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 .
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Regarding claim 1,
There are periods placed in the middle of the claim, where it should either be a comma or a semi-colon.
The word “calculating” should be lowercase in “and Calculating a predicted sleep evaluation index”
Regarding claim 2,
There are periods placed in the middle of the claim, where it should either be a comma or a semi-colon.
The word “the” should be lowercase in “and The processor calculates a sleep evaluation index for model building based on the time of each sleep stage”, “and The processor calculates the sleep evaluation index for model building calculated in the sleep evaluation index”, and “and The processor is based on the sleep evaluation prediction model equation”
The word “calculate” should be lowercase in “and Calculate the predicted sleep rating index at that time”
“predicted sleep rating index” should be “predicted sleep evaluation index”
Appropriate correction is required.
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.
Claims 1 and 2 recite the words “means” and “means for”.
“a heart rate signal measuring means for measuring the heart rate signal” → defined as a wearable sensor such as a wristwatch type or a sensor at the fingertip (see paragraph [0026])
“autonomic nerve calculation means for calculating the energy value of an extremely low frequency component (VLF)” → defined as a computer processor or program (see paragraph [0014])
“biometric signal detecting means for detecting the biometric signals of said user” → defined as a sensor (see paragraph [0015])
“means for determining each sleep stage of the user during sleep” → defined as part of a computer program (see paragraph [0014])
“means for calculating a sleep evaluation index” → defined as a part of a computer program (see paragraph [0008])
“means for constructing a sleep evaluation prediction model equation” → defined as part of a computer program (see paragraph [0008])
“means for proposing a sleep improvement plan” → defined as part of a computer program, shown on a display (see paragraph [0025])
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.
Claims 1 and 2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 2 fail to recite a transitional phrase. The Examiner cannot properly determine the metes and bounds of the claim. The placement of the transitional phrase (i.e. determining where the preamble begins and ends) and the type of transitional phrase (e.g. comprising, consisting essentially of, or consisting) will greatly affect how the claims are construed.
Claim 2 recites “a sleep improvement method characterized by the above”, however it is unclear what exactly above.
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 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, claims 1 and 2 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1 and 2 recite a series of steps or acts for a sleep improvement device that contribute to the improvement of sleep conditions by providing sleep improvement plans based on lifestyle improvements that suit the user to improve sleep conditions. Thus, claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1 and 2 recites at least one step or instruction for contributing to the improvement of sleep conditions by providing sleep improvement plans, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claimed steps of assessing a wake-up procedure and sedation levels in a patient can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Accordingly, each of Claims 1 and 2 recites an abstract idea.
Specifically, Claim 1 recites a sleep improvement device that contributes to the improvement of sleep conditions by providing sleep improvement plans based on lifestyle improvements that suit the user to improve sleep conditions comprising:
A heart rate signal measuring means for measuring the heart rate signal of said user
An autonomic nerve calculation means for calculating the energy value of an extremely low frequency component (VLF) of at least 0.003 to 0.04 Hz among the autonomic nerve components of the user, based on said heart rate signal measured by said heart rate signal measuring means
A biometric signal detecting means for detecting the biometric signals of said user
Means for determining each sleep stage of the user during sleep based on the biometric signals detected by said biometric signal detecting means, and determining the time of each sleep stage
Means for calculating a sleep evaluation index for model building based on the time of each sleep stage determined by said means for determining the sleep stage
Means for constructing a sleep evaluation prediction model equation specific to the user, based on said sleep evaluation index for model construction calculated by said means for calculating a sleep evaluation index and the energy value of said very low frequency component (VLF) at least before bed-entry calculated by said means for calculating an autonomic component
Calculating a predicted sleep evaluation index based on said sleep evaluation prediction model equation constructed by said means of constructing the sleep evaluation prediction model equation and the energy value of at least said extremely low frequency component (VLF) calculated by said means of calculating the autonomic nervous system thereafter
Based on the calculated predictive sleep evaluation index, the sleep improvement device is equipped with a means for proposing a sleep improvement plan through lifestyle improvement that at least raises the energy value of the extremely low frequency component (VLF) above a certain value (observation, judgement or evaluation, which is grouped as a mental process under the 2019 PEG);
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 and 2 is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1 and 2), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of:
A heart rate signal measuring means
An autonomic nerve calculation means
A biometric signal detecting means
Means for determining each sleep stage of the user
Means for calculating a sleep evaluation index
Means for constructing a sleep evaluation prediction model equation
Calculating a predicted sleep evaluation index
Means for proposing a sleep improvement plan through lifestyle improvement
Are generically recited computer elements in independent Claims 1 and 2 which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1 and 2 is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processor, sleep evaluation index, sleep evaluation prediction model, and proposing a sleep improvement plan as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 2 is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 and 2 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1 and 2 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of:
A heart rate signal measuring means
An autonomic nerve calculation means
A biometric signal detecting means
Means for determining each sleep stage of the user
Means for calculating a sleep evaluation index
Means for constructing a sleep evaluation prediction model equation
Calculating a predicted sleep evaluation index
Means for proposing a sleep improvement plan through lifestyle improvement
A processor
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification,
“a heart rate signal measuring means for measuring the heart rate signal” is defined on paragraph [0026]
“autonomic nerve calculation means for calculating the energy value of an extremely low frequency component (VLF)” is defined on paragraph [0014]
“biometric signal detecting means for detecting the biometric signals of said user” is defined on paragraph [0015]
“means for determining each sleep stage of the user during sleep” is defined on paragraph [0014]
“means for calculating a sleep evaluation index” is defined on paragraph [0008]
“means for constructing a sleep evaluation prediction model equation” is defined on paragraph [0008]
“means for proposing a sleep improvement plan” is defined on paragraph [0025]
Processor is described on paragraph [0008]
However, these limitations are generically described without structure or detailed drawings. Such computer components are well understood, routine and conventional.
Accordingly, in light of Applicant’s specification, the claimed terms:
A heart rate signal measuring means
An autonomic nerve calculation means
A biometric signal detecting means
Means for determining each sleep stage of the user
Means for calculating a sleep evaluation index
Means for constructing a sleep evaluation prediction model equation
Calculating a predicted sleep evaluation index
Means for proposing a sleep improvement plan through lifestyle improvement
A processor
Are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the heart rate signal measuring means, an autonomic nerve calculation means, a biometric signal detecting means, means for determining each sleep stage of the user, means for calculating a sleep evaluation index, means for constructing a sleep evaluation prediction model equation, calculating a predicted sleep evaluation index, means for proposing a sleep improvement plan, and a processor computing these steps. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 and 2 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claim 1 and the method of claim 2 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 and 2 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 2 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 and 2 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 and 2 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 and 2 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being obvious over Farringdon et al. (US 20100286532 A1) in view of Haakma (US 20180125418 A1).
Regarding claim 1, Farringdon et al. teaches a sleep improvement device that contributes to the improvement of sleep conditions by providing sleep improvement plans based on lifestyle improvements that suit the user to improve sleep conditions (“the central monitoring unit may also be adapted to generate and provide feedback to a recipient relating to management of an aspect of at least one of the individual’s health and lifestyle”, paragraph [0031]) comprising:
A heart rate signal measuring means (ECG sensor disclosed in prior art, see paragraph [0006]) for measuring the heart rate signal of said user (“measuring an ECG signal and other heart related parameters such as heart beats or heart rate”, paragraph [0003]);
Biometric signal detecting means (sensors disclosed in prior art, see paragraph [0026]) for detecting the biometric signals of said user (shown in Table 2, paragraph [0138]);
Means for determining each sleep stage (program in computer disclosed in prior art, paragraph [0029]) of the user during sleep based on the biometric signals detected by said biometric signal detecting means (“system can produce a record of when the user…slept…sleep levels”, paragraph [0141]);
Means for calculating a sleep evaluation index for model building based on the sleep stage (program in computer disclosed in prior art, paragraph [0029]) determined by said means for determining the sleep stage determined by said means for determining the sleep stage (“algorithms for generating continuous information relating to a variety of variables from the data received…ECG signal generated…used to calculate heart rate…such variables may include…sleep states, including in bed, sleep onset, sleep interruptions, wake, and out of bed”, paragraph [0135]);
Means for constructing a sleep evaluation prediction model equation specific to the user (program in computer disclosed in prior art, paragraph [0029]), based on said sleep evaluation index for model construction calculated by said means for calculating a sleep evaluation index (“a mathematical model is built that relates the raw data to the corresponding verifiable standard data…algorithms known as context detectors that predict various contexts…sleeping”, paragraph [0143]);
Calculating a predicted sleep evaluation index based on said sleep evaluation prediction model equation constructed by said means of constructing the sleep evaluation prediction model equation (“the models make predictions on, for example, a minute by minute basis…creating an overall model that integrates the minute by minute predictions”, paragraph [0144], [0145]);
Based on the calculated predictive sleep evaluation index, the sleep improvement device is equipped with a means for proposing a sleep improvement plan (display disclosed in prior art, paragraph [0098]) through lifestyle improvement (paragraph [0031]).
Farringdon et al. does not teach the device comprising of an autonomic nerve calculation means for calculating the energy value of an extremely low frequency component (VLF), and determining the time of each sleep stage.
However, Haakma teaches a sleep improvement device (“the present invention is particularly useful for…sleep quality”, paragraph [0078]) that contributes to the improvement of sleep conditions, comprising:
A heart rate signal measuring means (“requires a sensor that records movements and a sensor that can record the times at which the heart beats (e.g. wearable electrocardiogram, ECG)”, paragraph [0005]);
Autonomic nerve calculation means (“sleep staging based on HRV (heart-rate variability) is possible due to the dynamics between sympathetic and parasympathetic components of the autonomous nervous system during different sleep stages, which are reflected in the HRV”, paragraph [0005]) for calculating the energy value of an extremely low frequency component (VLF) of at least 0.003 to 0.04 Hz (“very low frequencies (VLF) can be as low as 0.003 Hz”, paragraph [0098]) among the autonomic nerve components of the user, based on said heart rate signal measured by said heart rate signal measuring means;
A biometric signal detecting means (“processing unit which processes the sensor signal and extracts therefrom a feature indicative of the subject’s physiological state”, paragraph [0036]);
Means for determining each sleep stage of the user during sleep based on the biometric signals detected by said biometric signal detecting means (“processing unit which processes the sensor signal and extracts therefrom a feature indicative of the subject’s physiological state…refer to a sleep stage”, paragraph [0036]), and determining the time of each sleep stage (“assigning a sleep stage to a current time period”, paragraph [0090]);
Means for calculating a sleep evaluation index for model building based on the time of each sleep stage determined by said means for determining the sleep stage (“the actual sleep monitoring as provided by the processing unit is usually based on feature extraction from a sensor signal. One or more features can be extracted and used for assigning a sleep stage to a current time period”, paragraph [0090]);
Means for constructing a sleep evaluation prediction model equation (“predicted operating time of the sensor and required accuracy level of a physiological state monitoring”, paragraph [0052]) specific to the user, based on said sleep evaluation index for model construction calculated by said means for calculating a sleep evaluation index and the energy value of said very low frequency component (VLF) (“sleep stage of a subject, e.g., changes at comparatively low frequencies”, paragraph [0048) at least before bed-entry calculated by said means for calculating an autonomic component (calculation can occur during or before bed-entry “wake”, see paragraph [0095]);
Calculating a predicted sleep evaluation index based on sleep evaluation prediction model equation constructed by said means of constructing the sleep evaluation prediction model equation and the energy value of at least said extremely low frequency compoment (VLF) calculated by said means of calculating the autonomic nervous system thereafter (“train a predictive model to separate between sleep stages”, paragraph [0006], paragraph [0048]).
Farringdon et al. in view of Haakma would also teach that based on the calculated predictive sleep evaluation index, the sleep improvement device is equipped with a means for proposing a sleep improvement plan through lifestyle improvement that at least raises the energy value of the extremely low frequency component (VLF) above a certain value (the VLF can be raised, as mentioned in Haakma, see paragraph [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the similar devices of Farringdon et al. that provides sleep improvement plans based on lifestyle improvements and of Haakma that calculate the energy value of a VLF component among nerve components of a user, in order to provide a user with a proposal for lifestyle improvements to raise the energy value of the VLF, and improve sleep quality.
Regarding claim 2, Farringdon et al. teaches a sleep improvement method that contributes to the improvement of sleep conditions by providing a sleep improvement plan through lifestyle improvement (“the central monitoring unit may also be adapted to generate and provide feedback to a recipient relating to management of an aspect of at least one of the individual’s health and lifestyle”, paragraph [0031]) suited to the user to improve sleep conditions comprising:
A heart rate signal measuring process for measuring the heart rate signal of the user by the prescribed heart rate signal measuring means (“measuring an ECG signal and other heart related parameters such as heart beats or heart rate”, paragraph [0003]), and wherein the processor performing signal processing calculates, based on the heart rate signal measured in the heart rate signal measuring process (paragraph [0008])
A biometric signal detection process for detecting biometric signals of the user by the prescribed biometric signal detection means (sensors disclosed in prior art, see paragraph [0026])
A sleep stage determination process in which the processor determines each sleep stage of the user during sleep based on the biometric signals detected in the biometric signal detection process (“system can produce a record of when the user…slept…sleep levels”, paragraph [0141]);
The processor calculates a sleep evaluation index for model building (“algorithms for generating continuous information relating to a variety of variables from the data received…ECG signal generated…used to calculate heart rate…such variables may include…sleep states, including in bed, sleep onset, sleep interruptions, wake, and out of bed”, paragraph [0135]);
Process for constructing a sleep evaluation prediction model equation specific to said user (“a mathematical model is built that relates the raw data to the corresponding verifiable standard data…algorithms known as context detectors that predict various contexts…sleeping”, paragraph [0143]);
Calculating the predicted sleep evaluation index (“the models make predictions on, for example, a minute by minute basis…creating an overall model that integrates the minute by minute predictions”, paragraph [0144], [0145]);
A sleep improvement plan being proposed through lifestyle improvement, having suggestion steps (display disclosed in prior art, paragraph [0098]) through lifestyle improvement (paragraph [0031])
Farringdon et al. does not teach the method comprising of an autonomic nerve calculation means for calculating the energy value of an extremely low frequency component (VLF), and determining the time of each sleep stage.
However, Haakma teaches a sleep improvement method (“the present invention is particularly useful for…sleep quality”, paragraph [0078]) that contributes to the improvement of sleep conditions, comprising:
A heart rate signal measuring process (“requires a sensor that records movements and a sensor that can record the times at which the heart beats (e.g. wearable electrocardiogram, ECG)”, paragraph [0005]), based on the heart rate signal measured in the heart rate signal measuring process (“sleep staging based on HRV (heart-rate variability) is possible due to the dynamics between sympathetic and parasympathetic components of the autonomous nervous system during different sleep stages, which are reflected in the HRV”, paragraph [0005]), and an energy value of an extremely low frequency component (VLF) of at least 0.003 to 0.04 Hz of the autonomic nervous system component of the user (“very low frequencies (VLF) can be as low as 0.003 Hz”, paragraph [0098])
A biometric signal detection process (“processing unit which processes the sensor signal and extracts therefrom a feature indicative of the subject’s physiological state”, paragraph [0036]);
A sleep stage determination process based on the biometric signals detected (“processing unit which processes the sensor signal and extracts therefrom a feature indicative of the subject’s physiological state…refer to a sleep stage”, paragraph [0036]), and determining the time of each sleep stage (“assigning a sleep stage to a current time period”, paragraph [0090])
The processor calculates a sleep evaluation index for model building based on the time of each sleep stage determined in the sleep stage determination process (“the actual sleep monitoring as provided by the processing unit is usually based on feature extraction from a sensor signal. One or more features can be extracted and used for assigning a sleep stage to a current time period”, paragraph [0090]) and based on the energy value of the very low frequency component (VLF) calculated in the autonomic component calculation process (“sleep stage of a subject, e.g., changes at comparatively low frequencies”, paragraph [0048) at least prior to bed entry (calculation can occur during or before bed-entry “wake”, see paragraph [0095]);
Process for constructing a sleep evaluation prediction model equation specific to said user (“predicted operating time of the sensor and required accuracy level of a physiological state monitoring”, paragraph [0052]);
Calculating the predicted sleep evaluation index (“train a predictive model to separate between sleep stages”, paragraph [0006], paragraph [0048])
Farringdon et al. in view of Haakma would also teach that based on the calculated predictive sleep evaluation index, the sleep improvement device is proposed through lifestyle improvement such that the energy value of the extremely low frequency component (VLF) (the VLF can be changed to different values, as mentioned in Haakma, see paragraph [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the similar methods of Farringdon et al. that provides sleep improvement plans based on lifestyle improvements and of Haakma that calculate the energy value of a VLF component among nerve components of a user, in order to provide a user with a proposal for lifestyle improvements to be able to set the energy value of the VLF to a certain value or more, and improve sleep quality.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791