect to the Applicant’s claimed invention. In this case, the Applicant's description of analysis and determination claims any and all types of analysis and determination evidencing that the Applicant did not have possession of their invention at the time of filing.
Dependent Claims 2, 4-8, 10-16 inherit the deficiencies of their respective parent claims and are subsequently rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-10, 12-17 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-2, 4-8 are drawn to a server, Claims 9-10, 12-16 are drawn to a method, and Claim 17 is drawn to a system, each of which are within the four statutory categories. Claims 1-2, 4-10, 12-17 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
generating sleep evaluation data of an insomnia patient based on biosignal data comprising a change in a biosignal during sleep of the insomnia patient,
wherein the sleep evaluation data is generated by using one of the following algorithms: (i) an algorithm for analyzing sleep stages using heart rates and wrist movement of the insomnia patient, (ii) an algorithm for analyzing Rapid Eye Movement (REM) sleep stages using heart rate variability (HRV) derived from the heart rates of the insomnia patient, and (iii) an algorithm for classifying a sleep state and wakefulness state from a movement of the insomnia patient,
wherein the sleep evaluation data is generated according to at least one indicator of Time In Bed (TIB), Total Sleep Time (TST), Wake time After Sleep Onset (WASO), Sleep On Latency (SOL), Sleep Efficiency (SE) and Number of Awakenings (NWAK), wherein the SOL is an index considered when diagnosing sleep dysfunction when a time is more than 30 minutes based on 30 minutes from in-bed time to entering a sleep state, wherein the SE is an indicator of insomnia treatment criteria when a total sleep time/total in-bed time is less than 85%,
determining a CBT-I program for insomnia treatment of the insomnia patient from among the plurality of CBT-I programs based on the sleep evaluation data, wherein the CBT-I program includes one or more contents of video imagery and audio, and includes sleep education, sleep hygiene, stimulus control, sleep restriction, relaxation therapy, cognitive therapy, and light therapy, wherein the sleep education includes an explanation of the sleep process regarding a sleep structure and sleep needs and principles of biorhythms for sleep stages, wherein the sleep hygiene includes an explanation of hygiene education to be followed for sleep, wherein the stimulus control includes an explanation of relearning operations regarding bed and sleep, wherein the sleep restriction includes an explanation of limiting bed access time to increase sleep efficiency, wherein the relaxation therapy includes an explanation of any one of muscle relaxation therapy, breathing therapy, and meditation therapy to reduce physical tension, wherein the cognitive therapy includes an explanation of modifying information perceived by the insomnia patient regarding sleep, and wherein the light therapy includes an explanation of circadian rhythm.
generating a CBT-I prescription comprising the determined CBT-I program.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Using biosignal data of a patient to generate sleep evaluation data to use to determine a CBT-I program for insomnia for the patient and generating a prescription for the determined CBT-I program is a personal behavior that may be performed by a healthcare provider.
Claim 9 recites implementing the steps of:
generating sleep evaluation data of the insomnia patient based on the biosignal data comprising the change in the biosignal during sleep of the insomnia patient;
determining a CBT-I program for insomnia treatment of the insomnia patient from among the plural plurality of CBT-I programs based on the sleep evaluation data and generating a CBT-I prescription comprising the determined CBT-I program;
wherein the generating of the sleep evaluation data of the insomnia patient based on the biosignal data comprises generating the sleep evaluation data by using one of the following algorithms: (i) an algorithm for analyzing sleep stages using heart rates and wrist movement of the insomnia patient,(ii) an algorithm for analyzing REM sleep stages using heart rate variability (HRV) derived from the heart rates of the insomnia patient, and(iii) an algorithm for classifying a sleep state and wakefulness state from a movement of the insomnia patient,
wherein the generating of the sleep evaluation data of the insomnia patient based on the biosignal data comprises generating the sleep evaluation data according to at least one indicator of Time In Bed (TIB), Total Sleep Time (TST), Wake time After Sleep Onset (WASO), Sleep On Latency (SOL), Sleep Efficiency (SE) and Number of Awakenings (NWAK),wherein the SOL is an index considered when diagnosing sleep dysfunction when a time is more than 30 minutes based on 30 minutes from in-bed time to entering a sleep state, wherein the SE is an indicator of insomnia treatment criteria when a total sleep time/total in-bed time is less than 85%,wherein the CBT-I program includes one or more contents of video imagery and audio, including sleep education, sleep hygiene, stimulus control, sleep restriction, relaxation therapy, cognitive therapy, and light therapy, wherein the sleep education includes an explanation of the sleep process regarding a sleep structure and sleep needs and principles of biorhythms for sleep stages, wherein the sleep hygiene includes an explanation of hygiene education to be followed for sleep, wherein the stimulus control includes an explanation of relearning operations regarding bed and sleep, wherein the sleep restriction includes an explanation of limiting bed access time to increase sleep efficiency, wherein the relaxation therapy includes an explanation of any one of muscle relaxation therapy, breathing therapy, and meditation therapy to reduce physical tension, wherein the cognitive therapy includes an explanation of modifying information perceived by the insomnia patient regarding sleep, and wherein the light therapy includes an explanation of circadian rhythm.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Using biosignal data of a patient to generate sleep evaluation data to use to determine a CBT-I program for insomnia for the patient and generating a prescription for the determined CBT-I program is a personal behavior that may be performed by a healthcare provider.
Claim 17 recites implementing the steps of:
generating sleep evaluation data of an insomnia patient based on biosignal data including a change in a biosignal during sleep of the insomnia patient
determining a CBT-I program for insomnia treatment of the patient from among a plurality of CBT-I programs based on the sleep evaluation data, and
generating a CBT-I prescription comprising the determined CBT-I program;
wherein the sleep evaluation data is generated by using one of the following algorithms:(i) an algorithm for analyzing sleep stages using heart rates and wrist movement of the insomnia patient,(ii) an algorithm for analyzing REM sleep stages using heart rate variability (HRV) derived from the heart rates of the insomnia patient, and(iii) an algorithm for classifying a sleep state and wakefulness state from a movement of the insomnia patient,
wherein the sleep evaluation data is generated according to at least one indicator of Time In Bed (TIB), Total Sleep Time (TST), Wake time After Sleep Onset (WASO), Sleep On Latency (SOL), Sleep Efficiency (SE) and Number of Awakenings (NWAK), wherein the SOL is an index considered when diagnosing sleep dysfunction when a time is more than 30 minutes based on 30 minutes from in-bed time to entering a sleep state, wherein the SE is an indicator of insomnia treatment criteria when a total sleep time/total in-bed time is less than 85%,wherein the CBT-I program includes one or more contents of video imagery and audio, including sleep education, sleep hygiene, stimulus control, sleep restriction, relaxation therapy, cognitive therapy, and light therapy, wherein the sleep education includes an explanation of the sleep process regarding a sleep structure and sleep needs and principles of biorhythms for sleep stages, wherein the sleep hygiene includes an explanation of hygiene education to be followed for sleep, wherein the stimulus control includes an explanation of relearning operations regarding bed and sleep, wherein the sleep restriction includes an explanation of limiting bed access time to increase sleep efficiency, wherein the relaxation therapy includes an explanation of any one of muscle relaxation therapy, breathing therapy, and meditation therapy to reduce physical tension, wherein the cognitive therapy includes an explanation of modifying information perceived by the insomnia patient regarding sleep, and wherein the light therapy includes an explanation of circadian rhythm.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Using biosignal data of a patient to generate sleep evaluation data to use to determine a CBT-I program for insomnia for the patient and generating a prescription for the determined CBT-I program is a personal behavior that may be performed by a healthcare provider.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
CBT-I treatment server implemented in a combination of hardware and software (Claims 1, 9, 17) as implementing the steps of the abstract idea
a sleep evaluator (of the server) as implementing the step of generating sleep evaluation data of an insomnia patient based on biosignal data comprising a change in a biosignal during sleep of the insomnia patient by using one of the algorithms in steps (i), (ii) or (iii) (Claim 1 and 9)
a CBT-I prescriber (of the server) as implementing the step of determining a CBT-I program for insomnia treatment of the insomnia patient from among the plural CBT-I programs based on the sleep evaluation data and generating a CBT-I prescription comprising the determined CBT-I program (Claim 1 and 9)
a CBT-I treatment server as implementing the steps of generating sleep evaluation data of an insomnia patient based on biosignal data including a change in a biosignal during sleep of the insomnia patient, determining a CBT-I program for insomnia treatment of the patient from among a plurality of CBT-I programs based on the sleep evaluation data, and generating a CBT-I prescription comprising the determined CBT-I program (Claim 17); and
a terminal of the insomnia patient as implementing the steps of receiving the CBT-I prescription from the CBT-I treatment server and to output the CBT-I program comprised in the CBT-I prescription (Claim 17)
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools. Regarding the CBT-I treatment server, the specification does not appear to describe any particulars. Para. [0094] discloses that the CBT-I treatment server may include “at least one element of a processor 5100, a memory 5200, a storage 5300, a user interface input 5400 and a user interface output 5500”, as well as “a network interface 5700 for accessing a network”. Para. [0094] further discloses, “The processor 5100 may be a CPU or semiconductor element that executes processing instructions stored in the memory 5200 and/or the storage 5300. The memory 5200 and the storage 5300 may include various types of volatile/nonvolatile memory media. For example, the memory may include ROM 5240 and RAM 5250.” Therefore, this element is given its broadest reasonable interpretation as a general purpose computing element functioning in its ordinary capacity. Regarding the “sleep evaluator” and “CBT-I prescriber”, these are both understood to be a component of the CBT-I treatment server per para. [0051]. No particulars or structure of either the sleep evaluator or CBT-I prescriber are given. Therefore, these elements are given their broadest reasonable interpretation as a general purpose computing element. Regarding the “terminal” of the insomnia patient, no particulars appear to be disclosed. Therefore, it is given its broadest reasonable interpretation as a general purpose computing device functioning in its ordinary capacity. The above elements are not sufficient to integrate the judicial exception into a practical application.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
The independent claims also recite:
a database configured to store a plurality of CBT-I programs for insomnia treatment (Claim 1)
a CBT-I treatment server comprising a database for storing a plurality of CBT-I programs for insomnia treatment (Claim 9)
The above elements only constitute extra-solution activity. As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the element of a database storing a plurality of CBT-I programs is only nominally or tangentially related to the process of to the process of using biosignal data of a patient to determine a CBT-I program for insomnia for the patient and generating a prescription for the determined CBT-I program, and accordingly constitutes insignificant extra-solution activity.
The independent claims also recite:
a communicator configured to receive a biosignal from a biosignal collection device for generating biosignal data by sensing a change in a biosignal during sleep of the insomnia patient (Claim 1)
receiving, by a communicator of the server, a biosignal from a biosignal collection device for collecting biosignal data comprising a change in a biosignal during sleep of an insomnia patient (Claim 9)
The above elements only amount to mere data gathering and constitute extra-solution activity.
The independent claims also recite:
a communicator configured to transmit the CBT-I prescription to an insomnia patient’s terminal (Claim 1)
transmitting, by the communicator of the server, the CBT-I prescription to an insomnia patient’s terminal (Claim 9)
The above elements only constitute extra-solution activity. As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the steps of transmitting a CBT-I prescription to a patient’s terminal and transmitting collected biosignal data are only nominally or tangentially related to the process of using biosignal data of a patient to determine a CBT-I program for insomnia for the patient and generating a prescription for the determined CBT-I program, and accordingly constitute insignificant extra-solution activity.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Claims 1, 9 and 17, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 17 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the aforementioned steps/elements listed under Step 2A Prong 2, B. Insignificant Extra-Solution Activity, above, only amount insignificant extra-solution activity in the forms of mere data gathering, insignificant extra-solution activities that are incidental to the primary process or product that are merely a nominal or tangential addition to the claim, or insignificant application.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity the elements in Section B
above constitute well-understood, routine and conventional activity.
The elements of a database configured to store a plurality of CBT-I programs for insomnia treatment (Claim 1) and a database for storing a plurality of CBT-I programs for insomnia treatment (Claim 9) only amount to storing and/or retrieving information in memory, which have been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
The elements of a communicator configured to receive a biosignal from a biosignal collection device for generating biosignal data by sensing a change in a biosignal during sleep of the insomnia patient (Claim 1), receiving a biosignal from a biosignal collection device for collecting biosignal data comprising a change in a biosignal during sleep of an insomnia patient (Claim 9), a communicator configured to transmit the CBT-I prescription to an insomnia patient’s terminal (Claim 1), transmitting the CBT-I prescription to an insomnia patient’s terminal (Claim 9) only amount to transmitting/receiving data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, Claims 2, 10 recite limitations which further narrow the scope of the independent claims.
Claim 4 recites further comprising generating a sleep diary of the insomnia patient based on the sleep evaluation data, which is also certain methods of organizing human activity including personal behavior, as a healthcare provider may use sleep evaluation data of a patient to generate a sleep diary. Claim 4 recites “sleep diary manager” as implementing this step. This element is understood to be a general purpose computing element and amounts to mere instructions to apply the abstract idea using a computer. Claim 4 also recites wherein the communicator transmits the sleep diary to the insomnia patient’s terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional
activity given that it amounts to receiving or transmitting data over a network, which has been
previously held to be well-understood, routine and conventional when claimed at a high level of
generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 5 recites limitations pertaining to wherein the communicator further receives at least one of age information, gender information, smoking information, drinking level, exercise information, caffeine information, and nap information of the insomnia patient from the insomnia patient’s terminal, which amounts to insignificant extra-solution activity in the form of mere data gathering. Additionally, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). Claim 5 also recites the CBT-I prescriber further comprises at least one of age information, gender information, smoking information, drinking level, exercise information, caffeine information, and nap information of the insomnia patient, which further narrows the scope of the abstract idea. Claim 5 also recites determines a CBT-I program for insomnia treatment of the patient, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider may determine a CBT-I program to treat a patient’s insomnia. The above limitations are not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 6 recites wherein the communicator transmits the CBT-I prescription to an expert terminal and receives feedback, inputted by an insomnia treatment expert, for the CBT-I prescription from the expert terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 7 recites limitations pertaining to when the feedback comprises correction information on the CBT-I prescription, correcting the determined CBT-I program based on the correction information, and generating a corrected CBT-I prescription comprising the corrected CBT-I program, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider may correct a CBT-I program based on corrected information. Claim 7 recites the CBT-I prescriber as performing this step. As discussed above with respect to Claim 1, this amounts to mere instructions to implement the abstract idea on a computer. Claim 7 also recites the communicator transmits the corrected CBT-I prescription to the insomnia patient’s terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 8 recites when the feedback does not comprise correction information on the CBT-I prescription, the communicator transmits the CBT-I prescription comprising the determined CBT-I program to the insomnia patient’s terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 12 recites further comprising generating a sleep diary of the insomnia patient based on the sleep evaluation data, which is also certain methods of organizing human activity including personal behavior, as a healthcare provider may use sleep evaluation data of a patient to generate a sleep diary. Claim 12 also recites wherein the transmitting of the CBT-I prescription further comprises transmitting the sleep diary to the insomnia patient’s terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 13 recites limitations pertaining to further comprising receiving at least one of age information, gender information, smoking information, drinking level, exercise information, caffeine information, and nap information of the insomnia patient from the insomnia patient’s terminal, wherein, in the generating of the CBT-I prescription, at least one of age information, gender information, smoking information, drinking level, exercise information, caffeine information, and nap information of the insomnia patient is further comprised, which further narrows the scope of the abstract idea. Claim 13 also recites limitations pertaining to a CBT-I program for insomnia treatment of the patient is determined, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider may determine a CBT-I program to treat a patient’s insomnia. The above limitations are not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 14 recites limitations pertaining to further comprising transmitting the CBT-I prescription to an expert terminal and receiving feedback, inputted by an insomnia treatment expert, for the CBT-I prescription from the expert terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 15 recites when the feedback comprises correction information on the CBT-I prescription, correcting the determined CBT-I program based on the correction information, and generating a corrected CBT-I prescription comprising the corrected CBT-I program, which is also certain methods of organizing human activity including managing personal behavior, as a healthcare provider may correct a CBT-I program based on corrected information. Claim 15 also recites wherein, in the transmitting of the CBT-I prescription, the corrected CBT-I prescription is transmitted to the insomnia patient’s terminal, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 16 recites limitations pertaining to wherein, in the transmitting of the CBT-I prescription, the CBT-I prescription comprising the determined CBT-I program is transmitted to the insomnia patient’s terminal when the feedback does not comprise correction information on the CBT-I prescription, which comprises an additional element in the form of insignificant extra-solution activity. In addition to constituting extra-solution activity, the above limitation constitutes well-understood, routine and conventional activity given that it amounts to receiving or transmitting data over a network, which has been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II). This is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
The dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea or amount to insignificant extra-solution activity. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Dependent claims 2, 4-8, 10, 12-16, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-2, 4-10, 12-17 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-5, 9-10, 12-13, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naujokat et. al. (US Publication 20120238800A1) in view of Capodilupo et. al. (US Publication 20220273232A1), further in view of Pronk et. al. (US Publication 20150037769A1), and further in view of Sepah (US Publication 20150257697A1).
Regarding Claim 1, Naujokat discloses:
A Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment server implemented in a combination of hardware and software ([0013] teaches on a system structured to facilitate CBT for a patient having insomnia, e.g., CBT-I; utilizing multiple “processing units” (interpreted as hardware) to implement the steps of the method; [0095] teaches on the fourth processing unit including a memory device (hardware) having stored thereon a plurality of therapeutic interaction modules which are interpreted as software); and
a database configured to store a plurality of CBT-I programs for insomnia treatment ([0095]-[0096] teach on a processing unit including a memory device having stored thereon a plurality of interactive therapeutic instruction modules which are associated with insomnia related factors);
a sleep evaluator configured to generate sleep evaluation data of an insomnia patient based on biosignal data comprising [biosignal data] during sleep of the insomnia patient ([0032] teaches on using an ECG sensor for vital sign monitoring of the patient while sleeping; [0066] teaches on how the ECG signals (“biosignal data”) are processed; [0086] teaches on using a sensor (e.g., ECG) to detect sleeping activity data, e.g. determining/estimating if the patient is awake or asleep; [0090] further teaches on a first processing unit (“sleep evaluator”) converting the sleeping activity data into sleep pattern data (“sleep evaluation data”) including time in bed, total sleep time, total wake time, sleep efficiency, onset latency, etc.)
a CBT-I prescriber configured to determine a CBT-I program for insomnia treatment of the insomnia patient from among the plural CBT-I programs based on the sleep evaluation data ([0123] teaches on analyzing a patient sleep profile to determine a course of therapy by identifying factors contributing to insomnia, identifying type of insomnia, determining severity, etc. and recommending to the patient, among other options, “an interactive course of therapy” (CBT-I program); [0095] teaches on the “fourth processing unit” analyzing the sleep profile and providing the course of therapy related to the patient sleep profile and is interpreted as reading on the “CBT-I prescriber”); and to generate a CBT-I prescription comprising the determined CBT-I program ([0124] teaches on analyzing the patient profile to determine a course of therapy includes providing a plurality of interactive therapeutic instruction modules, each related to an aspect of insomnia; based on the patient sleep profile, determining which of the interactive therapeutic instruction modules to be presented to the patient – Examiner interprets using a patient’s sleep profile to determine which module to present to the patient to read on “generate a CBT-I prescription comprising the determined CBT-I program”); and
a communicator configured to receive the biosignal from a biosignal collection device for generating the biosignal data by sensing [biosignal data] during sleep of the insomnia patient ([0085] teaches on a communication assembly (“communicator”) which is coupled to and in electrical communication with the system components via an electronic communication network; [0086] teaches on the sensor system being structured to detect sleeping activity data such as heart rate detected by ECG – e.g., biosignal data during sleep of the patient; [0087] teaches on the sensor system having at least one sensor (biosignal communication device) which is in communication with the communication assembly; each sensor produces a sensor signal having at least one feature, e.g., an ECG sensor) and to transmit the CBT-I prescription to the insomnia patient’s terminal ([0124] teaches on the system determining a course of therapy for a patient and presenting the course of therapy (CBT-I prescription) to the patient on a display, including a plurality of interactive ([0095] teaches on the fourth processing unit being in communication with the communication assembly and providing the course of therapy to the patient; [0098] teaches on the fourth processing unit presenting the therapeutic instruction modules on display 1014 which is coupled to and in electronic communication with the communication assembly);
wherein the sleep evaluator is configured to generate the sleep evaluation data by using one of the following algorithms: (i) an algorithm for analyzing sleep stages using heart rates and wrist movement of the insomnia patient, (ii) an algorithm for analyzing Rapid Eye Movement (REM) sleep stages using heart rate variability (HRV) derived from the heart rates of the insomnia patient, and (iii) an algorithm for classifying a sleep state and wakefulness state from a movement of the insomnia patient ([0032] teaches on the system for sleep/wake classification which is interpreted as classifying a sleep state and wakefulness state using body movement signals of the patients from a sensor; a pre-processing step filters and removes artifacts during preparation of the signals and the sleep/wake classifier unit classifies sleep/wake status according to the input data (sensor/movement data); per claim construction “using one of the following”, only one of i, ii, or iii is required);
wherein the sleep evaluator is configured to generate the sleep evaluation data according to at least one indicator of Time In Bed (TIB), Total Sleep Time (TST), Wake time After Sleep Onset (WASO), Sleep On Latency (SOL), Sleep Efficiency (SE) and Number of Awakenings(NWAK) ([0090] teaches on pre-processing sensor signal to convert sleep activity data into sleep pattern data, which is interpreted as “sleep evaluation data”, and may include “a patient's time in bed, a patient's total sleep time, a patient's total wake time, a patient's sleep efficiency, a patient's sleep onset latency, a patient's awakenings after sleep onset”).
wherein the SOL is an index considered when diagnosing sleep dysfunction when a time is more than 30 minutes based on 30 minutes from in-bed time to entering a sleep state ([0093] teaches on quantitative measures of insomnia, e.g., Sleep Onset Latency (SOL) being compared to a “standard threshold” of 30 minutes to assess the type of sleep disturbance (sleep initiation problem, sleep maintenance or early awakenings);
wherein the SE is an indicator of insomnia treatment criteria when a total sleep time/total in-bed time is less than 85% ([0093] teaches on quantitative measures of insomnia, e.g., sleep efficiency may be compared to standard thresholds e.g., 90% to assess whether the patient is sleeping in a consolidated way; [0075] teaches on setting the upper limit for sleep efficiency to 85%, which is interpreted as teaching that the standard threshold of [0093] could also be 85%);
wherein the CBT-I program includes one or more contents of video imagery and audio ([0014] teaches on providing CBT-I course of therapy on a display; [0096] teaches on therapeutic instruction modules associated with insomnia related factors; [0097], “Each interactive therapeutic instruction module 1060, 1062, 1064, 1066, 1068, 1070 contains three parts: (1) therapeutic advice, given on the first day a patient accesses a module, (2) the general information delivered in daily tips on the remaining days of the module, and (3) a goal setting section, accessible on the first day a patient accesses the module. The therapeutic advice consists of recommendations/interventions which are based on the standard CBT-I. The therapeutic advice and daily tips targets those factors that maintain the problems or make them worse by a particular patient and may be related to the goals identified by the patient”; [0098] teaches on presenting the organized therapeutic instruction modules on display), and includes sleep education (Fig. 7, [0026], [0126]-[0130], interpreted as “sleep education” as it deals with providing “regular sleep schedule coaching”), sleep hygiene (Fig. 12, para. [0031] teaches on “lifestyle module”; interpreted as it includes factors such as physical activity, alcohol, sleep, food/calorie intake, napping), stimulus control ([0096] teaches on stimulus control as a behavioral factor and “bed-sleep association”), sleep restriction ([0023], [0074]-[0076]), relaxation therapy ([0030], [0145]), cognitive therapy ([0028], [0137]-[0140])
wherein the sleep education includes an explanation of the sleep process regarding a sleep structure and sleep needs and principles of biorhythms for sleep (Fig. 7, [0026] show “sleep scheduling module” flow chart which determines irregular schedule or irregular sleep window length (sleep structure/sleep needs); [0126]-[0130] teach on the sleep scheduling module which assesses amount of sleep, regular rising time each morning (biorhythms), needing to catch up by sleeping longer (sleep needs) and provides sleep schedule coaching);
wherein the sleep hygiene includes an e