DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed April 23, 2026 in response to the Office Action of December 23, 2025 has been acknowledged and entered.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8, line 15: insert “to” after configured
Appropriate correction is required.
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 1-5 and 7 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.
Claim 1 recites “wherein the processor is further configured to…prohibit outputting data when the probability is equal to or greater than the threshold” in lines 11-14, and then subsequently recites “an output interface is configured to provide the data from the processor”. The “output interface” limitation requires providing data from the processor, which directly contradicts the subsequent claim feature that requires the processor to “prohibit outputting data when the probability is equal to or greater than the threshold”. Clarification requested.
Claims 2-5 are rejected by virtue of their dependence from claim 1.
Claim 7 recites “output data corresponding to the vital sign associated with the detection signal responsive to the probability that the detection signal is classified into one of the plurality of classes being equal to or greater than a threshold, the probability being output from the inference model” in lines 10-13, and then subsequently recites “and prohibit outputting the data corresponding to a vital sign associated with the detection signal based on the second detection signal” in lines 14-15.
The limitation “output data corresponding to the vital sign…” directly contradicts the subsequent claim feature to “prohibit outputting the data corresponding to a vital sign…”. Clarification requested.
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, 3-5, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (WO 2006066337) (previously cited) in view of Schuijers (WO 2017178308) (previously cited) and Lane (US 20200237252).
Regarding claim 1, Armitstead teaches a vital sign obtaining device comprising: an input interface configured to receive, from a first sensor, a first detection signal corresponding to a vital sign of a subject, the first sensor configured to obtain the vital sign (Paragraph [0016] respiratory pressure sensor system and provides recordings of respiratory pressure during sleep); an inference model (Paragraph [0023] machine learning) configured to output a probability that the first detection signal is classified into each of a plurality of classes (See Paragraphs [0021]-[0023]); and a processor configured to output data corresponding to a vital sign associated with the first detection signal, (Paragraphs [0037] respiratory, signal is processed either onboard by the recording device or using a computer), responsive to the probability that the first detection signal is classified into one of the plurality of classes being equal to or greater than a threshold (Paragraph [0017] detection of such events may be determined from the duration of one or more regions of hyperpnoea when the duration of the hyperpnoea exceeds a threshold, or a statistic, of the duration of regions of hyperpnoea exceeds a threshold); and an output interface configured to provide the data from the processor (Paragraph [0009], [0016] display of recordings to physician using personal computer).
However, Armitstead does not teach wherein the input interface is configured “to receive, from a second sensor, a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject” and “wherein the processor is further configured to, based on the second detection signal having a state indicating the vital sign is obtained in an inappropriate situation, prohibit outputting the data when the probability is equal to or greater than the threshold”.
Schuijers, in a related field of endeavor, teaches a sleeping signal conditional device (Fig. 1, 100) configured to receive, from a second sensor (220), a second detection signal (120) corresponding to at least one of a level of consciousness of the subject or a resting state of the subject (i.e. sleep), and wherein the processor is configured to determine whether to output the data, based on the second detection signal. (Page 8, lines 24-33, In practice (not shown), in addition to providing the first sleep signal output 170, typically similar sleep output signals would be generated based on the conditioned signals from the second and further sensors using corresponding processing circuitry).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Armitstead to teach “wherein the interface is configured to receive, from a second sensor, a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject, and wherein the processor is configured to determine whether to output the data, based on the second detection signal” as taught by Schuijers. Doing so provides a conditioned output sleep signal based on the evaluation criteria of the system. (Page 8, lines 24-33).
Lane, in a related field of endeavor, teaches a vital sign detection system wherein the processor is further configured to, based on the second detection signal having a state indicating the vital sign is obtained in an inappropriate situation (Paragraph [0045] the subject is in a bed with relatively little motion), prohibit outputting the data when the probability is equal to or greater than the threshold. (Paragraph [0075] teaches using a Doppler filter to accept only reflected radar signals within a predetermined frequency range when determining the vital sign measurement. For example, objects having no motion, and hence no Doppler signal, are removed when performing the method so that only a moving object is analyzed. Hence, a person in a resting or sleep state, i.e., an object having no motion would not be analyzed, and therefore corresponding data would not be outputted.)
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the vital sign obtaining device of Armitstead to further teach wherein the processor is further configured to, “based on the second detection signal” of Schuijers, “having a state indicating the vital sign is obtained in an inappropriate situation, prohibit outputting the data when the probability is equal to or greater than the threshold” as contemplated by Lane. Doing so subtracts background noise associated with the motionless objects thereby improving the quality of the vital sign measurement. (Paragraph [0037]).
Regarding claim 3, Armitstead teaches wherein one of the plurality of classes is associated with an elapsed time from obtaining of the vital sign. (Paragraph [0039] epoch length).
Regarding claim 4, Armitstead teaches wherein the vital sign includes respiration information. (Paragraph [0020]).
Regarding claim 5, Armitstead teaches wherein the data includes an index for evaluating a disease sign of the subject. (Paragraph [0010] apnea-hypopnoea index).
Regarding claim 7, Armitstead teaches a non-transitory computer readable storage medium storing a computer program, the computer program comprising instructions which, when executed by a processor (Paragraphs [0016], [0037] computer) mounted on a vital sign obtaining device, cause the vital sign obtaining device to: receive, from a sensor, a detection signal corresponding to a vital sign of a subject, the sensor configured to obtain the vital sign (Paragraph [0016] respiratory pressure sensor system and provides recordings of respiratory pressure during sleep); input the detection signal to an inference model, (Paragraph [0023] machine learning) the inference model being configured to output a probability that the detection signal is classified into each of a plurality of classes (See Paragraphs [0021]-[0023]); and output data corresponding to a vital sign associated with the detection signal (Paragraph [0021]), responsive to the probability that the detection signal is classified into one of the plurality of classes being equal to or greater than a threshold, the probability being output from the inference model. (Paragraph [0017] detection of such events may be determined from the duration of one or more regions of hyperpnoea when the duration of the hyperpnoea exceeds a threshold, or a statistic, of the duration of regions of hyperpnoea exceeds a threshold).
However, Armitstead does not teach wherein to “receive, from a second sensor, a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject” and “prohibit outputting the data corresponding to a vital sign associated with the detection signal based on the second detection signal.”
Schuijers teaches a sleeping signal conditional device (Fig. 1, 100) configured to receive, from a second sensor (220), a second detection signal (120) corresponding to at least one of a level of consciousness of the subject or a resting state of the subject (i.e., sleep). (Page 8, lines 24-33, In practice (not shown), in addition to providing the first sleep signal output 170, typically similar sleep output signals would be generated based on the conditioned signals from the second and further sensors using corresponding processing circuitry).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Armitstead to teach “receive, from a second sensor, a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject” as taught by Schuijers. Doing so provides a conditioned output sleep signal based on the evaluation criteria of the system. (Page 8, lines 24-33).
Lane teaches a vital sign detection system that prohibits outputting the data corresponding to a vital sign associated with the detection signal based on the second detection signal (Paragraphs [0045], [0075] teaches using a Doppler filter to accept only reflected radar signals within a predetermined frequency range when determining the vital sign measurement. For example, objects having no motion, i.e., subject is in a bed with relatively little motion, and hence no Doppler signal, are removed when performing the method so that only a moving object is analyzed. Hence, a person in a resting or sleep state, i.e., an object having no motion would not be analyzed, and therefore corresponding data would not be outputted.)
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the vital sign obtaining device of Armitstead to teach to “prohibit outputting the data corresponding to a vital sign associated with the detection signal” as contemplated by Lane, “based on the second detection signal” of Schuijers. Doing so subtracts background noise associated with the motionless objects thereby improving the quality of the vital sign measurement. (Paragraph [0037] of Lane).
Regarding claim 8, Armitstead teaches a vital sign obtaining system comprising: a first sensor configured to output a first detection signal corresponding to a vital sign of a subject (Paragraph [0016] respiratory pressure sensor system and provides recordings of respiratory pressure during sleep); a management device configured to manage attribute information of the subject (Paragraph [0010] computer); an inference model (Paragraph [0023] machine learning) configured to output a probability that the first detection signal is classified into each of a plurality of classes (See Paragraphs [0021]-[0023]); an output interface (Paragraphs [0009], [0016]); and a processor configured to output, via the outface interface to the management device, data corresponding to the vital sign associated with the first detection signal, (Paragraphs [0037] respiratory, signal is processed either onboard by the recording device or using a computer) the probability that the first detection signal is classified into one of the plurality of classes being equal to or greater than a threshold, (Paragraph [0017] detection of such events may be determined from the duration of one or more regions of hyperpnoea when the duration of the hyperpnoea exceeds a threshold, or a statistic, of the duration of regions of hyperpnoea exceeds a threshold), wherein the management device is configured to store the data in association with the attribute information (Paragraph [0037] memory).
However, Armitstead does not teach wherein the interface is configured “a second sensor configured to output a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject” and “wherein the management device is configured to prohibit the storage of the data corresponding to the vital sign associated with the first detection signal responsive to receiving the second detection signal from the second sensor”.
Schuijers, as previously discussed, teaches a sleeping signal conditional device (Fig. 1, 100) comprising a second sensor configured to output a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject (i.e. sleep) (Page 8, lines 24-33, In practice (not shown), in addition to providing the first sleep signal output 170, typically similar sleep output signals would be generated based on the conditioned signals from the second and further sensors using corresponding processing circuitry).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Armitstead to teach “a second sensor configured to output a second detection signal corresponding to at least one of a level of consciousness of the subject or a resting state of the subject” as taught by Schuijers. Doing so provides a conditioned output sleep signal based on the evaluation criteria of the system. (Page 8, lines 24-33).
Lane, in a related field of endeavor, teaches a vital sign detection system wherein the management device is configured to prohibit the storage of the data corresponding to the vital sign associated with the first detection signal responsive to receiving the second detection signal from the second sensor. ((Paragraphs [0045], [0075] teaches using a Doppler filter to accept only reflected radar signals within a predetermined frequency range when determining the vital sign measurement. For example, objects having no motion, i.e., subject is in a bed with relatively little motion, and hence no Doppler signal, are removed when performing the method so that only a moving object is analyzed. Hence, a person in a resting or sleep state, i.e., an object having no motion would not be analyzed, and therefore corresponding data would not be stored/outputted.)
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the vital sign obtaining device of Armitstead to further teach “wherein the management device is configured to prohibit the storage of the data corresponding to the vital sign associated with the first detection signal” as contemplated by Lane “responsive to receiving the second detection signal from the second sensor”, as taught by Schuijers. Doing so subtracts background noise associated with the motionless objects thereby improving the quality of the vital sign measurement. (Paragraph [0037] of Lane).
Regarding claim 10, Armitstead does not teach “wherein the processing device is configured to determine whether to output the data to the management device, based on the second detection signal”.
Schuijers teaches wherein the processing device is configured to determine whether to output the data to the management device, based on the second detection signal. (Page 8, lines 24-33, In practice (not shown), in addition to providing the first sleep signal output 170, typically similar sleep output signals would be generated based on the conditioned signals from the second and further sensors using corresponding processing circuitry).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Armitstead to teach “wherein the processing device is configured to determine whether to output the data to the management device, based on the second detection signal” as taught by Schuijers. Doing so provides a conditioned output sleep signal based on the evaluation criteria of the system. (Page 8, lines 24-33).
Regarding claim 12, Armitstead teaches wherein the management device is configured to give, to the data, an index for evaluating a disease sign of the subject. (Paragraph [0010] apnea-hypopnoea index).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Armitstead in view of Schuijers and Lane, further in view of Heneghan (US 20180064388) (previously cited).
Regarding claim 2, Armitstead does not teach “wherein one of the plurality of classes is associated with an artifact superimposed on the vital sign”.
Heneghan, in a related field of endeavor, teaches a system for estimating sleep states of a user based on sensor data comprising a classifier wherein one of the plurality of classes is associated with an artifact superimposed on the vital sign. (Paragraph [0162] a sleep stage classifier may be trained by having a set of labeled data available, labels for epochs as being Wake, Light, Deep or REM, e.g., there may be different labels or additional labels, such as artefact and/or off-wrist labels).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Armitstead as modified to teach “wherein one of the plurality of classes is associated with an artifact superimposed on the vital sign” as taught by Heneghan. Doing so may maximize classification accuracy. (Paragraph [0162]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Armitstead in view of Schuijers and Lane, further in view of Kaplan (US 20160071393) (previously cited).
Regarding claim 9, Armitstead does not teach “wherein the first sensor has an operation period longer than a non-operation period”.
Kaplan, in a related field of endeavor, teaches alertness monitoring device wherein the first sensor has an operation period longer than a non-operation period. (Paragraph [0080] continuous monitoring of various sleep risk variables implies operation period is longer than a non-operation period).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Armitstead as modified to teach “wherein the first sensor has an operation period longer than a non-operation period” as taught by Kaplan. Doing so enables generation of dynamic risk levels for user fatigue. (Paragraph [0081]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 4/23/2026, with respect to the rejections of claims 1-5 7-10, and 12 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Lane is relied upon for the amended feature.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/ Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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