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 .
Claim Interpretation
The MPEP states:
2111.04 "Adapted to," "Adapted for," "Wherein," "Whereby," and Contingent Clauses [R-10.2019]
II. CONTINGENT LIMITATIONS
The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.
The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed.
Claims 1, 9, and 15 as now amended have the contingent limitation “in a case where the value obtained by executing the predetermined filter processing on the second period heart rate data is not within a predetermined reference value range, determine the sleep state of the user based on a second period acceleration data acquired from the acceleration sensor in the second period and the acceleration threshold instead of the value obtained by executing the predetermined filter processing on the second period heart rate data and the heart rate threshold”. There is a contemplated scenario where the heart rate data is always within the predetermined reference value range. In that scenario, none of these functions are required.
Response to Arguments
Claim Objections
The claim objections have been withdrawn as the applicant has amended to address them.
35 USC § 103 Rejection
Regarding the 35 USC § 103 prior art rejection, the applicant’s arguments are not persuasive in view of a new grounds of rejection as necessitated by the applicant’s heavily amended claims. Ahmed et al. has been cited as follows to teach that toggling through different sensor types based on the accuracy of the heart rate detection of the sensors is known in the art:
“Almen discloses the invention but is silent as to a sensor including a pulse wave sensor configured to acquire heart rate data of a user and an acceleration sensor configured to acquire acceleration data indicating body motion of the user; and at least one processor configured to: a controller that acquires acquire, in a first period, a plurality of first period heart rate data from the pulse wave sensor, derive an acceleration threshold based on a first period acceleration data acquired from the acceleration sensor in the first period, in a case where the value obtained by executing the predetermined filter processing on the second period heart rate data is not within a predetermined reference value range, determine the sleep state of the user based on a second period acceleration data acquired from the acceleration sensor in the second period and the acceleration threshold instead of the value obtained by executing the predetermined filter processing on the second period heart rate data and the heart rate threshold; and based on a determination result of the sleep state of the user indicating that a sleep of the user is light, determine a recommended wake-up time for the user and start an alarm. Ahmed teaches it is known to use such a modification as set forth in figure 25, steps 2506, 2508, [0232], [0233] (especially [0233] which discloses toggling through different sensor types based on the accuracy of the heart rate detection of the sensors) to provide a device configured to select a different one of the modes when the confidence level is below a predetermined threshold (e.g. see [0233]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Ahmed in the system/method of Almen, since said modification would provide the predictable results of a device configured to select a different one of the modes when the confidence level is below a predetermined threshold”.
35 USC § 101 Rejection
Regarding the 35 USC § 101 rejection, applicant’s arguments filed 6/11/2026 are not persuasive.
The applicant argues that the alarm step puts the abstract idea into practical application. This is not found persuasive because an alarm is not a prophylaxis (treatment step) and corresponds to any other generic alert or notification. Alarms are output that fall into the category of post-solution activity as laid out in the 101 rejection below. They do qualify as practical application as they are not prophylaxis (treatment step).
The applicant also argues that the acquisition step could not be performed in the human mind or by pen and paper. The acquisition step falls into pre-solution activity of data gathering as laid out in the 101 rejection below, thus the acquisition step is not part of the abstract idea.
Last, the applicant argues on page 17: “The claim requires continuous acquisition of physiological signals from physical sensors, time-based processing across different periods, generation of corrected data groups and standard deviation data groups, derivation of thresholds based on such data, and conditional switching between different signal sources and thresholds. These operations require the claimed sensor configuration and processor-controlled signal processing and are not merely conceptual or mental steps”.
However, the altering of using one sensor, then another, is not an unconventional arrangement of sensors. Each sensor is still sensing their conventional physiological parameter, and the operation of switching between them is a nominal tie to a technical field as a clinician is capable of evaluating if a smartwatch sensor is nonfunctioning and, subsequently, choosing a different sensor to use in a monitoring process. This would be equivalent to a person in a sleep evaluation study where a clinician administers multiple sensors and then evaluates the quality of the data acquired by the sensors.
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 1-5, 9-13, 15-19, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-5, 9-13, 15-19, and 21-22 are directed to statutory subject matter as the claims recite an electronic device, sleep state determination method, and a non-transitory computer-readable recording medium.
Step 2A, Prong One
Regarding claims 1, 9, and 15, the recited steps are directed to a mental process and mathematical calculation of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I) and (III)).
Regarding claims 1, 9, and 15, the limitations of “generating a first corrected data group by executing predetermined filter processing on the acquired plurality of first period data; generating a standard deviation data group by executing predetermined statistical processing on the plurality of first period data; deriving a threshold based on the first corrected data group and the standard deviation data group that are generated; and determining a sleep state of the user based on the threshold and second period data acquired in a second period different from the first period, in a case where the value obtained by executing the predetermined filter processing on the second period heart rate data is not within a predetermined reference value range, determine the sleep state of the user based on a second period acceleration data acquired from the acceleration sensor in the second period and the acceleration threshold instead of the value obtained by executing the predetermined filter processing on the second period heart rate data and the heart rate threshold” are nothing more than a mental process or mathematical calculation as drafted. Filtering the biological signal data, deriving a threshold, and determining a sleep state of the user are directed to a mental process. For example, these steps are nothing more than a medical professional analyzing a patient’s sleep data to remove any outliers based on initial baseline data. The step of generating standard deviation data recites performing statistical processing, which is nothing more than statistical calculation of standard deviation.
Step 2A, Prong Two
For claims 1, 9, and 15, the judicial exception is not integrated into a practical application. In particular, the “sensor” (including a pulse wave and an acceleration sensor) perform the acquiring step. The sensing is recited at a high-level of generality and amounts to no more than pre-solution activity of data gathering. Additionally, the claims recite “at least one processor”. The processor is recited a high-level of generality and amounts to nothing more than generic processor (see [0028] and [0113] of the USPGPub. version of the specification). The “alarm” in claims 1, 9, and 15 is also recited at a high-level of generality and amounts to no more than post-solution activity of adjusting alarm based on the sleep state determination.
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.
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 claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The controller, heart rate sensor, and alarm disclosed by the applicant are well-understood, routine, and conventional. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). 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.
As discussed with respect to Step 2A Prong Two, “heart rate sensor” is are recited at a high level of generality and amounts to no more than pre-solution activity of data gathering. The specification discloses that pulse wave sensor detects plethysmogram that can be used for heart rate calculation (see [0030] and [0033]) and any known sensor that can detect a biological signal that can be used in determination of the recommended wake-up time (see [0107]), which demonstrates the well-understood, routine, conventional nature of “heart rate sensor.” Accordingly, the use of heart rate sensor for data gathering purpose is well-understood, routine, conventional activity is supported under Berkheimer Option 1.For the limitation of adjusting alarm based on the sleep state determination, court decisions cited in MPEP 2106.05(d)(II) indicate recomputing and readjusting alarm limit values is well-understood, routine, conventional activity. Accordingly, adjusting alarm based on the sleep state determination is an insignificant post-solution activity that is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-5, 10-13, 16-19, and 21-22 further limit the abstract idea already indicated in independent claims 1, 9, and 15 and they are ineligible for the same reasons provided for claims 1, 9, and 15 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
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.
Claim(s) 1, 9, 15, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almen (Pub. No.: US 2005/0177051 A1) in view of Ahmed et al. (Pub. No.: 2016/0324432 A1); hereinafter referred to as “Ahmed”.
Regarding claims 1, 9, and 15, Almen discloses an electronic device comprising: at least on processor (e.g. see figure 11 element 54, [0081]) configured to: that acquire a plurality of first heart rate data (e.g. see figure 13, [0085]-[0093], Specifically [0088] discloses “The essential theory of operation is that the heart rate data is first acquired by the monitor over a defined time interval”), generate a standard deviation data group by executing predetermined statistical processing on the plurality of first period heart rate data (e.g. see figure 13, [0085]-[0093], Specifically [0088] discloses “Awake parameters are then calculated, comprising the mean awake heart rate value and standard deviation thereof”), derive a heart rate threshold based on the first data group (e.g. see figure 13, [0085]-[0093], Specifically [0088] discloses “This transition 106 is marked by a decrease in heart rate 104 and is recognized by the device when the heart rate decrease passes a defined threshold 106, e.g., three standard deviations below the awake sleep state heart rate mean value. The threshold values of +/- three standard deviations from the local mean heart rate values are for illustrative purposes only. Those skilled in the art will readily comprehend that a number of threshold values may be used, depending on the particular user, etc.”), determine a sleep state of the user, based on the heart rate threshold and second period heart rate data acquired in a second period different from the first period (e.g. see figure 13, [0085]-[0093]) and based on a determination result of the sleep state of the user indicating that a sleep of the user is light, determine a recommended wake-up time for the user and start an alarm (e.g. see figure 15, step 322, [0096]).
Almen discloses the invention but is silent as to a sensor including a pulse wave sensor configured to acquire heart rate data of a user and an acceleration sensor configured to acquire acceleration data indicating body motion of the user; and at least one processor configured to: a controller that acquires acquire, in a first period, a plurality of first period heart rate data from the pulse wave sensor, derive an acceleration threshold based on a first period acceleration data acquired from the acceleration sensor in the first period, in a case where the value obtained by executing the predetermined filter processing on the second period heart rate data is not within a predetermined reference value range, determine the sleep state of the user based on a second period acceleration data acquired from the acceleration sensor in the second period and the acceleration threshold instead of the value obtained by executing the predetermined filter processing on the second period heart rate data and the heart rate threshold; and based on a determination result of the sleep state of the user indicating that a sleep of the user is light, determine a recommended wake-up time for the user and start an alarm. Ahmed teaches it is known to use such a modification as set forth in figure 25, steps 2506, 2508, [0232], [0233] (especially [0233] which discloses toggling through different sensor types based on the accuracy of the heart rate detection of the sensors) to provide a device configured to select a different one of the modes when the confidence level is below a predetermined threshold (e.g. see [0233]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Ahmed in the system/method of Almen, since said modification would provide the predictable results of a device configured to select a different one of the modes when the confidence level is below a predetermined threshold.
Almen discloses the claimed invention but is silent as to the controller generates a first corrected data group by executing predetermined filter processing on the acquired plurality of first period data. Ahmed teaches it is known to use such a modification as set forth in [0097] (“Exemplary systems include a processing module configured to filter the raw photoplethysmography data received from the light detectors to minimize contributions due to motion”) to minimize contributions due to exterior influences. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a pre-filter to account for extreme values as taught by Ahmed in the system/method of Almen, since said modification would provide the predictable results of minimizing contributions due to exterior influences.
Regarding claim 21, Almen discloses a communicator, wherein: the at least one processor is configured to send, via the communicator, the acquired plurality of first period heart rate data, the acquired second period heart rate data, the first period acceleration data acquired in the first period, and the second period acceleration data acquired in the second period to an external information device; and the predetermined filter processing, the predetermined statistical processing, the derivation of the heart rate threshold, and the derivation of the acceleration threshold, and the determination of the sleep state are executable by the external information device based on the data received by the external information device (e.g. see figures 1 and 2, element 10).
Regarding claim 22, Almen discloses based on a determination result received from the external information device indicating that the sleep of the user is light, the at least one processor is configured to receive alarm information from the information device and start the alarm (e.g. see figure 15, step 322, [0096]).
Claim(s) 2, 10, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almen in view of Ahmed et al. as applied to claim 1 above, and further in view of Russell et al. (Pub. No.: US 2018/0256094 A1); hereinafter referred to as “Russell”.
Regarding claims 2, 10, and 16, Almen in view of Ahmed discloses the claimed invention but is silent as to the predetermined filter processing includes processing for generating the first corrected data group by executing, as the predetermined filter processing, filter processing for replacing each of the acquired first period data with a minimum value of the first period data within a first window period. Russell teaches it is known to use such a modification as set forth in [0078] to determine a representative value for a respective type of heart rate (e.g. see [0078]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a pre-filter to account for extreme values as taught by Russell in the system/method of Almen in view of Ahmed, since said modification would provide the predictable results of determining a representative value for a respective type of heart rate.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
